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In Time For Halloween, FDA Rule Conjures Up Specter Of Renewed Cosmetic Lead Debate

FDA’s final rule is specific to lead acetate’s use in hair-coloring products, but the agency’s recognition of current consensus – “that there is no safe exposure level for lead” – could spook the wider cosmetics industry, particularly given that some of the same NGO petitioners that drove the rulemaking are clamoring for an all-out ban on trace lead in lipsticks and externally applied cosmetics.

Regulation FDA Consumer

Cosmetic Ingredient Innovation In An Increasingly Cruelty-Free World; Is It Possible?

Visibility is low into the availability of new cosmetic ingredients since 2013, but there does appear to be a viable pathway for innovations to reach the EU market, despite the animal testing ban, as well as California, where similar prohibitions will go into effect in 2020. Still, industry’s best bet is to continue investing in alternative methods development and promoting their acceptance with regulators.

Legislation Cosmetic Ingredients Consumer

Unilever Seeks End To Litigation Over St. Ives Scrub, Plaintiffs’ ‘Fake Medical Condition’

In April 2017, Unilever failed to dismiss a putative class action in California’s Central District alleging that its St. Ives Apricot Scrub is unfit for sale due to the potential of its crushed walnut shells to cause “microtears” in skin. Now the firm seeks summary judgment in the matter, maintaining that plaintiffs are relying on “junk science” to assert the possibility of a made-up medical condition.

Legal Issues Consumer United States

Amarin Asks To Stifle Supplement Firms About Its Omega-3 Trial Results

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.

Dietary Supplements Commercial United States
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Regulation Explore this Topic

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Economic Adulteration Underscored In GAO Memory Supplements Study

Audit finds two of three memory supplements tested contain none or lower levels of active supplement than stated on labeling. In a report for current and previous  ranking minority members of Senate Special Committee on Aging, GAO points to continuing issues with economic adulteration for gingko biloba.

Dietary Supplements Regulation

Mosquito Repellent Promotion Tumbles On Undisclosed Paid Social Media Plugs By US Olympic Gymnasts

FTC proposes settlements with marketing and public relations firm Creaxion and Inside Publications over regulatory violations in advertising for Fit Organic Mosquito Repellent including failing to disclose US Olympic gymnasts as paid social medial endorsers and misrepresenting that paid commercial ads are opinions from an independent or objective publishers or sources.

Commercial Regulation

Cosmetics Recalls For August-October Period Have One Familiar Thing In Common: All Were Voluntary

Under current cosmetics regulations FDA does not have the authority to order product recalls, as it does in the dietary supplement space, for example. Voluntary cosmetic recalls have been typically light in recent months, most often citing microbiological issues.

Regulation FDA

Metric Weights For Probiotics Mislead But CFUs Inform, Say Industry Groups

Council for Responsible Nutrition, Consumer Healthcare Products Association and Natural Products Association urge FDA to allow colony forming units on probiotic product labels while nixing current labeling regulation’s allowance of metric weight, as the measurement does not reflect live microbials.

Dietary Supplements Regulation

FDA Plans Consumer Survey To Better Understand Cosmetics Allergy Prevalence

The agency will accept public comment for 60 days on its proposed survey to gain insight into “consumer use of cosmetic products, the frequency of adverse events believed to be caused by allergens in cosmetics, consumer awareness of the problem, and actions (if any) taken to avoid the allergens.”

FDA Regulation

Mandatory Recall Guidance Positions FDA For ‘Robust’ Use Of Authority

Final guidance on mandatory recall authority under FSMA specifies how FDA allows firms opportunities for voluntary recalls and evidence it may consider when deciding whether to mandate a recall. But a consumer advocacy group critical of FDA says the guidance adds nothing for protecting public health.

Dietary Supplements Regulation

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European Trade Groups To Cosmetics Firms: Be Prepared For ‘No Deal’ Brexit

The UK is converting the EU’s Cosmetics Regulation and REACH into UK law, holding out hope that mutual interests will yield an arrangement for “frictionless trade.” However, the Cosmetic, Toiletry and Perfumery Association notes “the political landscape is very uncertain.”

Legislation Policy & Regulation

EU’s Microplastic Clampdown Has Echoes Of US MFWA; Will Bioplastics Be Left Out In The Cold Again?

The future of microplastics use in the European cosmetics sector hangs in the balance as legislative efforts move forward in line with the Commission’s Plastics Strategy released in January. A key question is whether next-generation, biodegradable plastics will get caught up in any bans that transpire, limiting manufacturers’ options and dashing the hopes of emerging producers with cosmetic interests.

Legislation Cosmetic Ingredients

FDA Guarded On California Animal-Testing Ban’s Implications For Federal Cosmetics Compliance

The agency isn’t saying much about California’s new law, but it has indicated previously that alternative methods may not hold up under federal regulatory scrutiny should safety issues arise. FDA and other regulators also have noted that manufacturers’ liability when relying on experimental safety assessment techniques has yet to be tested in the courts.

