Since 2015, an increasing number of cosmetic companies have come under the harsh scrutiny of the US Food and Drug Administration (FDA) for reasons ranging from “misbranding” due to drug like claims to “adulteration” by contamination. The FDA’s increased focus on cosmetic companies and cosmetic products is seen in the recent uptick in warning letters, as well as the upsurge in detentions of imported cosmetic products.
Under the federal Food, Drug, Cosmetic Act (FDCA), cosmetics include any article “intended to by rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance.” In other words, cosmetic products are not intended to treat, prevent, or mitigate a disease or its symptoms, or affect structure or function of the skin — such claims would cause a product to be classified as a “drug” under the FDCA.
From 2015 to the present, FDA has issued several warning letters to cosmetic companies citing claims commonly seen across the cosmetic industry, such as:
- repairs damaged skin;
- reduce visible redness;
- treat dark spots and discolorations;
- boosts/stimulates collagen production;
- more tightening, lifting; and
- stimulate/increase circulation; among others.
In each case, the FDA finds that marketing a product with these or similar claims causes the product to be an unapproved new drug.
It is illegal to introduce into interstate commerce, a cosmetic product that is “adulterated”, or in other words, a cosmetic that “contains a poisonous or deleterious substance that may render the product injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual”. Such a “poisonous or deleterious substance” may include microbial contamination. From 2015 to the present, FDA issued 2 Warning Letters and an Untitled Letter to firms citing cosmetic products as adulterated due to microbial contamination.
Companies receiving an FDA Warning Letter must act fast, as the Agency only allows 15 working days to submit a response. Cosmetic companies facing mislabeling charges, must at the very least design new labels for all cosmetic products bearing drug claims, and change all marketing materials to remove every claim that causes their products to be unapproved “new drugs”. This can be particularly challenging in a highly competitive market where products are labeled with very similar claims, and every cosmetic product is struggling to stand out from the rest. Thus, it is imperative for cosmetic companies to act fast and seek professional help once the need is identified. Cosmetic companies facing adulteration charges face the much greater challenge of identifying the source of contamination and working to correct the existing deficiency, while implementing the necessary controls to prevent future instances of adulteration. These internal investigations can be complex and usually uncover other weaknesses within the firm. Again, cosmetic companies must work fast in order to respond to the FDA, and seek professional help once the need is identified.
Cosmetics offered for import must comply with the rules and regulations enforced by the FDA if they are offered for “consumption” in the U.S. If it appears that an imported cosmetic product may be noncompliant, FDA will issue a Notice of Action (NOA) detaining the product until the importer can establish, through evidence, that the cosmetic is in fact compliant. The most common reasons for the refusal of cosmetic products include:
- cosmetics are subject to an Import Alert;
- cosmetics are adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards;
- cosmetics are misbranded, meaning the labels contain drug claims, false or misleading information, are missing required information or labels are in a foreign language;
- cosmetics are manufactured under unsanitary conditions; and
- cosmetics contain prohibited color additives or lack batch certification; among others.
The number of cosmetic shipments detained by the FDA has increased over the years, many of which have now been placed on Import Alert, meaning that all future imports will be automatically detained until compliance can be established by the importer.
Future of Cosmetic Regulation
Some in Congress have also identified the need to strengthen the regulation of cosmetics, leading to the introduction of the Personal Care Products Safety Act (S. 1014), which, if enacted, would require cosmetic companies to register their facilities with the FDA, submit ingredient statements, and require FDA to review at least five new ingredients each year, while giving the FDA power to suspend facility registrations and prohibit distribution of violative cosmetic products.
Amid increased enforcement, cosmetic manufacturers, importers and distributors alike are advised to review their operations and take preventive measures now to avoid costly business interruptions. Cautious cosmetic companies should consider:
- analyzing all cosmetic product labels, websites and advertising to eliminate any possible drug claim or other misbranding;
- reviewing cosmetic manufacturing procedures to identify critical control points where adulteration is likely and control measures must be implemented; and
- anticipating increased import scrutiny.
Cosmetic companies facing enforcement action, or new companies getting into the cosmetic industry can benefit from working with an experienced FDA compliance attorney. Ann Marie Gaitan, Esq. regularly counsels cosmetic companies to establish compliant strategies that address existing problems and/or prevent regulatory deficiencies in the future. Mrs. Gaitan can be reached via e-mail at firstname.lastname@example.org or via telephone at 786.440.8115.