THE MEDICINES CONTROL COUNCIL

May 6, 1998 (Number 25)]

Proposed Regulations for the Control of Dietary Supplements and Complimentary Medicines

[Page 5699-5709]

From the office of the Chairman : Professor. Peter Folb

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Part IV

Department of Health

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MEDICINES CONTROL COUNCIL

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Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements and Complimentary Medicines; Proposed Rule

TO : DEPARTMENT OF HEALTH

FROM : MEDICINES CONTROL COUNCIL

21 CFR Ch. I

[Docket No. 98N-0417]

RIN 0910-AA59

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Complimentary Medicines

DEPARTMENT : MEDICINES CONTROL COUNCIL in collaboration with the FOOD CONTROL DIRECTORATE : Department of Health

ACTION: Advance notice of proposed rulemaking and inforcment.

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SUMMARY: The Medicines Control Council (MCC) is announcing that it wishes to institute rule-making to develop current good manufacturing practice (CGMP) regulations for dietary supplements and Complimentary Medicines. MCC solicits comments on whether it should do so, and if it should, what constitutes CGMP for these products. In issuing this notice, MCC is responding to the section of the Medicines Control Act 101 of 1965.(the act) that provides that the Minister of Health (the Minister) may, by regulation, prescribe good manufacturing practice for dietary supplements and Complimentary Medicines and to a submission from representatives of the dietary supplement industry (Health Products Association) asking MCC to consider a framework that the industry had developed as a basis for CGMP regulations.

MCC is publishing the industry submission which was tendered to the Technical Sub-Committee of the Complimentary Medicines Committee and is asking the Department's comment on the framework that the submission presents. In addition, MCC is requesting comment on a number of other related issues.

DATES: Written comments by July, 1998.

ADDRESSES: Submit written comments to the Dockets Management Secretary (MCC-35), Medicines Control Council.

FOR FURTHER INFORMATION CONTACT: Peter Folb : Department of Pharmacology, University Of Cape Town, Private Bag X321, Cape Town , 8000. E-Mail folb@uctgsh7.uct.ac.za

SUPPLEMENTARY INFORMATION:

I. Background

On November, 1994, the MCC restructured it's esteemed Complimentary Medicines Committee whose function was to democratically, and with all role-players, set standards for the future control and regulation of dietary supplements and Complimentary Medicines under Act 101 of 1965. The CMC have completed their duty and are requesting that the Minister pass as expediently as possible, regulations to prescribe good manufacturing practices for dietary supplements and Complimentary Medicine under the listings system.

Such regulations must be modelled after current good manufacturing practice regulations for drugs which fall under Act 101 at this present time and may not impose standards for which there is no current and generally available analytical methodology.

No standards of current good manufacturing practice are presently imposed unless such standard is included in regulation promulgated under Act 101 of 1965.

While the present Act does not require that the Minister (and by delegation, MCC) adopt regulations that prescribe CGMP, the significant majority of the dietary supplement and Complimentary Medicine industry has told the agency that such regulations would be helpful for ensuring that dietary supplements are safe for their intended use and that the public will be protected.

On April 20, 1997, representatives of the dietary supplement and Complimentary Medicines (Health Products Association Technical Committee)industry submitted to MCC a suggested outline for the development of CGMP regulations for dietary supplements and Complimentary Medicines. MCC evaluated the outline and determined that it provided an extremely useful starting point should MCC decide to proceed to rule making to adopt such high regulations. We would certainly welcome such a move, considering South Africa is a members of a CODEX commission where such enforcement world-wide will become standard practice by 1999, through CODEX mandate.

However, the Council recognises that the first question that must be addressed is whether there is a need for such regulations or whether Act 101 continues to be adequate. The Council also recognises that if it decides that there is a need for CGMP regulations, certain issues were not addressed in the submission, and that other interested parties, such as consumers, pharmapact, segments of the industry not represented by the manufacturers and trade association who submitted the outline, and the health care community, should have an opportunity to provide comment before the Council develops these measures in 1999. We would like to add, however, that the MCC have continually requested meeting with spoiler groupings, but to no avail. The single, largest obstacle we face is that the consumers and other such groupings feel they have a right to these substances without our proposed regulations. Therefore, the Council is issuing this notice to solicit comments and other information on whether it should propose new CGMP regulations for dietary supplements and Complimentary Medicines and, if it should, what those regulations should include.

Based on the submission and the comments that the Council receives in response to this notice, MCC will consider whether to develop a proposed rule that is designed to establish CGMP that will ensure that dietary supplements and Complimentary Medicines are produced under strict conditions that will result in a safe and properly labeled product but that does not impose any unnecessary burden on the pharmaceutical industry.

II. The Industry Submission

A. Introduction

On April 20, 1997, MCC met with representatives of the dietary supplement industry at their request (Ref. 1). At that meeting, the industry representatives submitted a document that outlined suggested CGMP for dietary supplements (Ref. 2). The objectives of the CGMP, as stated by the industry representatives, are to ensure that consumers are provided with dietary supplement products that: (1) Are safe and not adulterated or misbranded; (2) have the identity and provide the quantity of dietary ingredients declared in labeling; and (3) meet the quality specifications that the supplement is represented to meet.

