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Manufacturing and Branding Cosmetics - 5 Best Practices to Follow for Regulatory Compliance


    Adhere to regulations governing the manufacture and branding of cosmetics to ensure regulatory compliance and avoid FDA Warning Letters

    In recent years, cosmetics companies have been increasingly pulled up by the FDA for failing to follow regulations, especially those governing manufacturing and branding of products. Companies big and large have been sent Warning Letters for making scientifically unproven claims, adulterating their products, microbial contamination at manufacturing facilities and more. This article puts together five best practices that can help cosmetics manufacturers address these issues and others in order to avoid regulatory enforcement actions and worse.

    How are Cosmetics Regulated in the US?

    Cosmetics manufacturers in the US are primarily expected to adhere to two regulations enforced by the FDA - the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

    The FD&C Act's provisions regarding cosmetics relate to adulteration or misbranding while the FPLA deals with labeling and ingredient declarations.

    The FDA inspects cosmetic manufacturing facilities to assure that cosmetic product safety and also to determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.

    Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives.

    Federal Food, Drug, and Cosmetic Act (FD&C Act) Requirement

    The FD&C Act prohibits the sale of adulterated or misbranded cosmetics. Under the Act's provisions, a cosmetic is considered to be adulterated if:

    • It contains any poisonous or deleterious substance which may injure users under the conditions of use prescribed in the (hair dyes are exempted from this)
    • It consists of even small quantities of filthy, putrid or decomposed substances
    • It is prepared, packed or store in unsanitary conditions
    • Its packaging contains poisonous or deleterious substances that may affect the health of the user
    • It contains unsafe color additives (hair dyes are exempted from this)

    Manufacturers who violate any of the above requirements will face regulatory action.

    Fair Packaging and Labeling Act (FPLA) Requirements

    Cosmetics that are improperly labeled or packaged will be considered misbranded under the FPLA's provisions. Specifically, a cosmetic product is considered to be misbranded if:

    • Its label is false or misleading
    • Its label does not include all the required information
    • The label's required information is not adequately prominent and conspicuous
    • Its packaging is formed or filled or made to be misleading
    • It is a color additive that violated provisions of the FD&C Act
    • Its packaging and labeling violate the Poison Prevention Packaging Act of 1970

    The FDA also requires manufacturers to ensure they comply with the FPLA by making an ingredient declaration through appropriate labeling. This should be done so that consumers can make informed decisions when buying a product.

    Cosmetics Recalls, Safety and Testing

    Recalls

    The FDA itself does not recall cosmetics that violate regulatory requirements or are found to be unsafe to consumers - cosmetics manufacturers are expected to do this. The 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.

    The FDA monitors 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 the agency's written request.

    Product Safety

    When it comes to safety, manufacturers are expected to substantiate the safety of their products and ingredients before marketing them.

    A product will be considered misbranded if the manufacturer has not taken adequate steps to substantiate the safety of a product. If the safety of a product has not been determined, then manufacturers are required by law to display the following warning prominently on the product packaging:

    "Warning - The safety of this product has not been determined."

    Testing

    The FDA collects samples for examination and analysis as part of its plant inspections, import inspections, and follow-up to complaints of adverse reactions.

    The agency can also research on cosmetic products and ingredients to address safety concerns.

    The Cost of Non-Compliance for Cosmetics Manufacturers

    The FDA regularly sends warning letters to cosmetics manufacturers who violated the FD&C Act and FPLA requirements. Those manufacturers who do not take corrective action can be fined heavily or have their products seized/ banned from the market. Overall, non-compliance and the FDA imposing penalties on a company for these regulatory violations can lead to a drop in customer confidence in the safety and efficacy of the product in question. An organization's reputation and bottom line can be badly affected by FDA enforcement actions.

    Here are some examples of warning letters:

    The above shows that when it comes to manufacturing cosmetics, companies have to ensure they comply with the FDA's regulations or face the risk of Warning Letters and worse.

