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Regulation and Law

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China Pilot Program May Let Cosmetic Importers Bypass Animal Testing

While nothing is certain and visibility is low as usual, China may be on the verge of allowing importers of ordinary (non-special use) cosmetics to forgo animal testing otherwise required by the China Food and Drug Administration when they go through the Shanghai Pudong New Area. Reportedly, a pilot program enabling a simplified filing process will kick off in March to test the system under consideration.

China Regulation Consumer

ICMAD Clutches To House Cosmetics Bill Before Specter Of ‘Activist FDA’

Locke Lord attorney Sharon Blinkoff, general counsel for the small-business trade group, says the newly introduced Safe Cosmetics Modernization Act is crafted to update cosmetics regulations without making room for oppressive oversight or a revival of the aggressively conservative FDA of decades past.

Legislation Regulation Consumer

Cancer Claim Warning: Health & Wellness Industry News Roundup

Northern Health Products trips on drug claims; metabolic syndrome patients' bodies hide vitamin E; and multi-micronutrients during pregnancy benefits children's cognitive abilities.

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Regulation

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Latest From Regulation

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

Canada Tilts At Unneeded Fixes In Self-Care Product Regulation Overhaul – Industry

Health Canada says its planned overhaul will not scrap the current natural health product framework, but industry is skeptical. In a Council for Responsible Nutrition webinar, an industry consultant says marketers of OTC drugs, supplements and cosmetics are discussing the proposal's negative implications with the agency.

Consumer Regulation

Former FDA Commish Califf Advocates Cosmetics Registration, AE Reporting

FDA is hampered in its public safety mission under current law, which does not require cosmetics firms to register marketed products or report adverse events, former agency head Robert Califf says. His June 26 editorial in Jama Internal Medicine accompanies an analysis of FDA's cosmetics adverse-event data.

Regulation FDA

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

S.K. Labs VP Imprisoned Before Trial On Charges Linked To USPlabs

S.K. Labs VP Sitesh Patel was sentenced for his conviction in an April trial of single counts of conspiracy to defraud FDA and conspiracy to commit mail fraud and three counts of mail fraud. He faced up to 85 years in prison and up to $1.25m in fines.

Dietary Supplements Regulation

FDA Flexes Warnings For Steroid Ingredients On Supplement Labels

Warning letters state that ingredients listed on labels for AndroPharm and Hardcore Formulations brand products "are synthetic steroids and do not constitute dietary ingredients" under FDA regulations.

Dietary Supplements Legal Issues
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Legislation

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Latest From Legislation

Cleaning Product Bills' Fate Could Bear On Cosmetic Disclosure Efforts

If proposed cleaning product "right to know" legislation were to pass in California or US Congress, it could put new wind in NGOs' sails, powering efforts to unmask fragrance ingredients and contaminants lurking in cosmetics.

Legislation Consumer

Fragrance Industry Wafts Policy Concerns To Key Congress Members

International Fragrance Association North America reps and members met in late May with sponsors of the Personal Care Products Safety Act, among other US Congress members, to discuss disclosure concerns, tax reform and other top-of-mind issues for the fragrance industry in the new political environment.

Legislation Consumer

Industry Eyes NDI Notification Common Ground With Gottlieb-Led FDA

CHPA and CRN look forward to working with FDA to develop a path for the identification of pre-DSHEA ingredients, but say the FDA’s revised draft guidance for new dietary ingredient notifications still hampers innovation.

Dietary Supplements Consumer
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Legal Issues

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Latest From Legal Issues

Honest Company Heads For $1.55M Settlement In 'SLS-Free' Dispute

Honest may be close to putting its legal woes behind it and chalking them up to growing pains, with proposed settlements notified in California and New York district courts. Plaintiffs have accused the firm of misleading consumers with deceptive "SLS-free," "natural" and other claims.

Legal Issues Advertising, Marketing & Sales

J&J May Have Just Received Lifeline Out Of St. Louis Talc Tort Morass

A judge in the Missouri state court where J&J has suffered a series of hefty losses declared a mistrial June 19 in the latest talc-cancer case to be heard by jurors. The decision came two days after a US Supreme Court decision that also could trigger reversals of costly J&J verdicts currently under appeal.

Legal Issues Consumer

S.K. Labs VP Imprisoned Before Trial On Charges Linked To USPlabs

S.K. Labs VP Sitesh Patel was sentenced for his conviction in an April trial of single counts of conspiracy to defraud FDA and conspiracy to commit mail fraud and three counts of mail fraud. He faced up to 85 years in prison and up to $1.25m in fines.

Dietary Supplements Regulation
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