The industry submission through the CMC and HPA was patterned after the CGMP for drug regulation contained in Act 101 of 1965, but also contained requirements beyond those in the Act that the industry representatives stated that " they consider essential to the manufacture of safe and properly labeled dietary

Supplements and Complimentary Medicines, as all herbs and especially Homeopathic Medicines are not safe. " MCC is publishing the industry suggested dietary supplements and Complimentary Medicines CGMP and soliciting comments from your Department on the need for dietary supplement CGMP regulations and on the requirements that should be included in such regulations in South Africa so that we may lead the international trend through recommendations the the World Health Organisation and CODEX in Berlin later this year.

B. The Industry Draft

The text of the industry suggested dietary supplements CGMP follows:

Good Manufacturing Practices (GMP's) for Dietary Supplements: Statement of Purpose

This document describes Good Manufacturing Practices to be followed in the manufacturing and control operations for dietary supplements and dietary ingredients, including Complimentary Medicines and Traditional Medicines. The objective of these Good Manufacturing Practices is to assure that consumers are provided with safe dietary supplement products which are not adulterated or misbranded, which have the identity and provide the quantity of dietary ingredients declared in labeling, and which meet the quality specifications that the supplement is represented to meet.

We believe that the Medicines Control Act. 101 of 1965 defines dietary supplements, complimentary medicines and traditional medicines as medicines under the Act.

Dietary supplements include a broad spectrum of product forms and a broad spectrum of dietary ingredients. Dietary ingredients may include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances used to supplement the diet; and concentrates, metabolites, constituents, extracts, or combinations of these. This also applies to traditional health substances in the African model of health care support.

Product forms include tablets, capsules, softgels, gelcaps, liquids, and other forms including - under some conditions - conventional food forms. These Good Manufacturing Practices are intended to encompass all of these types of products.

In some cases, judgement may be required in determining the applicability of a specific provision to a particular product or class of products. Dietary supplements and Complimentary medicines in the physical form of conventional food shall comply with these regulations.

These Good Manufacturing Practices are modelled after good manufacturing practices for drugs. Provisions have been adopted, modified, or expanded as appropriate, considering the special requirements applicable to the manufacture of dietary supplements, dietary ingredients and other Complimentary medicines.

There is no desire or intent to impose on dietary supplements the type of documentation and validation currently required in the manufacture of pharmaceutical products as yet, however these will be necessary in due course as the industry establishes itself in belief of protection.

We believe that all supplements and Complimentary medicines should be classified as pharmaceutical substances, and the Good Manufacturing Practices applicable to them are similar to those generally applicable to other pharmaceutical substances in an imperative pubic protection plan directed by the World Health Organisation.

Proposed Supplement and Complimentary Medicine GMP

Definitions

The definitions and interpretations of terms in section 9 of the Medicines Control Act 101. Of 1965 are applicable to such terms when used in this part. The following definitions shall also apply:

(a) ``Adequate'' means that which is needed to accomplish the intended purpose in keeping with good public health practice.

(b) ``Batch or Lot'' means a specific quantity of a finished product or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

(c) ``Blanching'' means a prepackaging heat treatment of a dietary product or Complimentary Medicine for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the product.

(d) ``Composition'' means, as appropriate:

(1) the identity of a dietary ingredient, dietary supplement,traditional health substance and

(2) the concentration of a dietary ingredient (e.g., weight or other unit of use/weight or volume), or the potency or activity of one or more dietary ingredients, as indicated by appropriate procedures.

(e) ``Dietary Supplement Ingredient or Complimentary Medicine Ingredient'' means an ingredient intended for use or used in a dietary supplement that is:

(1) a vitamin,

(2) a mineral,

(3) an herb or other botanical,

(4) an amino acid,

(5) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or

(6) a concentrate, metabolite, constituent, extract, or combination of any of the foregoing ingredients.

(f) "`Dietary Product / Supplement" , "Complimentary Medicine" , "Traditional Medicine" means either a dietary ingredient or dietary supplement as defined in this Part.

(g) ``Dietary supplement'' means dietary supplement as defined in the Act.

(h) ``In-process material'' means any material fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction or processed in any other way that is produced for, and used in, the preparation of a dietary product or Complimentary Medicine.

(i) ``Lot'' means ``batch'' as defined in this part.

(j) ``Lot number'' means any distinctive combination of letters, numbers, or symbols, or any combination of them from which the complete history of the , pre-screening, assays, manufacture, processing, packing, holding, and distribution of a batch or lot of a finished dietary ingredient, dietary supplement, and Complimentary Medicines or other material can be determined.

(k) ``Manufacture'' or ``manufacturing'' includes all operations associated with the production of dietary products, including packaging and labeling operations, testing, and quality control of a dietary ingredient or dietary supplement by means of chromatographs, stability testings, and toxicological testings.

(l) ``Microorganisms'' means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term ``undesirable microorganisms'' includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that a dietary ingredient or dietary supplement is contaminated with filth, or that otherwise may cause a dietary product to be adulterated within the meaning of the Act. Occasionally in these regulations, the adjective ``microbial'' is used instead of using an adjectival phrase containing the word microorganism.

(m) ``Pest'' refers to any objectionable animals or insects including, but not limited to, bird, rodents, flies, and larvae.

(n) ``Plant'' means the registered pharmaceutical facility or parts thereof, used for or in connection with the manufacturing, packaging, labelling, or holding of a dietary product or Complimentary medicine.

