KKB has expertise in all aspects of labeling for cosmetics (including cosmetic devices). We advise on the proper ingredient identification, warnings, country of origin labeling, and other labeling requirements. We assist companies in developing appropriate cosmetic claims in light of rules governing drugs and taking into consideration historical practice for cosmetic vs. drug claims in the United States.
KKB has extensive advertising law experience relating to cosmetic claims. We regularly interpret federal and state advertising law – as well as the decisions of advertising self-regulatory bodies – in order to support client’s claims with appropriate wording and substantiation. We frequently defend such claims in cases before the FTC, state attorneys general, federal courts and self-regulatory bodies (such as the National Advertising Division of the Council of Better Business Bureaus). In particular, we are familiar with recent litigation against organic claims for personal care products, as well as claims under state unfair trade practice laws, and can assist clients in crafting claims to help reduce the risk of liability.
KKB advises clients on enforcement-related issues – for example: we advise on how to respond to FDA inspectors’ requests, FDA-483 observations, and Warning Letters. We also have extensive experience responding to more significant enforcement actions, including FDA actions for seizure, injunction, criminal prosecution, and all other FDA enforcement authorities.
KKB advises on the legality of cosmetic ingredients, including FDA and state law requirements. We have worked together with scientific experts to substantiate the safety of cosmetic ingredients, and also advise on state law reporting requirements such as the California Safe Cosmetics Act.
KKB assists clients in drafting agreements relating to regulatory issues, such as guarantees, labeling agreements (for exemption from labeling requirements for foods to be further manufactured), agreements for studies of new ingredients and claims, etc. We assist business planners in evaluating the investment needed to support new products, ingredients and claims. We also conduct due diligence reviews of food companies and products that are being considered for acquisition.