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Section: Testing

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FDA Reviews Sunscreen Active

The Food and Drug Administration(FDA) has requested safety and efficacy data for the sunscreen active ingredient diethylhexyl butamido triazone in concentrations...

US FDA Pushes Sunscreen Reform on Three Fronts

The U.S. Food and Drug Administration has announced three new efforts to advance its framework for sun protection products including Maximal Usage Trials (MUsT)—just ahead of summer vacation and in line with #DontFryDay.

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Why the FDA's 'Sunscreens in the Bloodstream' Study is Flawed

A recent study published in the Journal of the American Medical Association tested the potential systemic absorption of certain sunscreens. Results identified their presence in subjects' bloodstreams; however, as industry expert David Steinberg explains, the study is misleading and fails to consider crucial variables.

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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.

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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.

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.

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FDA Issues Draft Guidance for Topical Drugs

Contact dermatitis from topical drugs and human safety are the topics in a recently issued guidance document made available by the FDA. Comments are sought through May 8, 2020.

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FDA Alert: New J&J Baby Powder Recall

According to the FDA, a test sample from one lot was found to contain chrysotile fibers, a type of asbestos. As such, Oct. 18, 2019, Johnson & Johnson voluntarily recalled the product.

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Antibacterial Soap? You Can Skip It, Says FDA

The FDA is issuing a final rule under which OTC consumer antiseptic wash products containing the majority of the antibacterial active ingredients—including triclosan and triclocarban—will no longer be able to be marketed.

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FDA Sets Regulatory Framework for Regenerative Biological Therapies

It's a sign of the times when technology and innovation hit a point where the U.S. Food and Drug Administration must stop and write new rules to ensure consumer safety. That time, with respect to regenerative biological therapies, is now.

The FDA reminded consumers to check its blacklist of hand sanitizers they should not use due to methanol content, insufficient active ingredient or false and misleading/unproven claims.

FDA on Hand Sanitizers, Topical Irritation Testing and Biosimilars

Recent FDA activities include education for consumers on hand sanitizers and biosimilars, and guidance for testing the irritation/sensitization potential of topicals in relation to abbreviated new drug applications. Following is a roundup.

The FDA has issued 15 warning letters to companies selling products containing CBD.

U.S. FDA Issues 15 Warning Letters Over CBD Products

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe," said FDA principal deputy commissioner Amy Abernethy, M.D., Ph.D.

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What Dermatologists, FDA Say about Halloween Makeup

Spooky makeup fills novelty shops this time of year, but what did dermatologists and other experts have to say about safety and ingredients?

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[updated] FDA Oversight Becomes Closer to Reality for US Cosmetics

According to the bill's authors, it is supported by the leading cosmetic manufacturers and would give the FDA unprecedented authority. Editor's note: This report now includes CIR commentary.

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FDA Flags Eskbiochem Hand Sanitizers for Possible Methanol Content

The U.S. Food and Drug Administration has issued a warning statement to consumers over the use of Eskbiochem's hand sanitizers, which may contain methanol, i.e., wood alcohol.

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FDA Clarifies Executive Summary on Talc is Solely to Solicit Data

In response to concerns that the FDA's Executive Summary on talc could be interpreted as official recommendations, the agency clarified this summary is solely intended to solicit scientific information.

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Methanol Content and How to Test for it: FDA Guidance

The U.S. Food and Drug Administration has outlined a policy for companies to test alcohol (ethanol) or isopropyl alcohol for hazardous methanol content prior to their use in hand sanitizer products.

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FDA Cautions: Hair-smoothing Products Can Release Formaldehyde

The U.S. Food and Drug Administration recently released a statement warning users of the potential for hair-straightening products to release formaldehyde gas, a known carcinogen, during heat treatments.

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