(o) ``Quality control operation'' means a planned and systematic procedure for taking all actions necessary to prevent a dietary product from being adulterated within the meaning of the current Act. This must be administered by personnel who are registered pharmacists in accordance with the Pharmacy Act.

(p) ``Quality control unit'' means any person or organisational element designated by the firm to be responsible for the duties relating to quality control operations. As above refers.

(q) ``Raw material'' means any ingredient intended for use in the manufacture of a dietary ingredient, dietary supplement, traditional medicine, or complimentary medicine including those that may not appear in such finished product.

(r) ``Representable sample'' means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and is intended to assure that the sample accurately portrays the material being sampled. Such samples shall be analysed at the respective company's expense and may be carried out at any time in the interest of public safety.

(s) ``Rework'' means clean, unadulterated material that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use in the manufacture of a dietary product or complimentary medicine.

(t) ``Sanitize'' means to adequately treat equipment, containers, or utensils by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

(u) ``Shall'' is used to state mandatory requirements.

(v) ``Should'' is used to state recommended or advisory procedures or identify recommended equipment.

(w) "Water activity" is a measure of the free moisture in a dietary ingredient, dietary supplement or complimentary medicine and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

Personnel

The plant management shall take all reasonable measures and precautions to assure the following:

(a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of an in-process or finished dietary product becoming adulterated, or processing equipment, utensils or packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such adulteration or contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.

(b) Cleanliness. All persons working in direct contact with raw materials, in-process or finished dietary products, processing equipment, utensils or packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against adulteration or contamination of such materials. The methods for maintaining cleanliness include, but are not limited to:

(1) Wearing outer garments suitable to the operation in a manner that protects against the adulteration of in-process or finished dietary products or complimentary medicines, or contamination of processing equipment, utensils or packaging materials.

(2) Maintaining adequate personal cleanliness.

(3) Washing hands thoroughly (and sanitising if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.

(4) Removing all unsecured jewellery and other objects that might fall into raw materials, in-process or finished dietary product, equipment, or containers, and removing hand jewellery that cannot be adequately sanitised during periods in which in-process or finished product is manipulated by hand. If such hand jewellery cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the adulteration of dietary products or contamination of processing equipment, utensils or packaging materials.

(5) Maintaining gloves, if they are used in-process or finished product handling, in an intact, clean, and sanitary condition. The gloves should be of a material that adequately protects the product from contamination.

(6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints.

(7) Storing clothing or other personal belongings in areas other than where in-process or finished product is exposed or where processing equipment or utensils are washed.

(8) Confining the following to areas other than where in-process or finished product may be stored or exposed, or where processing equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.

(9) Taking any other necessary precautions to protect against adulteration of raw materials, in-process or finished product, or contamination of processing equipment, utensils or packaging materials with micro-organisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.

(c) Education and training.

Each person engaged in the manufacture of a dietary product should have the proper education, training, and experience (or any combination thereof) needed to perform the assigned functions. Training should be in the particular operation(s) that the employee performs as they relate to the employee's functions. Appropriate documentation of training shall be retained by the manufacturer and will be set out by the MCC.

(d) Supervision.

Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to qualified personnel with proper education, training and experience (or any combination thereof). Such persons must be registered as Pharmacists in the Republic of South Africa.

Exclusions

The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one or more ``raw agricultural commodities,'' as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public.

Plant and Grounds

(a) Grounds. The grounds about a dietary product and complimentary medicine manufacturing plant under the control of the operator shall be kept in a condition that will protect against the adulteration of dietary products. The methods for adequate maintenance of grounds include, but are not limited to:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.

(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of adulteration in areas where product is exposed.

(3) Adequately draining areas that may contribute to product adulteration by seepage, foot-borne filth, or providing a breeding place for pests.

(4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of adulteration in areas where product is exposed. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a)(1) through (3) of this section, care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of product adulteration.

(b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction. and design to facilitate maintenance, cleaning and sanitary operations for pharmaceutical manufacturing purposes and to prevent mixups between different raw materials and products.

The plant and facilities shall:

(1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the prevention of mixups, maintenance of sanitary operations and the production of safe dietary products and complimentary medicines.

(2) Permit the taking of proper precautions to reduce the potential for mixups or adulteration of in-process or finished dietary product/complimentary medicine, or contamination of processing equipment, utensils or packaging materials with microorganisms, chemicals, filth, or other extraneous material.

The potential for mixups and product adulteration may be reduced by adequate product safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: Location, time, partition, air flow, enclosed systems, or other effective means.

(3) Permit the taking of proper precautions to protect dietary ingredients or dietary supplements in outdoor bulk fermentation vessels by any effective means, including:

(i) Using protective coverings.

(ii) Controlling areas over and around the vessels to eliminate harborages for pests.

(iii) Checking on a regular basis for pests and pest infestation.

(iv) Skimming the fermentation vessels, as necessary.

(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not adulterate raw materials, in-process or finished dietary products and complimentary medicines, or contaminate product containers, utensils or packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protec against adulterating in-process or finished product, or contaminating processing equipment with clothing or personal contact.

(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where product is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, sky-lights, or other glass suspended over exposed product in any step of preparation or otherwise protect against product adulteration in case of glass breakage.

(6) Provide adequate ventilation or control equipment to maintain adequate control over microorganisms, dust, humidity, and temperature, when appropriate, for the manufacture of dietary products and complimentary medicines; to minimise doors and vapours (including steam and noxious fumes) in areas where they may adulterate dietary products; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for adulterating raw materials, in- process or finished dietary products, or contaminating processing equipment, utensils or packaging materials.

