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FDA’s ‘Exploratory’ MUsT Won't Affect OTC Sunscreen Rulemaking Schedule

FDA’s plans for a maximal usage study to better understand sunscreen ingredient absorption should not hold up delivery of a final OTC sunscreen monograph by the end of 2019, the agency says. There are questions among industry stakeholders as to how FDA’s research relates to MUsTs currently requested from TEA sponsors seeking GRASE approvals.

Regulation FDA Consumer

NGOs’ Suit Against FDA Dismissed; No Standing In Formaldehyde Matter, Court Rules

“Injuries to an organization’s government lobbying and issue advocacy programs cannot be used to manufacture standing,” a D.C. district court judge asserts in his ruling against the Environmental Working Group and Women’s Voices for the Earth.

Legal Issues NGO Action Consumer

Beauty Leaders Tune Into Digital Startup Space: ‘The Disruptors Are Out There’

J&J and Coty are among firms getting inside looks at digital beauty startups via accelerator programs that award funding and expertise to promising concepts. Emerging platforms for virtual sampling and personalized skin-care are proving big draws.

Commercial Research & Development Business Strategies

Injunction Closes Another Supplement Firm: Health And Wellness Industry News

Mannatech slumps on Americas downturn; MusclePharm navigates bumps in turnaround; kratom recalls updated; and FDA, DoJ shutter another supplement firm

International United States Dietary Supplements
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Jason Mouth Rinse Among Recent Health And Wellness Product Recalls

Recent FDA recall announcements also include Medline Remedy Essentials No Rinse Foaming Cleanser, another firm recalling kratom-containing dietary supplements potentially contaminated with salmonella and a separate marketer expanding its recall of kratom products.
International United States

Abbott Follows Strong Q1 With Ensure Max: Health And Wellness Industry News

Abbott follows strong quarter with Ensure Max launch; FDA warns Amerigo on ADHD, schizophrenia claims; Harlem Globetrotters score 'Official Juice Drink'; and Texas considers CBD-product ban.
International United States

FDA To Hanbul Cosmetics: You’re Marketing Noncompliant Drugs

The agency’s warning letter cites the Korean firm, whose offering includes sunscreen and skin-whitening products, for violations of drug CGMP regulations. Problems identified during a recent inspection include microbiological testing failures and questions about equipment quality.

Regulation FDA

FDA Guidance Stirs In Caffeine Restrictions For Supplements

"An inherent feature of the conditions of use for such products is that the consumer must separate out a very small, precise serving from a potentially lethal amount of product – a task that poses a significant or unreasonable risk of illness or injury," says FDA's Office of Dietary Supplement Programs. Only products containing pure caffeine that packaged in the ingredient in premeasured doses and bulk caffeine that is sufficiently diluted will be considered compliant.

International United States

FDA Supplement GMP Crosshairs More Frequently On Smaller Firms

GMP violation warnings to three small dietary supplement firms in late March reflect a “thoughtful shift” by FDA toward inspections of smaller firms, says UNPA President Loren Israelsen. With the supplement GMP final rule past its 10-year anniversary, firms should be meeting their requirements.

International United States

UFC Fighter Hits Genkor Tribulus Supplement With SARMs Complaint

Former UFC heavyweight champ Joshua Barnett's lawsuit filed in California state court two weeks after his suspension from UFC bouts was lifted alleges that BioKor’s Genkor Tributestin 750 supplement he used contained an undeclared ingredient, ostarine, a selective androgen receptor modulator that is a "dangerous chemical that is not approved for human consumption under any circumstances."

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Hawaiian Sunscreen Ban On Brink Of Passage; Lawmakers Hashing Out Final Details

Conferees from the state’s House and Senate will meet in an effort to resolve differences in legislation to ban the sale of oxybenzone- and octinoxate-containing sunscreens due to environmental concerns. A consensus version of the bill must be available for final reads by April 26.

Cosmetic Ingredients Legislation

Congressional Appropriators Press FDA For Feminine Cleanser Guidance

Colorants approved exclusively for external use are central to concerns raised about feminine wash products by NGO Women’s Voices for the Earth and its ears in Congress. However, FDA’s ongoing review could explore the broader question of whether such items are properly classified and controlled.

Legislation FDA

ICMAD Responds To Senate Proposal: Cosmetics Should Not Be Regulated Like Foods

Small business advocate says the Senate Health Committee’s discussion draft – the Modernization of Cosmetics Regulation Act – would impose burdens on industry on par with requirements for foods. But while food products continue to pose significant risks, “no such record exists for the cosmetics industry,” the trade group asserts.

