Cosmetics companies can make claims for their products, so long as mindful of the way FDA and FTC laws and regulations shape the marketing environment.
Our Focus on Cosmetics Companies’ Legal Needs
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
Cosmeceutical” and “nutraceutical” are industry names for products that present hybrid qualities—for example, a cosmetic or a dietary supplement with therapeutic properties.
However, the FDA does not regulate a product as a cosmeceutical or nutraceutical, per se.
Typically, we counsel clients to distinguish as to whether their product will be regulated as a:
- Dietary Supplement
- Drug (prescription (Rx) or OTC)
- Medical Device
- Medical Food
The FDA notes that if a product makes therapeutic claims (for example, a shampoo whose intended use is to treat psoriasis), then it may fall into multiple regulatory categories and have to meet the requirements of both (for example, cosmetic and drug).
In Are Some Cosmetics Promising Too Much, FDA gives very limited examples of claims cosmetics may make:
- Cleanses skin
- Enhances beauty
- Promotes attractiveness
- Alters appearance
Moisturizing has traditionally been considered a valid claim for a cosmetics product.
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.
FDA has severe penalties for misbranding. This is why claims review is to important.
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 for Cosmetics Companies
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.
Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.
Manufacturers of new dietary supplements, cosmetics, and nutraceuticals can find legal advice about labeling and FDA-compliant claims by following these guidelines.
The federal Food Drug & Cosmetic Act distinguishes medical devices from cosmetics, though I’ve come across a letter debating the FDA’s warning that a certain cosmetic could constitute a “medical device.”
Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.
5 Ways Cosmetic Product Companies Can Comply with FDA Labeling Requirements & Help Avoid FDA Enforcement.
Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements
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