(7) Provide, where necessary, adequate screening or other protection against pests.

Sanitation of Buildings and Facilities

(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent raw materials, in-process or finished dietary products from becoming adulterated within the meaning of the act. No manufacture will be allowed in a private home, or in any area adjoining a private home

(b) Cleaning and sanitising materials.

(h) Hand-washing facilities. Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing: Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.

(2) Effective hand-cleaning and sanitizing preparations.

(3) Air driers, sanitary towel service or suitable drying devices.

(4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.

(5) Readily understandable signs directing employees handling unprotected product, packaging materials, utensils or processing equipment to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such products, materials, utensils or equipment.

(6) Refuse receptacles that are constructed and maintained in a manner that protects against adulteration of dietary products.

(i) Rubbish disposal. Rubbish shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against adulteration of raw materials, in-process or finished dietary products, or contamination of utensils, processing equipment, water supplies, and ground surfaces.

(j) Supervision. Overall sanitation of the plant shall be under the supervision of one or more individuals qualified by education, experience and training (or any combination thereof) assigned responsibility for assuring that sanitation procedures are accomplished.

Equipment and Utensils

(a) Design and construction.

(1) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained.

(2) The design, construction and use of equipment and utensils shall preclude the adulteration of raw materials, packaging materials, in-process materials or finished product with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.

(3) All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Processing equipment and utensils shall be corrosion-resistant when in contact with raw materials, in-process or finished dietaryproduct or complimentary medicine. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of dietary products, and, if applicable, cleaning compounds and sanitizing agents. Processing equipment and utensils shall be maintained to protect dietary products from being adulterated by any source.

(4) Seams on utensils and processing equipment shall be smoothly bonded or maintained so as to minimize accumulation of product, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.

(5) Equipment that is in the manufacturing or product handling area and that does not come into contact with a dietary product shall be so constructed that it can be kept in a clean condition.

(6) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate clean condition.

(7) Each freezer and cold storage compartment used to store and hold a dietary product capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment, and should be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation.

(8) Instruments and controls used in the manufacture, processing, packing or holding dietary products, including instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in such products shall be accurate and adequately maintained, and adequate in number for their designated uses.

(9) Compressed air or other gases mechanically introduced into a dietary product or complimentary medicine or used to clean equipment or utensils shall be treated in such a way that dietary ingredients, dietary supplements and complimentary medicines are not adulterated.

(b) Sanitation of equipment and utensils.

1) Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against adulteration of raw materials, in-process or finished dietary product, processing equipment, utensils or packaging materials.

(2) All utensils and processing equipment shall be cleaned as frequently as necessary to protect against product adulteration.

(3) Utensils and processing equipment used for manufacturing or holding of dry dietary products shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitised and thoroughly dried before subsequent use.

(4) In wet processing, when cleaning is necessary to protect against the introduction of micro-organisms into a dietary product or complimentary medicine, all utensils and processing equipment shall be cleaned and sanitised as appropriate before use and after any interruption during which the utensils or processing equipment may have become contaminated.

Where equipment and utensils are used in a continuous production operation or in back-to-back operations involving different batches of the same products, the utensils and product-contact surfaces of the equipment shall be cleaned and sanitised as appropriate.

(5) Non-product-contact surfaces of equipment should be cleaned as frequently as necessary to protect against product adulteration.

(6) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against adulteration of dietary products and complimentary medicines, and contamination of utensils and processing equipment.

(7) Sanitising agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitising equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitising treatment.

(8) Cleaned and sanitised portable equipment with product-contact surfaces and utensils should be stored in a location and manner that protects product-contact surfaces from contamination.

(9) Equipment and utensils and finished product containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.

(10) Written procedures shall be established and followed for cleaning and maintaining equipment and utensils used in the manufacture of dietary products and complimentary medicines.

(11) A written record of major equipment cleaning and use shall be maintained in individual equipment logs that show the date, product and lot number of each batch processed. The persons performing the cleaning shall record in the log that the work was performed. Entries in the log should be in chronological order.

(12) Equipment, containers, and utensils used to convey, hold, or store raw materials, in-process material, rework, or finished product shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

Quality Control and Laboratory Operations

Appropriate quality control operations shall be employed to assure that dietary products and comlimentary medicines conform to appropriate standards of purity, quality and composition, and that packaging materials are safe and suitable for their intended purpose.

(a) Quality control unit.

(1) There shall be a quality control unit that has the responsibility and authority to:

(i) Approve or reject all procedures, specifications, controls, tests and examinations, or deviations from them, that impact the purity, quality and composition of a dietary ingredient or dietary supplement and complimentary medicines;

(ii) Approve or reject all raw materials, packaging materials labeling, and finished dietary products, including products manufactured. processed, packed, or held under contract by another company, based on adequate determination of conformance to established specifications; and

(iii) Assure that completed production records are reviewed as appropriate. Quality control shall be responsible for evaluation of errors committed in the manufacture of a product and shall have the final authority to determine if the error may be corrected in such manner that the product can be approved for distribution or must be destroyed. Such evaluations and their resolution must be documented and maintained with and/or cross referenced in the batch production record.

(2) Adequate laboratory facilities should be available, as needed, to the quality control unit.