Legislation State News

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Mosquito Repellent Promotion Tumbles On Undisclosed Paid Social Media Plugs By US Olympic Gymnasts

FTC proposes settlements with marketing and public relations firm Creaxion and Inside Publications over regulatory violations in advertising for Fit Organic Mosquito Repellent including failing to disclose US Olympic gymnasts as paid social medial endorsers and misrepresenting that paid commercial ads are opinions from an independent or objective publishers or sources.

Commercial Regulation

ThermoLife Tries To Flex Litigation Muscle Against Nitrate Marketers In False Advertising Complaints

ThermoLife International files two false advertising complaints alleging competitors also marketing nitrate-based workout products deceive consumers and disparage its business. The company is seeking damages after setbacks in patent infringement complaints.

Dietary Supplements Commercial

Keystone Labs Court-Ordered To Halt OTC Drug Manufacturing; Cosmetics Not Affected, It Says

Keystone Labs agrees to cease manufacturing OTC drugs following a 2013 FDA warning letter and repeated GMP violations noted during inspections, including failure to investigate sources of contamination. Firm suggests it will continue making cosmetic hair- and skin-care formulas while outsourcing OTC product manufacturing.

Legal Issues Manufacturing

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Economic Adulteration Underscored In GAO Memory Supplements Study

Audit finds two of three memory supplements tested contain none or lower levels of active supplement than stated on labeling. In a report for current and previous  ranking minority members of Senate Special Committee on Aging, GAO points to continuing issues with economic adulteration for gingko biloba.

Dietary Supplements Regulation

Publisher’s Spotlight: The 2019 OTC Marketing Awards Is Open For Entries

Recognizing the best of the British OTC industry, the OTC Marketing Awards include honors for best product innovations, packaging and marketing campaigns, to name a few. Entries are being accepted through Dec. 7.

Innovation Advertising, Marketing & Sales

P&G Grooming Quits Counting Blades, Innovates In New Directions While Battling DTC Disruptors

In the six years since Dollar Shave Club’s viral video and pioneering business model upended the men’s razor market, P&G’s grooming business has been scrambling to reestablish itself and win back market share. The division’s first-quarter results suggest that its fresh innovation approach, updated messaging and direct-to-consumer investments are paying off, though significant competitive challenges remain.

Business Strategies Innovation

Ingredients Explore this Topic

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NGOs Demand Action From Amazon, eBay On Mercury-Containing Skin-Lightening Creams

The e-commerce giants should keep pace with regulatory notifications regarding mercury-containing cosmetics, implementing their restricted products policies accordingly, and require approval of skin-lightening products prior to sale, according to a coalition of 51 NGOs. They point to recent testing that found skin creams on Amazon.com and eBay.com to contain mercury at levels up to 30,000 ppm.

Cosmetic Ingredients NGO Action

EU’s SCCS Reissues Guidance On Cosmetic Ingredient Testing With Updated Non-Animal Method Perspectives

The Scientific Committee on Consumer Safety’s guidance offers perspective on new approach methodologies that can be used to substantiate cosmetic ingredient safety, as well as areas where alternative strategies continue to be insufficient. The document also includes updated criteria for multi-constituent natural ingredients at a time of increasing industry use.

Cosmetic Ingredients Safety

FDA Plans Consumer Survey To Better Understand Cosmetics Allergy Prevalence

The agency will accept public comment for 60 days on its proposed survey to gain insight into “consumer use of cosmetic products, the frequency of adverse events believed to be caused by allergens in cosmetics, consumer awareness of the problem, and actions (if any) taken to avoid the allergens.”

FDA Regulation

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Economic Adulteration Underscored In GAO Memory Supplements Study

Audit finds two of three memory supplements tested contain none or lower levels of active supplement than stated on labeling. In a report for current and previous  ranking minority members of Senate Special Committee on Aging, GAO points to continuing issues with economic adulteration for gingko biloba.

Dietary Supplements Regulation

ThermoLife Tries To Flex Litigation Muscle Against Nitrate Marketers In False Advertising Complaints

ThermoLife International files two false advertising complaints alleging competitors also marketing nitrate-based workout products deceive consumers and disparage its business. The company is seeking damages after setbacks in patent infringement complaints.

Dietary Supplements Commercial

Perrigo Pivots To 'Self Care' For 'Massive Opportunity' Beyond OTC Drugs

Providing self-care products "opens this organization up to massive opportunity" which Perrigo will identify in early 2019, says new CEO Murray Kessler. It remains committed to selling or spinning off its Rx unit, though it's "just a few FDA approvals away from significantly" growing, he says as firm reports $68m net loss in its latest quarter.

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