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CIR Panel Needs Outside Expertise To Continue Parabens Re-Review

CIR's experts tabled their re-review of parabens safety earlier this month in light of new animal research indicating developmental/reproductive effects in the offspring of rats that were orally administered relatively low butylparaben doses. The panel also issued an insufficient data announcement for preservative polyaminopropyl biguanide.

Cosmetic Ingredients Consumer United States

FDA Puts Kibosh On Perfectly Posh For Unapproved Drug Claims

Perfectly Posh, which sells a colorful range of skin, hair and bath products online and through independent social sellers, draws an FDA warning letter for claims about acne, eczema and dandruff treatment, among others.

FDA Regulation Consumer

Rose Report Podcast – May 2017

The Rose Sheet's editorial team counts down the top five news items or issues in both the cosmetics and dietary supplement sectors over the past month, including cosmetics reform legislation and its potential bearing on FDA inspections, NGO attacks on sunscreens and developments that could be welcome to companies in terms of how class actions and other litigation are treated by federal courts.

Regulation Legal Issues Legislation
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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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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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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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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

Carlyle Trims Nature's Bounty Assets: Private Equity Rolls In Supplement Space

Carlyle's $2.2bn sale of Nature's Bounty's Holland & Barrett business to a Russian investment fund is the latest sign of the private equity sector's continuing interest in the health and wellness space.

Dietary Supplements M & A

Hi-Tech's DMAA Argument Dismissed: Health And Wellness Industry News

Hi-Tech gets no reconsideration; CPSC considers regulatory costs; That's It Nutrition gets cash; recalls; and more news in brief.

Dietary Supplements Recalls

Ingredients Explore this Topic

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CIR Expert Panel Finalizes 2018 Review Priorities At June Meeting

Fourteen cosmetic ingredients are up for first looks by the CIR panel in 2018. Also at its June meeting, the group issued two final ingredient reports and five tentative reports, as well as two insufficient data announcements, and tabled its parabens re-review in order to solicit outside expertise on new DART data.

Cosmetic Ingredients United States

Cosmetic Ingredient Review Report Status

Chart: Data compiled by "Rose Sheet" from information in CIR reports following the Expert Panel's June 12-13 meeting.

Cosmetic Ingredients Consumer

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

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Carlyle Trims Nature's Bounty Assets: Private Equity Rolls In Supplement Space

Carlyle's $2.2bn sale of Nature's Bounty's Holland & Barrett business to a Russian investment fund is the latest sign of the private equity sector's continuing interest in the health and wellness space.

Dietary Supplements M & A

Hi-Tech's DMAA Argument Dismissed: Health And Wellness Industry News

Hi-Tech gets no reconsideration; CPSC considers regulatory costs; That's It Nutrition gets cash; recalls; and more news in brief.

Dietary Supplements Recalls

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
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