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Section: Formulas/Products

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FDA Pushes Higher Limits, New Labeling and More Data for Sunscreens

Broad spectrum sunscreens are critical for preventing skin cancer and UV damage, yet many of their essential requirements have not been updated in years. This was the driver for new sunscreen regulatory rules proposed by the FDA.

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Sunscreen Absorption Makes Waves Again, FDA Shifts Toward Test Sample Selection

Questions of sunscreen absorption made waves once again in a recent report in the Wall Street Journal. Prior reports found no cause for concern while more recently, the FDA turned its focus to the selection method for sunscreens used in absorption tests.

FDA Publishes Opinion on Two Sunscreen TEAs and Is Urged for More Action by PASS

The end of February was busy for the U.S. Food and Drug Administration (FDA), which published two letters on the Time and Extent Applications (TEAs) for diethylhexyl butamido triazone (Uvasorb HEB) and amiloxate (Neo Heliopan E 1000), finding insufficient scientific evidence to claim either as generally recognized as safe and effective (GRASE) and denying their addition to the OTC Sunscreen Monograph.

Sunscreen Innovation Act Passes: What Does it Mean?

The Public Access to SunScreens (PASS) Coalition applauded the U.S. Senate's passage of the Sunscreen Innovation Act (S. 2141). While the Act aims to streamline the approval process for new sunscreen actives, will it? Industry expert David Steinberg gives his take.

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FDA Weighs in on Holographic Cosmetics

Holographic, iridescent and other special effect color additives have been allowed to shine in recent consumer trends. Click through for the U.S. Food and Drug Administration's take on how these additives are regulated.

FDA Hones in on Cosmetic Claims

The FDA issued five such letters since November 2014, the most recent being sent to StriVectin. Following those letters, the FDA has also issued a document that clarifies cosmetic versus drug claims for the consumer to highlight what cosmetic companies are able to say.

FDA Issues New Guidances on Nanotechnology

The US Food and Drug Administration has issued two new draft guidances on the use of nanotechnology by the cosmetics and foods industries.

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U.S. FDA Hand Sanitizer Solutions Explained

The U.S. Food and Drug Administration has liberalized the compounding of alcohol-based hand sanitizers such that any registered compounder can create these products as long as they follow the published formulas and guidelines. This article clears up the math on what these guidelines allow.

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FDA Cracks Down on Skin Lighteners

Skin whitening products walk the line between cosmetics and drugs, and often carry dangerous side effects. Flawless Beauty's injectable whitening products were struck down by a federal judge, putting lightening products under the lens.

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US FDA Releases Report on Color Additives

The U.S. Food and Drug Administration has released is first quarter report for 2019 on certified color additives.

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FDA Updates CFSAN Education Resource Library

Designed for personal and professional use, the library covers cosmetic safety, dietary supplements, food safety, nutrition and industry information such as food defense.

New Black Pigment Approved By FDA

D&C Black No. 3, or "bone black," has been approved by the US Food and Drug Administration (FDA) for formulation into eye shadow, eyeliner, mascara and face powder.

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Will CBD Cosmetics Face Greater FDA Scrutiny?

As the demand for CBD products continue to grow in 2020, so will the U.S. Food and Drug Administration (FDA) crackdown on their regulation. As explained in this report, the FDA plans to continue investing in regulations for a wider spectrum of CBD-containing cosmetics and foods.

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FDA Discusses 'Natural' in Food, Beverage Labeling

The U.S. Food and Drug Administration is finally talking about it: the word natural. Will this discussion move to cosmetics, next?

Prescription Polymer Nail Treatment Approved by the FDA

The U.S. Food and Drug Administration (FDA) has approved a prescription polymer treatment for brittle nail symdrome (nail dystrophy).

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VIDEO: 2 Questions on the FDA's Triclosan Ruling

The FDA's ruling on triclosan raises two questions, which David C. Steinberg describe in this fourth video in our series. However, he concedes that fighting the ruling is like "doubling down on an already-lost bet."

FDA Issues Final Guidance on Nanomaterials

On June 26, 2014, The U.S. Food and Drug Administration (FDA) issued Final Guidance for Industry: Safety of Nanomaterials in Cosmetics, a final guidance document addressing the use of nanotechnology in cosmetics.

Olumiant is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation, thereby, treating patients with alopecia areata.

FDA Approves First Systemic Alopecia Areata Treatment

Olumiant is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation to thereby treat patients with alopecia areata.

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