(3) The responsibilities and procedures applicable to the uality control unit shall be established in writing and followed.

(b) Laboratory records. Laboratory records shall be maintained nd shall include complete data derived from all specified tests.

(c) Expiration dating.

(1) Whenever a dietary ingredient, dietary supplement, comlimentary medine, or traditional health substanc is used it must be supported certificates that the product meets established specifications at the expiration date.

(2) Appropriate accelerated stability studies or data from similar product formulations may be used for an initial determination of shelf life. Product shelf life shall be confirmed and may be extended on the basis of real time studies on product stored under labeled storage conditions.

Production and Process Controls

a) Master production and control records.

(1) To assure uniformity from batch to batch, a master production and control record shall be prepared for the manufacture of each dietary ingredient and dietary supplement, and shall be reviewed and approved by the quality control unit.

(2) Master production and control records shall include, as appropriate.

(i) A complete list of raw materials used in the manufacture of a dietary product, designated by names or codes sufficiently specific to indicate any special quality characteristic(s).

(ii) An accurate statement of the weight or measure of each raw material used in the manufacture of a dietary product. Each batch shall be formulated with the intent to provide not less than 100 percent of each claimed dietary ingredient.

(iii) For dietary supplements, the name and weight or measure of each dietary ingredient per unit or portion or per unit of weight or measure of the supplement. This equally applies to complimentary medicines.

(iv) A statement concerning any calculated excess of dietary ingredient contained in a dietary supplement. This equally applies to complimentary medicines.

(v) A statement of the total weight or measure of any dietary supplement unit. This equally applies to complimentary medicines.

(vi) A statement of theoretical weight or measure of a dietary ingredient or dietary supplement expected at the conclusion of manufacture, including the maximum and minimum percentages of theoretical yield beyond which investigation is required. This equally applies to complimentary medicines.

(vii) A description of the product container(s), closure(s), and other packaging materials, including positive identification of all labeling used.

(viii) Manufacturing and control instructions, designed to assure that the dietary product has the purity, composition, and quality it is represented to possess.

(b) Batch production and control records.

(1) Individual batch production and control records shall be prepared and followed for each batch of dietary product produced and shall include complete information relating to the production and control of each batch.

(2) These records shall be an accurate reproduction of the appropriate master production and control record and shall include documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:

(i) Dates;

(ii) Identity of individual major equipment and lines used;

(v) Quality control results;

(vi) Inspection of the packaging and labeling area;

(ix) Description of product containers and closures used; and

(1) Raw materials, in-process materials and rework shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into dietary products and shall be stored under conditions that will protect against adulteration and minimise deterioration.

Containers of raw materials should be inspected on receipt to assure that their condition has not contributed to the adulteration or deterioration of the contents. Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

(2) Raw agricultural materials that contain soil or other contaminants shall be washed or cleaned as necessary. Water used for washing, rinsing, or conveying raw agricultural materials shall be safe and of adequate sanitary quality. Notwithstanding the general requirement for potable water, water may be reused for washing, rinsing, or conveying raw agricultural materials, if it does not increase the level of contamination of the such materials.

(3) Raw materials, in-process materials, and rework shall be held in bulk, or in containers designed and constructed so as to protect against adulteration and shall be held at such temperature and relative humidity and in such a manner as to prevent a dietary ingredient or dietary supplement from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.

(4) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the Act.

(5) Written procedures shall be established and followed describing the receipt, identification, examination, handling, sampling, testing and approval or rejection of raw materials.

(6) Each lot of raw material shall be identified with a distinctive lot number and shall be appropriately controlled according to its status (e.g., quarantined, approved, rejected).

(7) Raw material samples shall be examined and tested as follows:

(i) Each lot of raw material, in-process material, and rework that is liable to adulteration with filth, insect infestation, or other visually evident extraneous material shall be examined against established specifications for such adulteration, and shall comply with any MCC guidelines. In lieu of such examination by the manufacturer, a guarantee or certification of examination may be accepted from the supplier of a component provided that the manufacturer establishes the reliability of the supplier's examination.

(ii) Each lot of a raw material (especially herbs) that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. Raw materials shall either not contain levels of microorganisms that may produce poisoning or other disease in humans, or they shall be otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the Act.

In lieu of such testing by the manufacturer, a guarantee or certification of analysis must be soursed from the supplier of a component provided that the MCC establishes the reliability of the supplier's analyses.

(iii) Raw materials and other ingredients susceptible to adulteration with aflatoxin or other natural toxins shall comply with current MCC guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into a finished dietary ingredient or dietary supplement. Compliance with this requirement may be accomplished by analyzing these materials and ingredients for aflatoxins and other natural toxins or, in lieu of such testing by the manufacturer, a guarantee or certification of analysis may be accepted from the supplier of a component provided that the manufacturer establishes the reliability of the supplier's analyses.

(iv) Each lot of raw material shall undergo at least one test by the manufacturer to verify its identity. Such tests may include any appropriate test with sufficient specificity to determine identity, including chemical and laboratory tests, gross organoleptic analysis, microscopic identification, or analysis of constituent markers.

(v) Each lot of raw material shall be tested for conformity with all other established specifications. In lieu of such testing by the manufacturer, a guarantee or certification of analysis may be accepted from the supplier of a component provided that the manufacturer establishes the reliability of the supplier's analyses.

