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Regulation and Law

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FDA's OTC Antiseptic Rulemaking Has EWG Eyeing Triclosan In Cosmetics

Triclosan eventually may be eliminated entirely from OTC antiseptic drug products through FDA rulemaking, but it's still used in Colgate Total toothpastes to combat gingivitis and in cosmetics where it functions as a preservative. In a newly published paper, the Environmental Working Group and 200 international scientists and medical professionals express concern about the ingredient's use in those categories as well.

Cosmetic Ingredients Regulation Consumer

Soap Maker Warned As FDA's Cosmetics Enforcement Activity Picks Up

FDA has issued three warning letters to cosmetic product marketers over the past month. The agency cites Soapwalla for violative claims on bar soaps, while Star Health & Beauty's purported cosmetics and dietary supplements are not only unapproved drugs, but also adulterated in some cases due to GMP violations.

Regulation FDA Consumer

Both Sildenafil And Tadalafil Found In Spiked Supplements

FDA finds products promoted for sexual enhancement and with brands such as "Man of Steel" and "Royal Master" contain one or both of tadalafil or sildenafil, active ingredients in prescription drugs indicated for ED.

Dietary Supplements Regulation Safety
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Regulation

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Latest From Regulation

PharmaTech Recalls Highlight Supplement GMP Diligence For Marketers – CRN

PharmaTech customers recall liquid supplements, including products indicated for children, after CDC informs FDA that an antibiotic-resistant pathogen was found in a PharmaTech Rx drug. CRN says the recall should remind supplement firms about tracking supply chains and auditing contract manufacturers.

Dietary Supplements Recalls

APS Biogroup Warned On Parent Firm’s Children’s DiaResQ Branding

An FDA warning letter says during an inspection at Phoenix firm APS Biogroup’s facility in February, ORA Denver district officials found violative claims in addition to branding problems.

Dietary Supplements Regulation

MusclePharm Trims Loss, Vitamin Shoppe Stretches Spark: Health And Wellness Industry News

Age group clear in UK follow-on formula ad; MusclePharm trims loss; Kill Cliff alive with investment; and more news in brief.

Dietary Supplements Advertising, Marketing & Sales

‘Old’ Ingredient List On FDA Table Could Spur New Supplement Launches

CFSAN schedules a public meeting on developing a list of dietary ingredients available in the food supply before Congress in 1994 passed DSHEA. CRN expects the meeting to lead an “official safe harbor list” of eligible ingredients, but not directly to a final NDI notifications guidance.

Dietary Supplements Regulation

FDA Warning Letter Prompts Be Natural Organics To Revise Web Claims

The agency highlights claims for nine Be Natural Organics products – including statements about collagen production, cellular regeneration, hyperpigmentation reduction and eczema and acne treatment – in its recent warning letter to the company.

FDA Regulation

Anti-Acne Toothpaste? FDA Warns VMV Hypoallergenics Maker For Claims Violations

The non-GRASE status of VHV Hypoallergenics' Essence Skin-Saving antiperspirant and toothpaste – promoted as effective on areas of the body other than underarms and preventative of acne-like rashes around the mouth, respectively – makes them unapproved drugs, FDA says.

FDA Regulation
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Legislation

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Latest From Legislation

Rep. Pallone Seeks Answers In Tween Makeup Asbestos Controversy

The New Jersey congressman has taken a renewed interest in cosmetics safety issues of late, now requesting information from tween-focused retailer Justice about its ingredient sourcing and safety assurance practices, following a report linking one of its makeup products to asbestos contamination. The controversy could fuel the cosmetics reform conversation Pallone is working to kindle in Congress.

Cosmetic Ingredients Safety

Rep. Pallone Galvanized By FDA's 'Troubling Overview' Of Cosmetic Imports

FDA physically inspected less than 1% of the 2.9m cosmetic imports that reached the US in fiscal 2016, according to a letter from the agency released by Congressman Frank Pallone. The ranking member of the House Energy and Commerce Committee says he's aiming for a hearing in September on his bipartisan proposal to increase FDA's authority over the cosmetics sector.

Legislation FDA

Rose Report Podcast – July 2017

The Rose Sheet's editorial team counts off top news items in the cosmetics and dietary supplement sectors in July. In this installment we discuss developments under the EU’s cosmetics animal-testing ban, cosmetic preservatives positioned for elimination, and a bill advancing in California that would tighten requirements for continuity marketing; On the supplement side, warning letters are issuing regularly, but investments in the industry also are up, while innovative medical foods and probiotics are creating new growth opportunities.

Regulation Legislation
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Legal Issues

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Latest From Legal Issues

Waiting For FDA: Federal Courts Debate Stays Of 'Natural' Class Actions

Mayer Brown attorney Dale Giali discusses the "natural" litigation landscape, where litigants increasingly are sparring over the appropriateness of stays in light of FDA's comment-gathering initiative launched in 2015.

Legal Issues Advertising, Marketing & Sales

FTC Takes On 'Labyrinth' Behind Deceptive Tooth Whitener 'Trial' Offers

The Federal Trade Commission is making good on its promise to crack down on illegal negative option billing practices, targeting a scheme involving nearly 80 companies and 90 websites that lured unwitting consumers into paying up to $200 every month for what initially was presented as a low-cost trial "reward."

Advertising, Marketing & Sales Legal Issues

Rose Report Podcast – July 2017

The Rose Sheet's editorial team counts off top news items in the cosmetics and dietary supplement sectors in July. In this installment we discuss developments under the EU’s cosmetics animal-testing ban, cosmetic preservatives positioned for elimination, and a bill advancing in California that would tighten requirements for continuity marketing; On the supplement side, warning letters are issuing regularly, but investments in the industry also are up, while innovative medical foods and probiotics are creating new growth opportunities.

Regulation Legislation
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