Implementation of GMP’s for Cosmetics in a Changing Global Environment Training by 3V, Inc. & KPOPP Consulting, LLC


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  • FDA Authority Over Cosmetics
    March 3, 2005
    What does the law say about cosmetic safety and labeling?
    The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act1 (FD&C Act) and the Fair Packaging and Labeling Act2 (FPLA).
    The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action. Under the FD&C Act, a cosmetic is adulterated if--
    "it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" [with an exception made for hair dyes3];
    "it consists in whole or in part of any filthy putrid, or decomposed substance";
    "it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health";
    "its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health"; or
    except for hair dyes, "it is, or it bears or contains, a color additive4 which is unsafe within the meaning of section 721(a)" of the FD&C Act. (FD&C Act, sec. 601)
    Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if--
    "its labeling is false or misleading in any particular";
    its label does not include all required information;
    the required information is not adequately prominent and conspicuous;
    "its container is so made, formed, or filled as to be misleading";
    it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and
    "its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, sec. 602)
    In addition, under the authority of the FPLA, FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act.
    It is important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including FDA, to create and enforce regulations, but only as authorized under the law. A change in FDA's statutory authority over cosmetics would require Congress to change the law.
    Does FDA approve cosmetics before they go on the market?
    FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.
    Who is responsible for substantiating the safety of cosmetics?
    Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label:
    "Warning--The safety of this product has not been determined." (21 CFR 740.10)
    In addition, regulations prohibit or restrict the use of several ingredients5 in cosmetic products and require warning statements6 on the labels of certain types of cosmetics.
    In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.
    Can FDA order the recall of a hazardous cosmetic from the market?
    Recalls7 of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective. FDA categorizes a firm's action as a recall (as opposed to a market withdrawal) when it determines that the product hazard or defect represents a violation of the FD&C Act.
    FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request. Recalls are addressed in Title 21 of the Code of Federal Regulations (CFR), sections 7.40 through 7.59.
    What actions can FDA take against firms that market adulterated or misbranded cosmetics?
    FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Violative cosmetics may be subject to seizure. FDA also may initiate criminal action against a person violating the law.
    In addition, FDA works closely with the U.S. Customs and Border Protection8 to monitor imports. Under section 801(a) of the FD&C Act, imported cosmetics9 are subject to review by FDA at the time of entry through U.S. Customs. Products that do not comply with FDA laws and regulations are subject to refusal of admission into the United States. Violative products must be brought into compliance (if feasible), destroyed, or re-exported.
    FDA takes regulatory action based upon agency priorities, consistent with public health concerns and available resources.
    Can FDA inspect cosmetic manufacturers?
    FDA can and does inspect cosmetic manufacturing facilities10 to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
    Does FDA test cosmetics?
    The FD&C Act does not subject cosmetics to FDA premarket approval in order to be marketed legally. However, FDA collects samples for examination and analysis as part of its plant inspections, import inspections, and follow-up to complaints of adverse reactions. FDA may also conduct research on cosmetic products and ingredients to address safety concerns.
    The agency does not function as a private testing laboratory, and in order to avoid even the perception of conflict of interest, does not recommend private laboratories to consumers or manufacturers for sample analysis. Testing laboratories are listed in your telephone directory.
    Must cosmetic manufacturers register with FDA?
    Manufacturers are not required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA. However, companies are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA's Voluntary Cosmetic Registration Program11 (VCRP).
  • Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
    July 8, 2002
    The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.
    How does the law define a cosmetic?
    The Federal Food, Drug, and Cosmetic Act1 (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
    How does the law define a drug?
    The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].
    How can a product be both a cosmetic and a drug?
    Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.
    What about "cosmeceuticals"?
    The FD&C Act does not recognize any such category as "cosmeceuticals."2 A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.
    How is a product's intended use established?
    Intended use may be established in a number of ways. Among them are:
    Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.
    Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
    Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.
    This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.
    How are the laws and regulations different for cosmetics and drugs?
    The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. You should direct questions regarding laws and regulations for drugs to FDA's Center for Drug Evaluation and Research3 (CDER).
    How approval requirements are different
    FDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives4. Drugs, however, are subject to FDA approval. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either -
    Be the subject of an approved New Drug Application (NDA) [FD&C Act, sec. 505(a) and (b)], or
    Comply with the appropriate monograph, or rule, for an OTC drug.