(8) Approved raw materials shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.

(9) Raw materials shall be re-tested or re-examined and approved or rejected by the quality control after a specified time in storage or after exposure to air, heat, or other conditions that are likely to adversely affect the purity, quality, or composition of the raw material.

(10) Rejected raw materials, shall be identified and controlled under a system that prevents their use in manufacturing or processing operations for which they are unsuitable.

(d) Manufacturing operations.

(1) All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of dietary products and complimentary medicines shall be conducted in accordance with adequate sanitation principles.

(2) All reasonable precautions shall be taken to assure that production procedures do not contribute adulteration from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible product adulteration.

(3) All product that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected and destroyed, or if permissible, treated or processed to eliminate the contamination.

(4) All product manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimise the potential for the growth of micro-organisms, or for the adulteration of raw materials, in-process materials and finished product.

(5) Measures such as sterilising, irradiating, pasteurising, freezing, refrigerating, controlling pH or controlling water activity that are taken to destroy or prevent the growth of undesirable micro-organisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent dietary products from being adulterated within the meaning of the act.

(6) Work-in-process shall be handled in a manner that protects against adulteration.

(7) Effective measures shall be taken to protect finished dietary ingredients, dietary supplements, and complimentary medicines from adulteration by raw materials, in-process materials or refuse. When raw materials, in-process materials or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in adulterated dietary products. Dietary ingredients, dietary supplements, and complimentary medicines transported by conveyor shall be protected against adulteration as necessary.

(8) All raw material containers, compounding and storage containers, processing lines and major equipment used during the production of a batch shall be properly identified at all times to indicate their contents and when necessary, the phase of processing of the batch.

(9) Effective measures shall be taken as necessary to protect against the inclusion of metal or other extraneous material in product. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

(10) Dietary products, raw materials, and in-process materials that are rejected or adulterated within the meaning of the act shall be identified, stored and disposed of in a manner that protects against the adulteration of other products.

(11) Written procedures shall be established and followed that describe appropriate tests, and /or examinations to be conducted that may be necessary to assure the purity, composition, and quality of the finished product.

(12) Written procedures shall be established and followed prescribing the method for reprocessing batches or operational start-up materials that do not conform to finished goods standards or specifications. Finished goods manufactured using such materials shall meet all established purity, composition, and quality standards.

(13) Mechanical manufacturing steps such as cutting, sorting, inspecting, shredding, drying, grinding, blending, and sifting shall be performed so as to protect dietary ingredients, dietary supplements and complimentary medicines against adulteration. Compliance with this requirement may be accomplished by providing adequate physical protection of dietary products from contact with adulterants. Protection may be provided by adequate cleaning and sanitizing of all processing equipment between each manufacturing step.

(14) Heat blanching, when required in the preparation of a dietary product, should be effected by heating the product to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the material or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched product is washed prior to filling, potable water shall be used.

(15) Intermediate or dehydrated dietary products that rely on the control of water activity for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) Monitoring the water activity of the material.

(ii) Controlling the soluble solids-water ratio in finished product.

(iii) Protecting finished product from moisture pickup, by use of a moisture barrier or by other means, so that the water activity of the product does not increase to an unsafe level.

(16) Dietary ingredients, dietary supplements, and complimentary medicines that rely principally on the control of pH for preventing the growth of undesirable micro-organisms shall be monitored and maintained at an appropriate pH. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) Monitoring the pH of raw materials, in process material, and finished product.

(ii) Controlling the amount of acid added to the product.

(17) When ice is used in contact with pro-biotic products, it shall be made from potable water, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in the Act.

(e) Packaging and labelling operations.

(1) Filling, assembling, packaging, and other operations shall be performed in such a way that dietary products and complimentary medicines are protected against adulteration.

Compliance with this requirement may be accomplished by any effective means, including:

(i) Adequate cleaning and sanitizing of all filling and packaging equipment, utensils, and product containers, as appropriate to the MCC.

(ii) Using materials for product containers and packaging materials that are safe and suitable.

(iii) Providing physical protection from adulteration, particularly airborne contamination.

(iv) Using sanitary handling procedures.

(2) Written procedures shall be established and followed describing in sufficient detail the control procedures employed for the receipt, storage, handling, sampling, examination, and/or testing that may be necessary to assure the identity of labeling and the appropriate identity, cleanliness and quality characteristics of packaging materials for dietary products and complimentary medicines.

(3) For dietary supplements and complimentary medivcines, labels and other labeling materials for each different product type, strength, or quantity of contents shall be stored separately with suitable identification.

(4) Obsolete labels, labelling, and other packaging materials for dietary products shall be destroyed.

(5) Written procedures shall be established and followed to assure that correct labels, labelling, and packaging materials are issued and used for dietary products and complimentary medicines.

(6) Dietary ingredient, dietary supplement, and complimentary medicine packages shall be identified with a lot number that permits determination of the history of the manufacture and control of the batch.

(7) Packaged and labelled dietary supplements and complimentary medicines shall be examined to provide assurance that containers and packages in the lot have the correct label and lot number. Products not meeting specifications shall be rejected by the quality control unit.

(8) Every active ingredient must be listed on the packaging. All accipients must be added to the list of ingredients. For plant substances, the common name, botanical name, and part of the plant part/s used must be identified.

