Our legal team’s focus on cosmetics, dietary supplements, and medical devices gives us the expertise to help clients navigate FDA and FTC issues. We advise a range of clients on FDA and FTC legal questions, including:
Our expertise includes products targeted to:
- Overall Health
- Weight Loss
We excel at helping clients make claims that pack as much marketing power as possible, without intruding on FDA and FTC legal boundaries.
Definition of Cosmetic
The FDA defines a cosmetic as an article 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 and the component parts of such an article. The term cosmetic includes 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.
Under the federal Food, Drug & Cosmetic Act, drugs, biologics and medical devices require premarket FDA approval.
Dietary supplements, and cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval, although the FDA may pursue enforcement action against products, firms or individuals that violate the law.
Cosmetics and Misbranding
Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the Food, Drug & Cosmetic Act, a cosmetic is considered misbranded if —
- The label contains any false or misleading information, or is false and misleading by failing to include all the required information.
- The label lacks required information.
- The required information is not sufficiently conspicuous and prominent.
- The packaging is misleading.
- There is improper packaging and labeling of color additives, and
- The packaging has deficiencies where the Poison Prevention Packaging Act requires special packaging.
FTC Legal Issues
While the FDA has primary jurisdiction over labeling, safety and purity of a given food, dietary supplement, medical device, or cosmetic, the Federal Trade Commission (FTC) enforces advertising and marketing regulation, to ensure that claims are truthful, not misleading and adequately substantiated. Thus, we address both FDA and FTC legal issues for our clients.
Legal Services – Cosmetics
Our scope of legal services includes:
- Defense of FDA Inspections, Investigations & Administrative Detentions
- Distributor Agreements
- Licensing Agreements
- Marketing Agent Agreements
- Sales Representative Agreements
- FDA Regulatory Compliance Advice
- FTC Regulatory Compliance Advice
- Guidance Regarding Product Substantiation (Clinical Studies, etc.)
- Labels and Labeling
- Response to FDA Warning Letters
- Advertising (Print and Online)
- Marketing Claims
- Retail Displays
- Testimonials and Endorsements
The claims made about a product, whether in advertising or labeling, can be the difference between whether the product is regulated by FDA as a drug, a cosmetic, or both. Contact our experienced attorneys for FDA legal guidance regarding your product.