    What do these terms mean?
    An NDA is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the U.S. FDA only approves an NDA after determining, for example, that the data are adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system and their 'switch' to OTC status is approved via the NDA system.
    FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of non-prescription drugs, such as what ingredients may be used and for what intended use. Among the many non-prescription drug categories covered by OTC monographs are -
    acne medications
    treatments for dandruff, seborrheic dermatitis, and psoriasis
    A note on "new drugs": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, no matter how ancient or "traditional" its use may be, once the agency has made a final determination on the status of an OTC drug product it must have an approved NDA or comply with the appropriate OTC monograph to be marketed legally in interstate commerce. Certain OTC drugs may remain on the market without NDA approval pending final regulations covering the appropriate class of drugs.
    Where to learn more about NDAs and OTC monographs: If you have questions about NDAs and OTC monographs, you should address them to CDER5.
    How good manufacturing practice requirements are different
    Good manufacturing practice (GMP) is an important factor in assuring that your cosmetic products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations6 (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].
    How registration requirements are different
    FDA maintains the Voluntary Cosmetic Registration Program7, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
    How labeling requirements are different
    A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients."
    And what if it's "soap"?
    Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because -- even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.
    How FDA defines "soap"
    Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when --
    The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
    The product is labeled, sold, and represented solely as soap [21 CFR 701.20].
    If a cleanser does not meet all of these criteria...
    If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:
    If a product --
    consists of detergents or
    primarily of alkali salts of fatty acids and
    is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
    it is regulated as a cosmetic.
    If a product --
    consists of detergents or
    primarily of alkali salts of fatty acids and
    is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
    it is regulated as a drug.
    If a product --
    is intended solely for cleansing the human body and
    has the characteristics consumers generally associate with soap,
    does not consist primarily of alkali salts of fatty acids,
    it may be identified in labeling as soap, but it is regulated as a cosmetic.
    February 24, 2000
    While the Federal Food, Drug, and Cosmetic Act1 (FD&C Act) does not recognize the term "cosmeceutical," the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits.
    The FD&C Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to a review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug.
    See also: Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)2 and Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics3.
  • Ch. 1 - Regulatory Organization
    Chapter 1
    1-1 - INTRODUCTION1  
  • February 9, 2006
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things,
    "The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded" [FD&C Act, sec. 301(a); 21 U.S.C. 331(a)].
    "The adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce" [FD&C Act, sec. 301(b); 21 U.S.C. 331(b)].
    "The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise“ [FD&C Act, sec. 301(c); 21 U.S.C. 331(c)].
    "The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded" [FD&C Act, sec. 301(k); 21 U.S.C. 331(k)].
    This means that nearly everyone involved in cosmetics in interstate commerce, such as manufacturers, packers, distributors, and retailers, is responsible for assuring that he or she is not dealing in products that are adulterated or misbranded, even if someone else caused the adulteration or misbranding in the first place. If you introduce it into interstate commerce or receive it in interstate commerce, you are responsible. The law applies to components and packaging as well as to finished products.
    The FD&C Act describes what constitutes interstate commerce, adulteration, and misbranding. It also authorizes FDA to take legal action if cosmetics are adulterated or misbranded. In addition, the Fair Packaging and Labeling Act (FPLA) requires specific label information. Violations of the FPLA result in misbranding.
    What does the FD&C Act mean by interstate commerce?
    Section 201(b) of the FD&C Act [21 U.S.C. 321(b)] tells what circumstances place a product in interstate commerce:
    "(1) commerce between any State or Territory and any place outside thereof, and
    (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."
    "Interstate commerce" applies to all steps in a product's manufacture, packaging, and distribution. It is very rare that a cosmetic product on the market is not in "interstate commerce" under the law. For example, at least some of your ingredients or packaging most likely originate from out of state, or even out of the country. Likewise, it is foreseeable that your products will leave the state. Although there are certain exemptions [21 CFR 701.9], factors such as these generally cause the requirements of the FD&C Act to apply to your products.
  • SEC. 601. [21 USC §361] Adulterated Cosmetics
    A cosmetic shall be deemed to be adulterated—  1
    (a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: ‘‘Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.’’, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term ‘‘hair dye’’ shall not include eyelash dyes or eyebrow dyes.