Warehousing, Distribution and Post-Distribution Procedures

(1) Storage and transportation of finished product shall be under conditions that will protect product against physical, chemical, and microbial adulteration as well as against deterioration of the product and the container.

(2) Adequate distribution records shall be maintained and retained by the manufacturer at least 1 year beyond expected product shelf life, whereby an effective product recall can be achieved should one become necessary.

(b) Reserve samples. An appropriately identified reserve sample that is representative of each batch of a dietary product should be retained and stored under conditions consistent with the product labeling until at least 1 year after the expiration date, or if no expiration date is identified on the product, for at least 3 years after the date of manufacture. The reserve sample should be stored in the same immediate container-closure system in which the finished product is marketed or in one that provides similar protection. The reserve sample shall consist of at least twice the quantity necessary to perform all the required tests.

(c) Records retention.

(1) Any laboratory, production, control or distribution record specifically associated with a batch of product shall be retained for at least 1 year after the expiration date of the batch, or if no expiration date is identified on the product, for at least 3 years after the date of manufacture.

(2) Raw material records shall be maintained for at least 1 year after the expiration date of the last batch of product incorporating the raw material, or if no expiration date is identified on the product, for at least 3 years after the date of manufacture of the finished product.

 d) Complaint files.

Written procedures describing the handling of all written and oral complaints regarding a dietary product or complimentary medicine shall be established and followed up by the MCC.

Such procedures shall include provisions for review by the MCC involving the possible failure of a product to meet any of its specifications and, for such products, a determination as to the need for an investigation.

(2) A written record of each complaint shall be maintained, until at least 1 year after the expiration date of the product, or 1 year after the date that the complaint was received, whichever is longer.

(3) The written record shall include, where known: The name and description of the product, lot number, name of complainant, nature of complaint, and reply to complainant, if any.

(4) Where an investigation is conducted, the written record shall include the findings of the investigation and followup action taken.

(e) Returned products. Returned dietary products and complimentary medicnes shall be identified as such and held. If the conditions under which returned dietary products have been held, stored, or shipped before or during their return, or if the condition of the product, its container, carton, or labeling as a result of storage or shipping, casts doubt on the purity, composition or quality of the product, the returned product shall be destroyed unless examination, testing, or other investigations prove the product meets appropriate standards of purity, composition, and quality.

A product may be reprocessed provided the subsequent product meets appropriate specifications. Records pertaining to returned products that are subsequently reprocessed and/or redistributed shall be maintained and shall include the name and description of the product, lot number, reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned product.

(f) Product salvaging.

Dietary products and complimentary medicines that have been subjected to improper storage conditions including extremes in temperature, humidity smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace.

Whenever there is a question whether products have been subjected to such conditions, salvaging operations may be conducted only if there is: (1) Evidence

from laboratory tests that the products meet all applicable standards of purity, quality, and composition; and (2) evidence from inspection of the premises that the products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident. Records including name, lot number, and disposition shall be maintained for products subject to this section.

(g) Defect action levels.

(1) Some dietary ingredients, dietary supplements, and complimentary medicines even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The MCC establishes maximum levels for these defects in dietary products produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.

(2) Defect action levels are established for dietary products and complimentary medicines whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information.

(3) Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that dietary products and complimentary medicines not be prepared, packed, or held under unsanitary conditions or the requirements in this part that dietary product and complimentary medicne manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes a dietary product to be adulterated within the meaning of the Act, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of a dietary product shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.

(4) The mixing of a dietary ingredient, dietary supplement, or complimentary medicine containing defects above the current defect action level with another lot of dietary ingredient or dietary supplement is not permitted and renders the final product adulterated within the meaning of the act, regardless of the defect level of the final product.

(5) A compilation of the current defect action levels for natural or unavoidable defects in dietary products and complimentary medicines that present no health hazard may be obtained upon request from the MCC.

III. Economic Issues

The MCC sees a lot of scope for dietary supplements and complimentary medicines in the pharmaceutical marketplace in South Africa. Many pharmaceutical companies have indicated that the world is changing and that the access to these substances from competent health care providers such as pharmacies, and medical personal is a dream, which can unfold into a fruitfull extension of current pharmaceutical markets.

We request comment on and descriptions of CGMP in the dietary supplement and complimentary medicine industry from your Department. The MCC seeks information on how closely the current practices of firms manufacturing dietary supplements conform to the industry submission, and on how costly it would be to bring those practices into conformity. This has already been achieved by assesing the companies applications to list their products under such a standard.

The establishment of CGMP could have effects on small businesses in the dietary supplement industry. There are several possible definitions of ``small'' that can be applied to dietary supplements and complimentary medicines. Although the Small Business Development Corporation (Mr. Allan Thomlanson) (SBDC) does not define small for the dietary supplement industry, the industry's products are generally closest to pharmaceutical medicines. MCC asks for comments on this matter.

IV. Summary and Request for Comments

MCC asks for comments on the regulatory framework presented in this joint MCC and HPA industry submission in section II. of this document and the economic issues discussed above. In addition, the Council requests comments from your department on the following issues:

1. Is there a need to develop specific defect action levels (DAL's) for dietary ingredients and complimentary medicines ? While MCC has established DAL's for many food ingredients, including botanical food ingredients, these DAL's reflect their use for specific purposes, for example, the use of many botanicals as spices, flavorings, or other trace ingredients in foods. The DAL's are designed to provide reasonable assurance of the safety and wholesomeness of the ingredient when it is present in the food supply in small quantities. However, the use of a botanical in a dietary supplement or complimentary medicine will result in a much greater exposure to the botanical ingredient for consumers because the dietary supplement or complimentary medicine will be consumed in greater amounts than if the ingredient was in a food as a spice or flavoring agent.