    5 Best Practices to Ensure Compliance When Manufacturing Cosmetics

    To ensure they are in compliance with the FDA's regulatory requirements, cosmetics manufacturers should follow the below best practices:

    1. Determine if the product is a cosmetic or drug:
    2. It is very important for manufacturers to determine if their product is a cosmetic or a drug as these products have very different regulatory requirements.

      The FD&C Act defines a cosmetic by its intended use. Cosmetics are products that can 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." Products that would be considered cosmetics include:

      • skin moisturizers,
      • perfumes,
      • lipsticks,
      • fingernail polishes,
      • eye and facial makeup preparations,
      • cleansing shampoos,
      • permanent waves,
      • hair colors, and
      • deodorants, as well as any substance intended for use as a component of a cosmetic product

      A drug, however, is an article that is "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".

      So, the product would be determined to be a drug or cosmetic depending on its intended use. Intended use can be determined in the following ways:

      • 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, increase or decrease the production of melanin (pigment) in the skin, or regenerate 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 cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is a fluoride in toothpaste.
    3. Ensure cosmetics are not adulterated
    4. To ensure that their cosmetics are not adulterated, manufacturers should follow Good Manufacturing Practices, especially focusing on the following:

      Facilities

      • The space where the cosmetic is being manufactured should be sanitary
      • Proper cleaning procedures should be followed and maintained
      • There should be good lighting in all manufacturing areas
      • Proper, clean and sanitary water supply should be available
      • Washing facilities should also be available

      Equipment

      • Production equipment used for the manufacture of cosmetics should be of the right design
      • Equipment should be well-maintained and regularly cleaned and sanitized

      Personnel

      • All personnel should be trained properly
      • Correct clothing should be worn in the facility
      • Food or drink should not be consumed in the manufacturing facility

      Raw Materials

      • These should be stored properly and carefully to avoid mix-ups and contamination
      • They should be stored off the floor
      • Samples should be regularly tested for contaminants and results documented

      Training in GMPs should be provided to all personnel. The training must be documented and personnel should be retrained annually or when necessary if there are changes to GMPs.

      Standard Operating Procedures must be established and followed.

    5. Brand cosmetics properly
    6. To avoid branding violations, manufacturers should strictly follow the FDA's labeling requirements relating to cosmetics.

      Principal Display Panel (PDP)

      The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale, must:

      • state the name of the product,
      • identify by descriptive name or illustration the nature or use of the product, and
      • bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of:
        • weight,
        • measure,
        • numerical count, or
        • a combination of numerical count and weight or measure
      • The declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container as prescribed by regulation.
      • The net quantity of contents statement of a solid, semisolid or viscous cosmetic must be in terms of the avoirdupois pound and ounce, and a statement of liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the quart, pint, and fluid ounce subdivisions thereof.
      • If the net quantity of contents is one pound or one pint or more, it must be expressed in ounces, followed in parenthesis () by a declaration of the largest whole units (i.e., pounds and ounces or quarts and pints and ounces).
      • The net quantity of contents may additionally be stated in terms of the metric system of weights or measures.

      Information Panel

      • The name and place of business of the firm marketing the product must be stated on an information panel of the label
      • The address must state the street address, city, state, and zip code.
      • If a firm is listed in a current city or telephone directory, the street address may be omitted.
      • If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ......" or "Distributed by ......" or similar, appropriate wording.
      • The Tariff Act of 1930 requires that all imported articles state on the label the English name of the country of origin.

      Declaration of Ingredients

      Cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration:

      • The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase.
      • It may appear on any information panel of the package, i.e., the folding carton, box wrapping if the immediate container is so packaged, and may also appear on a firmly affixed tag, tape or card.
      • The letters must not be less than 1/16 of an inch in height
      • If the total package surface available to bear labeling is less than 12 square inches, the letters must not be less than 1/32 of an inch in height
      • Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches

      The ingredients must be declared in descending order of predominance:

      • Color additives and ingredients present at one percent or less may be declared without regard for predominance.
      • The ingredients must be identified by the names established or adopted by regulation
      • Those ingredients accepted by the FDA as exempt from public disclosure may be stated as "and other ingredients"
      • Cosmetics which are also drugs must first identify the drug ingredient(s) as "active ingredient(s)" before listing the cosmetic ingredients

      All label statements should be in English and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase.