    (b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
    (c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
    (d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
    (e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a).
     1. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)", "(b)", etc.
  • 7. Synthetic musks can be divided into three major classes — aromatic nitro musks, polycyclic musk compounds, and macrocyclic musk compounds.[1] The first two groups have broad uses in industry ranging from cosmetics to detergents. However, the detection of the first two chemical groups in human and environmental samples as well as their carcinogenic properties initiated a public debate on the use of these compounds and a ban or reduction of their use in many regions of the world. Research indicates that these musks don’t break down in the environment, can accumulate in human bodies, are potential hormone disruptors and may break down the body’s defenses against other toxic chemical exposures. Macrocyclic musk compounds are expected to replace them since these compounds appear to be safer.
  • SEC. 602. [21 USC §362] Misbranded Cosmetics
    A cosmetic shall be deemed to be misbranded—
    (a) If its labeling is false or misleading in any particular.
    (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
    (c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
    (d) If its container is so made, formed, or filled as to be misleading.
    (e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a)).
    (f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.
  • Implementation of GMP’s for Cosmetics in a Changing Global Environment Training by 3V, Inc. & KPOPP Consulting, LLC

    1. 1. Implementation of GMP’s for Cosmetics in a Changing Global Environment Presented to the New England Chapter Society of Cosmetic Chemists April 5, 2012 by Joseph Albanese 3V, Inc. and Karl F. Popp, R. Ph. KPOPP Consulting, LLC
    2. 2. Course Goals • Provide an Overview of US, EU, and ASEAN GMP Regulations affecting Cosmetics • Discuss Quality Systems • Review Procedures for Writing, Issuance, maintenance and Implementation of SOPs • Show How GMPs affect Product Processing – Raw Materials – Manufacturing and Packaging Batch Records – Equipment Cleaning Labeling and Storage – QC Testing • Managing Water Systems • Auditing for Compliance • Introduce Process and Cleaning Validation
    3. 3. Why are there GMPs? • Responsibilities – Corporate – Personal – Legal • FDA • European Regulations • Association of Southeast Asian Nations • Importation • Export • Fraud • SOMEONE GOT HURT !
    4. 4. Short Story on GMPs • • • • • Prevent contamination Prevent mix ups and errors Instill process controls Insure product quality Save everyone money SAFETY
    5. 5. Basic Rule of Thumb • Whether imported, exported or made within the country, cosmetics MUST be in compliance with the provisions of the regulations of the country of sales, and may also need to be in compliance with the regulations with the country of manufacture.
    6. 6. Cosmetic GMP Regulations • US Cosmetic GMPs – FD&C Act [Sec. 301] prohibits introduction, or delivery for introduction, into interstate commerce cosmetics that are • adulterated [Sec. 601], or • misbranded [Sec. 602]. – FDA has authority to inspect firms, establishment, equipment, unfinished and finished materials, containers and labeling [Sec. 704]
    7. 7. Cosmetic GMP Regulations • EU Cosmetic GMPs • Guidelines aimed at cosmetics manufacturers in order to improve safety, offer organisational and practical advice on the management of the human, technical and administrative factors affecting product quality. • Describe the manufacturing conditions and management activities involved in the different stages of production, from the purchase of the raw materials to the dispatch of the packaged end-products. • Current Requirement Reference: ISO 22716
    8. 8. European Cosmetic Directive • Article 5.1 “Good Manufacturing Practice” requires that “Manufacturing of cosmetic products shall comply with good manufacturing practice…..” • Article 5.2. states that “Compliance to good manufacturing practice shall be presumed where manufacturing is in accordance with the relevant harmonized standard,…..” • The ISO standard 22716 (2007) ”Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices” has been approved an published in 2007 and is becoming more and more accepted at international level. • It is expected that this standard will become a harmonized standard soon after the publication of the new cosmetic regulation (2013) • Therefore compliance to this standard will guarantee compliance to Article 5 of the cosmetic regulation. 8