Therefore, the MCC tentatively concludes that it would not be appropriate to apply the current DAL's to dietary supplements, and the agency requests comments that would assist in developing DAL's for dietary supplements. At present the listing proposal has lists of substances, and maximum dosage. This may be aqequate.

2. The MCC requests comments on appropriate testing requirements to provide positive identification of dietary ingredients, particularly plant materials, used in dietary supplements. The misidentification of dietary ingredients, particularly plant materials, used in dietary supplements may present a significant public health and economic concern since these are dangerous substances in the wrong hands.

However, the analytical methodology available for identifying many dietary ingredients and herbs is limited. Furthermore, the Act presently states that CGMP regulations may not impose standards for which there is no current and generally available analytical methodology.

MCC is asking for comments on the technical and scientific feasibility for the identification of different types of dietary ingredients and botanicals. The Council also solicits information on what constitutes ``adequate testing'' for identity of different types of ingredients, and, in the absence of testing, what types of practices would be effective alternatives to testing to ensure the identity of different types of dietary ingredients and botanicals.

3. MCC requests comments on standards that should be met in certifying that a dietary ingredient or dietary supplement is not contaminated with filth; that it is free of harmful contaminants, pesticide residues, or other impurities; that it is microbiologically safe; and that it meets specified quality and identity standards. For food it is CGMP for a manufacturer to accept certification from a supplier that products do not contain microorganisms or filth or other foreign material that would adulterate the product in lieu of direct testing or evaluation of the raw materials or final product. However, many ingredients used in dietary supplements, complimentary medicnes and botanicals do not have a history of food use in South Africa, and thus the potential for contamination with microorganisms or filth is unknown.

The MCC does not have information that provides a basis for it to determine whether certification by a supplier provides adequate assurance that a dietary ingredient is what it purports to be and is not adulterated. Therefore, the MCC asks for comments on whether a certification will provide assurance that dietary ingredients are not contaminated, or whether specific testing requirements are necessary and would effectively ensure the safety and wholesomeness of these products. The MCC requests that they be responsible for testing and that the companies involved, be requested by law to pay for such services.

4. CGMP is intended to ensure that a firm follows quality control and other procedures necessary to ensure that a food is safe for its intended use. It is possible that a firm will develop adequate standard operating procedures and other mechanisms to achieve this end, but that such procedures will not be followed. The agency asks for comments on whether there is a need for CGMP to include requirements for manufacturers to establish procedures to document that the procedures prescribed for the manufacture of a dietary supplement or complimentary medicine are followed on a continuing or day-to-day basis.

MCC is aware that no provision in the current Act with the establishment of documentation that a manufacturer is following established procedures prescribed for the manufacture of a dietary supplement or complimentary medicine, and that the act states that any CGMP regulations for dietary supplements are to be modeled after the CGMP regulations for pharmaceutical drugs. However, MCC's tentative judgment is that section of the act does not preclude MCC from adopting CGMP regulations for dietary supplements and complimentary medicines that have no counterpart if there is an appropriate basis for so doing. MCC requests comments from the Department of Health on this issue.

5. The Council asks for comments on whether dietary supplement or complimentary medicine CGMP should require that reports of injuries or illnesses to a firm be evaluated by competent medical authorities to determine whether followup action is necessary to protect the public health. Many dietary supplements and complimentary medicines contain pharmacologically active substances, and some many contain potential allergens that result in adverse events in certain consumers.

The presence of pharmacologically active substances in these products distinguishes them from foods. Because of the potential for serious injury or illness in some persons from the consumption of such substances, it may be necessary that trained medical professionals, rather than quality control or nonmedical scientific/regulatory personnel, evaluate all reported adverse events associated with the use of a specific substance and advise responsible management of their findings. Efficacy for these products must be established through medical trials.

MCC also asks for comments on whether CGMP for dietary supplements should contain a requirement that a firm establish procedures for determining whether a reported injury constitutes a serious problem, and what actions are to be taken when serious problems are identified.

6. The Council asks for comments on whether certain, or all, of the requirements for manufacturing and handling dietary ingredients, dietary supplements and complimentary medicines may be more effectively addressed by a regulation based on the principles of Hazard Scientific Analysis and Critical Control Points (HSACCP), rather than the system outlined in the industry submission, e.g. traditional usage claims, etc.

7. The dietary supplement and complimentary medicne industry includes a broad spectrum of firms that conduct one or more distinct operations, such as the manufacture or distribution of raw dietary ingredients, the manufacture of finished products, or solely the distribution and sale of finished products (manufactured by a separate firm) at the wholesale or retail level.

Consequently, the dietary supplement CGMP regulations may need to address the distinctive requirements of each of these segments of the industry in order to effectively ensure that dietary supplements and complimentary medicines are what they are represented to be and are safe for their intended use. In this effort, we suggest a limited number of licence holders so that the industry can conform in a limited amount of time.

Comments regarding this proposal.

Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.

Dated: May 6, 1998.

Prof. Peter Folb

 

Chairman - Medicines Control Council

Director : WHO : Collaborating Centre For Drug Policy