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Section: Regulations > Claims/Labeling

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FDA Proposes Labeling Rule for Color Additives [Feb. 2, 2006]

The U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register requiring the declaration of carmine and cochineal extract...

FDA Cracks Down on Medicinal Claims Regarding Bee By-products

The US Food and Drug Administration (FDA) cracked down on Wisconsin-based Beehive Botanicals Inc. after the company did not comply with requests to remove and change misbranded and unapproved claims from its Web site and labels.

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Nature Essence Small Molecule Co. Pinged by FDA Warning Letter

In addition to several food and beverage violations, the U.S. FDA cited adulterated cosmetics and new drug claims in its warning letter to the company.

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FDA Warns 1,500 New Sanitizer Makers: Follow the Rules

Safety and fraudulent claims are new concerns in the hand sanitizer market. Since the U.S. Food and Drug Administration (FDA) eased restrictions, some 1,500 new hand sanitizer manufacturers have registered to help; but many are not following the FDA's policy.

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FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls

Sanitizer warning letters and "hotlist" additions, plus microbe-related recalls are among the latest cosmetic-relevant updates from the U.S. Food and Drug Administration.

Advocacy Groups File Suit Against the FDA Over Nanotechnology Regulation

A coalition of six consumer safety and environmental groups is suing the US Food and Drug Administration (FDA) over its lack of nanotechnology regulation, specifically for sunscreen.

FDA Closes Negotiations with ICMAD and PCPC, Prompting Industry Response

On Mar. 6, 2014, Michael Taylor, on behalf of th The U.S. Food and Drug Administration (FDA), responded to the Proposed Draft Legislation by the Personal Care Product's Council (PCPC) and the Independent Cosmetics Manufacturers and Distributors (ICMAD), effectively finding no common ground between the three and closing the negotiation.

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FDA Warning Expands: More Hand Sanitizer Recalls Due to Methanol

The FDA has issued yet another warning to consumers to not use given hand sanitizer brands due to reports of the presence of the toxic and possibly deadly substance methanol.

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FDA Flags 13 More Sanitizers, Issues One Warning for Methanol Content

Methanol content or possible associations therewith account for 12 of the 13 latest additions by the U.S. Food and Drug Administration (FDA) to its "do not use" hand sanitizer list, along with one warning letter.

Product safety is paramount for fast-moving consumer goods such as cosmetics and personal care products. Recent recalls and class action suits highlight this fact.

Benzene, Methanol and Lead Headline Recent Class Actions and FDA Alerts

Methanol in hand sanitizers and lead in a baby skin care are cited in the latest U.S. Food and Drug Administration recall notices, while benzene content in dry shampoo and spray sunscreens persists among class action suits. Following is a roundup.

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U.S. FDA Red Flags Careful Cents, LLC for COVID-19 Claims

Careful Cents, LLC, is marketing essential oils that, according to the U.S. FDA, are misbranded drugs based on their claims. The agency issued a warning letter highlighting examples including immunity-boosting and antiviral effects, and positioned to address COVID-19.

L'Oréal Receives A Warning Letter From the FDA for Drug Claims

The US Food and Drug Administration (FDA) has issued a warning letter to L'Oréal for gene, stem cell and skin regeneration claims associated with Lancôme products.

FDA Warns Consumers About Side Effects from Topical Acne Actives

The U.S. Food and Drug Administration has issued a warning to consumers that over-the-counter (OTC) acne products containing benzoyl peroxide and salicylic acid can cause severe irritation or severe allergic reactions in rare instances.

One guideline is to include quantitative information from control groups; specifically, companies should fully describe the comparator used.

FDA Finalizes Guidance on DTC Drug, Biologicals Promotional Labeling

While cosmetics are not drugs, the industry could take inspiration from the U.S. Food and Drug Administration's (FDA's) guidance from the Office of Prescription Drug Promotion on labeling direct-to-consumer (DTC) drugs and biological products.

The inner packaging of a serum and product kit containing said serum listed SPF when the product has no SPF.

FDA Flags Color Additive, SPF and Contaminant Offenses, Urges 'Recall Readiness'

In recent months, the U.S. Food and Drug Administration (FDA) reported six voluntary recalls for an impermissible color additive, mislabeled SPF and several contaminants. It also urged companies to be "recall ready" and provided final guidance to do so.

While the cosmetics industry is not FDA-regulated, it often follows or adopts labeling and ideas from foods that are familiar to consumers. Could this be the next clean beauty?

The Next 'Clean' Beauty? FDA to Research 'Healthy' Food Claims, Labeling

The U.S. Food and Drug Administration (FDA) announced plans to research and identify rules for claims that foods and beverages contain "healthy" nutrients. Could this be the next "clean" beauty?

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Is Your Microbiology Lab FDA-compliant? Part I: Personnel, Facilities and Equipment

This two-part article provides an overview of areas relevant to the U.S. Food and Drug Administration’s (FDA’s) inspection of cosmetic microbiology laboratories. Part II will appear in our July 2018 edition.

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Pick and Choose—Balancing Sunscreen Benefits: Sun Protection or Vitamin D?

It’s well-known that over-exposure to UV light is harmful to the body, yet it is vital for production of essential vitamin D. Understanding the balance between the benefits of sun protection and vitamin D synthesis is not yet well understood.

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