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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.

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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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SARMs Subject To Steroids Scheduling By DEA Under Hatch, Whitehouse Bill

The Utah Republican and Rhode Island Democrat sponsor legislation to make selective androgen receptor modulators subject to the same authority the Drug Enforcement Administration has to regulate anabolic steroids. Hatch said the SARMs Control Act of 2018 would "ensure that the DEA has the authority it needs to prevent abuse and diversion of these dangerous substances.”

International United States

CIR Objectivity In Safety Substantiation Questioned By Women's Voices for Earth

In a report released April 24, WVE highlights what it says are CIR’s shortcomings, pointing out a conflict of interest due to the group’s industry funding and governance, as well as its narrow scope solely focused on consumer safety – not the safety of workers or environmental impact – and the expert panel’s approach to inhalation hazards and data gaps.
International United States

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

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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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CIR Defends Independence, Suggests Confusion Prompted WVE Criticism

Cosmetic Ingredient Review head Bart Heldreth suggests that not only are Women's Voices for the Earth's concerns misguided, but the group may hold a grudge from past instances when the CIR Expert Panel was in disagreement with the group. Heldreth maintains the expert panel “has established a strong record of protecting public health through its reviews and safety assessments of ingredients used in cosmetics.

International United States

CBD Cancer Claim Gets NAD Attention: Health And Wellness News

NAD sends CBD oil cancer claim to FTC; Supplement OWL passes 10,000 at first anniversary; Herbalife Nutrition two-for-one stock split; and Après resumes shipping with funding.
Advertising, Marketing & Sales Dietary Supplements

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.

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CIR Defends Independence, Suggests Confusion Prompted WVE Criticism

Cosmetic Ingredient Review head Bart Heldreth suggests that not only are Women's Voices for the Earth's concerns misguided, but the group may hold a grudge from past instances when the CIR Expert Panel was in disagreement with the group. Heldreth maintains the expert panel “has established a strong record of protecting public health through its reviews and safety assessments of ingredients used in cosmetics.

International United States

CIR Objectivity In Safety Substantiation Questioned By Women's Voices for Earth

In a report released April 24, WVE highlights what it says are CIR’s shortcomings, pointing out a conflict of interest due to the group’s industry funding and governance, as well as its narrow scope solely focused on consumer safety – not the safety of workers or environmental impact – and the expert panel’s approach to inhalation hazards and data gaps.
International United States

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

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SARMs Subject To Steroids Scheduling By DEA Under Hatch, Whitehouse Bill

The Utah Republican and Rhode Island Democrat sponsor legislation to make selective androgen receptor modulators subject to the same authority the Drug Enforcement Administration has to regulate anabolic steroids. Hatch said the SARMs Control Act of 2018 would "ensure that the DEA has the authority it needs to prevent abuse and diversion of these dangerous substances.”

International United States

CBD Cancer Claim Gets NAD Attention: Health And Wellness News

NAD sends CBD oil cancer claim to FTC; Supplement OWL passes 10,000 at first anniversary; Herbalife Nutrition two-for-one stock split; and Après resumes shipping with funding.
Advertising, Marketing & Sales Dietary Supplements

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.

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