Legislation Consumer

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‘Hypoallergenic’ Class Actions Bubbling Up: The New ‘Natural’ Scourge?

There are similarities between trending “hypoallergenic” class actions and “natural” litigation that for years has been the bane of many leading brands and a cash cow for plaintiffs.

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Target, Whole Foods Have Irritated Reactions To ‘Hypoallergenic’ Product Suits

The outcomes of proposed class actions against Target Corporation and Whole Foods Market will provide bright signals as to whether plaintiffs have traction in the courts to bring false-advertising suits against “hypoallergenic” cosmetic marketers. The retailers’ motions to dismiss are pending currently.

Legal Issues Advertising, Marketing & Sales

UFC Fighter Hits Genkor Tribulus Supplement With SARMs Complaint

Former UFC heavyweight champ Joshua Barnett's lawsuit filed in California state court two weeks after his suspension from UFC bouts was lifted alleges that BioKor’s Genkor Tributestin 750 supplement he used contained an undeclared ingredient, ostarine, a selective androgen receptor modulator that is a "dangerous chemical that is not approved for human consumption under any circumstances."

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Turnaround Lagging, Vitamin Shoppe Heeds Hedge Fund Direction

Shah Capital Management, with 17.7% of Vitamin Shopper shares, and Vintage Capital Management , which owns 14.8%, will appoint three of five replacements to Vitamin Shoppe's board and will have a say in the other two. Vitamin Shoppe also will sell its under-performing contract manufacturing unit and tender, subject to ratification by Shah and Vintage, up to $25m of its common stock at a per-share price not to exceed $5.

International United States

P&G’s Q3: Negative Pricing, ‘Change In Tone’ Have Analysts Spooked

Firm’s slowing organic growth and negative pricing impacts in the third quarter reflect much-talked-about pressures in health and beauty care. However, the scope of the challenges is becoming clearer, and analysts are questioning whether P&G’s “not business as usual” response will be enough.

Sales & Earnings Business Strategies

P&G Adds Merck's Brands, Expands Consumer Health Categories, Footprint

P&G’s planned purchase of Merck KGaA’s consumer health care business will grow its personal health portfolio 50%, expand its OTC drug and supplement business abroad and open up new categories. CEO David Taylor framed the acquisition as another step in the firm's ongoing portfolio shakeup.
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Hawaiian Sunscreen Ban On Brink Of Passage; Lawmakers Hashing Out Final Details

Conferees from the state’s House and Senate will meet in an effort to resolve differences in legislation to ban the sale of oxybenzone- and octinoxate-containing sunscreens due to environmental concerns. A consensus version of the bill must be available for final reads by April 26.

Cosmetic Ingredients Legislation

IFRA Hosts Capitol Hill Scent Experience In Timeout From Policy Concerns

The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.

Cosmetic Ingredients United States

J&J To Appeal $37M Mesothelioma Verdict, A First In Talc Trials

The mesothelioma liability case marks the first in New Jersey, the first involving a male plaintiff and the first to result in a plaintiff verdict. Punitive damages, potentially on top of the $37m in compensatory damages, have yet to be decided in the matter linking J&J’s talc to asbestos dangers.

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Turnaround Lagging, Vitamin Shoppe Heeds Hedge Fund Direction

Shah Capital Management, with 17.7% of Vitamin Shopper shares, and Vintage Capital Management , which owns 14.8%, will appoint three of five replacements to Vitamin Shoppe's board and will have a say in the other two. Vitamin Shoppe also will sell its under-performing contract manufacturing unit and tender, subject to ratification by Shah and Vintage, up to $25m of its common stock at a per-share price not to exceed $5.

International United States

P&G Adds Merck's Brands, Expands Consumer Health Categories, Footprint

P&G’s planned purchase of Merck KGaA’s consumer health care business will grow its personal health portfolio 50%, expand its OTC drug and supplement business abroad and open up new categories. CEO David Taylor framed the acquisition as another step in the firm's ongoing portfolio shakeup.
International Germany

Abbott Follows Strong Q1 With Ensure Max: Health And Wellness Industry News

Abbott follows strong quarter with Ensure Max launch; FDA warns Amerigo on ADHD, schizophrenia claims; Harlem Globetrotters score 'Official Juice Drink'; and Texas considers CBD-product ban.
International United States
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