    9. 9. Cosmetic GMP Regulations • ASEAN Cosmetic GMPs – Driven by Article 8.1.c [ASEAN Cosmetic Directive] • Follows primarily EU activities • Guidelines intended as a general guideline for the manufacturers to develop its own internal quality management system and procedures • Goal: – “The final products must meet the quality standards appropriate to their intended use to insure consumer’s health and benefit”
    10. 10. What do the “Guidelines Cover” Comparison of Regulations US EU ASEAN X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Topic Introduction Quality System Personnel Training Premises Equipment Sanitation/Hygiene Production/Manufacturing Purchasing Quality Management Quality Control Documentation Out of Spec Result Handling Labeling Internal Audits Storage Contract Manufacturing and Analysis Complaints Subcontracted Manufacturing Sample Retention Recalls Shipping Traceability Glossary X X X X X X X X X X X X X X X X X X X X X
    11. 11. Comparison of GMPS US FDA, WHO & EU • Responsibility for Quality – FDA – the QC unit is responsible for quality – WHO & EU – define both separate and joint responsibilities for the QC unit and production management • Personnel Qualifications – FDA – education, knowledge, skills or experience needed for specific job functions are not defined – WHO & EU – provide such definitions & requirements • Production & Process Controls – FDA – focuses on levels of approval – ICH – focuses on stability requirements 11
    12. 12. Harmonization International Cooperation on Cosmetic Regulation (US, European Union, Canada, Japan) • • • • • • • Good manufacturing practices Ingredient labeling / INCI names Nanotechnology Market surveillance Authorized substances Animal testing and alternative methods Sunscreen regulations and test methods 12
    13. 13. Definition of cGMP “The minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.” - Title 21 Code of Federal Regulations (CFR), Part 210.1
    14. 14. What is “current” and “good”? • Feasible for manufacturers to implement • Not just for DRUGS • Contributes to ensuring the safety, quality, or purity of the drug product • The value of the contribution exceeds the cost or other burdens of implementation • It does not have to be the most prevalent practice in the industry 14
    15. 15. Does it apply to cosmetics too? 15
    16. 16. Yes, cosmetics too. “These regulations clearly apply to all drugs whether or not they are characterized as old drugs, new drugs, investigational drugs, or ingredients of drugs, devices or cosmetics.” SOURCE: Good Manufacturing Practices for Pharmaceuticals 4th Ed, Willig & Stoker, Preface pp III-IV. Sidney H. Willig - Drug Law Unit Temple University James R. Stoker - Legal Dept. Sterling Drug 16
    17. 17. FDA Definitions • Cosmetics - cleanse and beautify the body; not including soaps (alkali salts of fatty acids). DO NOT REQUIRE PRE-MARKET APPROVAL BY THE FDA. However, color additives must be preapproved! • Drugs – alter the structure or function of the body. Intended to diagnose, treat, care, mitigate or prevent disease. DO REQUIRE PRE-MARKET APPROVAL BY THE FDA. • Both – a.k.a. “OTC Drugs” shampoos that are also antidandruff, deodorants that are also antiperspirants, dentifrice with fluoride, creams & lotions with sunscreens, antibacterial cleansers 17
    18. 18. OTC Drug OTC Drug vs. Cosmetic • Pre-market approval or USP monograph required • Safety & efficacy must be cleared • Subject to cGMP • Must not be adulterated or misbranded • Establishments & products must be registered • No prescription required • Symptom relief Cosmetic • Pre-market approval not required • No pre-market clearance of product or ingredient claims, safety or efficacy • Must not be adulterated or misbranded • Establishment & product registration not mandatory • No prescription required • Adverse event reporting is not required (yet) • Cleansing, beautifying, or altering the appearance 18
    19. 19. FDA Focus • Office of Cosmetics & Colors (OCAC) / Center for Food Safety and Nutrition (CFSAN) (Dec 6, 2006) – – – – Microbial contamination Illegal color additive use Bovine Spongiform Encephalopathy (BSE) Bioterrorism/Counterterrorism (BT/CT) • Center for Drug Evaluation & Research (CDER) – Dermatology – OTC Products – Compliance 19
    20. 20. FDA Cosmetics Mission Statement “ . . . Protect the public health by ensuring that cosmetics are safe and properly labeled . . .” - Food and Drug Administration Modernization Act (FDAMA) of 1997, Sec. 406(b)(2)(D) 20