      Label Warnings

      Cosmetics that may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. The statements must be prominent and conspicuous.

    7. Establish a comprehensive product surveillance program
    8. Cosmetics manufacturers should establish a comprehensive product surveillance program to avoid regulatory non-compliance.

      This program should

      • interface with customer complaints that the company receives once the product is in the marketplace
      • collect monitor and report adverse events relating to the company products
      • establish Standard Operating Procedures or SOPs that personnel should follow
      • Report any significant event internally to management or externally to relevant stakeholders

      In order to ensure the program works effectively, an organization can:

      • Identify staff to take on this program and its responsibilities
      • Develop data collection forms and file retention systems
      • Train employees on the reporting mechanism (who to report to, what cases to report and how to report them)
      • Set up a management team that can evaluate and address findings
      • Appoint a medical reviewer for assessing adverse events
      • Perform a root cause analysis and corrective actions if any
      • Report cases that are a risk to consumer health
      • Prepare staff for FDA or State Department of Health inspection

    9. Check ingredients are not on the prohibited and restricted list
    10. The FDA has clear guidelines on what it considers to be prohibited and restricted ingredients. Manufacturers should ensure that the ingredients they use are not prohibited. Examples of prohibited ingredients include:

      • Bithionol: The use of bithionol is prohibited because it may cause photo-contact sensitization
      • Chlorofluorocarbon propellants: The use of chlorofluorocarbon propellants (fully halogenated chlorofluoroalkanes) in cosmetic aerosol products intended for domestic consumption is prohibited
      • Chloroform: The use of chloroform in cosmetic products is prohibited because of its animal carcinogenicity and likely hazard to human health. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient
      • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide): These are prohibited in cosmetic products because they may cause photo contact sensitization
      • Methylene chloride: The use of this substance in cosmetic products is prohibited because of its animal carcinogenicity and likely hazard to human health
      • Vinyl chloride: The use of vinyl chloride is prohibited as an ingredient of aerosol products, because of its carcinogenicity
      • Zirconium-containing complexes: The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs, including the formation of granulomas
      • Prohibited cattle materials: To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials.

      Manufacturers should also remember that color additives are strictly regulated. Except in the case of coal-tar hair dyes, failure to meet U.S. color additive requirements will cause the cosmetic to be adulterated. The most common reason for imported cosmetics to be detained is because they violate color additive rules.

    Adopt GMPs and Avoid Misleading Claims to Ensure FDA Compliance

    The FDA, as has been explained earlier in this article, doesn't yet require cosmetics manufacturers to seek pre-market approval for new products. The agency has adopted a mostly hands-off approach when it comes to policing manufacturers. However, this adds more pressure on the manufacturer to ensure that it complies with regulatory requirements. Since the success or failure of a cosmetic product depends so much on consumer perception (this includes factors such as safety and efficacy), it is important for companies to take full responsibility in making products that are safe and effective. Testing of raw materials and products should be carried out regularly to prevent contamination and claims made on labels should not be false or misleading. The bad news about product safety can damage the faith of consumers in a company's product, leading to an erosion of trust. Following the best practices discussed in this article can help cosmetics companies avoid such situations.

    How can compliance training help?

    The areas highlighted above are just a small part of the wide range of practices and processes that ensure cosmetics manufacturers comply with regulations. Subjects such as cosmetics compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. Our courses are available as live webinars, training recordings and seminars. We also offer customized training courses developed in conjunction with organizations that wish to train large groups of their employees.

    If you need customized training courses or specialist GRC consulting services, please contact us through email [email protected] or call us at this toll-free number:
    +1-888-717-2436.