    21. 21. The Focus of the FDA’s cGMPs - Annual Product Reviews - Salvage / Returns - Consumer Complaint Reviews - Rejects - OOS / Failure Investigations - Change Control - Continuous Improvement - Reprocessing - Stability Failures - Quarantined Products - Validation - Training / Qualification of Employees 21
    22. 22. You’re not likely to fly under the radar screen • “Interstate commerce” means between any State, Territory or the District of Columbia. It applies to all steps in a product's manufacture, packaging, and distribution. • “Commercial distribution” means annual gross sales in excess of $1,000 for that product. 22
    23. 23. Cosmetic Safety, as per the FDA • Can not contain any of the restricted ingredients. • Cosmetic firms must substantiate the safety of their products before marketing them. • If safety is not substantiated the following warning must be on the label or the product is misbranded: – WARNING- The safety of this product has not been determined. • Product recalls of hazardous cosmetics is voluntary. – FDA works with the courts to remove adulterated and/or misbranded cosmetics from the market – Restraining orders, product seizure, criminal prosecution of firms and individuals are all possible. 23
    24. 24. Title 21, CFR for Cosmetic Products • • • • • • • • • • • 21 CFR PART 1 - General enforcement regulations 21 CFR Part 2 - General administrative rulings & decisions 21 CFR Part 20 - Public Information 21 CFR Part 250 - Requirements for drugs & cosmetics 21 CFR SUBCHAPTER G – COSMETICS 21 CFR PART 700 – GENERAL Subpart A – General Provisions Subpart B – Requirements for Specific Cosmetic Products 21 CFR PART 701 – COSMETIC LABELING, Subpart A – General Provisions Subpart B – Packaging Subpart C – Labeling of specific ingredients 21 CFR PART 710 – Voluntary registration of cosmetic product establishments 21 CFR PART 720 Voluntary filing of cosmetic product ingredients & cosmetic raw material composition statements 21 CFR PART 740 – Cosmetic Product Warning Statements 21 CFR PART 820 – Quality Systems regulations 24
    25. 25. Adulterated (Sec. 601) • Injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance, chemical contaminant or prohibited ingredient • It contains filth and/or pathogenic bacteria • It contains a non-permitted or in some instance noncertified, color additive • It is manufactured or held under unsanitary conditions whereby it may have become injurious to users or contaminated by filth 25
    26. 26. Prohibited Cosmetic Ingredients 1. Hexachlorophene (21 CFR 250.250) 2. Mercury Compounds (21 CFR 700.13) 3. Chlorofluorocarbon Propellants (21 CFR 700.23 and 2.125) 5. Acetyl ethyl tetramethyl tetralin (AETT) 6. 6-Methylcoumarin (6-MC) 7. Musk Ambrette 8. Nitrosamines 9. Dioxane 10. Certain cattle materials Organic dyes or pigments require pre-market approval and must be certified by the FDA before use. 26
    27. 27. Misbranded (Sec. 602) • Failure to comply with the Fair Packaging & Labeling Act of 1967 • Failure to comply with the Poison Prevention Packaging Act of 1970 • Failure to state prominently and conspicuously any information required by the FD&C Act • False or misleading labeling • Misleading container presentation or fill 27
    28. 28. Restricted Cosmetic Ingredients (permissible as unintentional contaminants) 1. 2. 3. 4. 5. Bithionol Halogenated Salicylanilides Chloroform Vinyl chloride Zirconium containing complexes in aerosol cosmetic products 6. Methylene chloride 28
    29. 29. Other FDA positions . . . • Natural – Not defined in FD&C Act or in FDA regulations for cosmetics – May be defined for other commodities as ‘minimal processing’, ‘semi-synthetic’, ‘nature-identical’, etc. • Organic – Not defined in FD&C Act or in FDA regulations for cosmetics – Defined by USDA for agricultural commodities & ingredients • Cosmeceutical – The FDA does not recognize this term which is analogous to Japan’s “quasi-drug” category. 29
    30. 30. GMP for Cosmetics “Although there are no good manufacturing practice (GMP) regulations for cosmetics, we do have Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.” /Cosmetics/GuidanceComplianceRegulatoryInformation/Complia nceEnforcement/ucm136455.htm 30
    31. 31. We are a “self-regulated” industry . . . Consumer Commitment Code (2007) •Cosmetic Ingredient Review Expert Panel •Voluntary Cosmetic Reporting Program •Report Adverse Experience to the FDA •Maintain Safety Information Summary REMEMBER While we may be “self-regulated” the FDA has ultimate authority over cosmetics too! 31