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CIR Recalculates Parabens Safety Margins; Will Expert Panel’s Confidence Be Shaken?

The Cosmetic Ingredient Review’s newly figured margins of safety for single- and multi-paraben use in cosmetic products are dramatically lower than previous MOSs that informed the Expert Panel’s 2008 “safe as used” conclusions. Whether the panel still deems the MOSs sufficiently protective is the question going into the group’s Sept. 24-25 meeting.

Cosmetic Ingredients Safety Consumer

What’s In A Name? Babyganics Settles False Advertising Allegations To Tune Of $2.2M

The SC Johnson brand can continue to use the name Babyganics as long as it specifies on product labeling which ingredients are organic, and which aren’t, per a pending class action settlement in New York’s Southern District. The company also has agreed to sunscreen batch testing for a three-year period to verify the authenticity of SPF claims.

Legal Issues Consumer United States

Warnings On Kratom Opioid Withdrawal Claims Mark Tip Of FDA Concerns

Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.

United States Advertising, Marketing & Sales Consumer

Hemp Product Market Future Backed By McConnell, Fate Depends On Farm Bill

The surprising support of Senate majority leader Mitch McConnell is integral to the success of a provision in legislation to reauthorize USDA programs that would clarify hemp's removal from the federal list of controlled substances and ease limits on its production in the US. Meanwhile, Charlotte's Web Holdings' recent $100m IPO is a strong sign of investors' confidence in the future market for hemp products.

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Regulation Explore this Topic

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Latest From Regulation

Sea & Ski, Back On Sunscreen Scene, Slapped By Rival Who Never Left

Sea & Ski’s infrared protection claims read as a bold grab for competitive leverage after its disappearance from the market for more than a decade. But old rival Coppertone isn’t sitting idly by.

Advertising, Marketing & Sales Regulation

NAD: Sea & Ski Sunscreens May Go ‘Beyond UV,’ But Not To Infrared Zone

Cross Brands Manufacturing’s stingily hand-picked in vitro test results for Sea & Ski sunscreens do not demonstrate a clear, consumer-relevant infrared protection capability, let alone show that IR defense translates to meaningful skin-health benefits, according to the National Advertising Division’s Sept. 7 decision.

Advertising, Marketing & Sales Regulation

Health, Beauty And Wellness Regulatory News: Warnings, Alerts, Recalls

Fourth recall of homeopathics linked to contaminated water; FDA posts alerts about Texas coop's products; and warnings note drug claims, GMP problems, same-site drug production.

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FDA Scientists Give Leadership High Marks; Some Worry About Industry Influence

Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.

FDA BioPharmaceutical

FDA OK With Probiotic Weight CFUs In Supplement Facts Labels, For Now

Until CFSAN decides whether to engage in a rulemaking to amend FDA's supplement labeling regulation, it intends "to exercise enforcement discretion for those firms that choose to declare the quantitative amount of live microbial ingredients in the Supplement Facts label by CFUs in addition to weight," according to draft guidance.

United States Advertising, Marketing & Sales

Injunction Ends Spiked Supplement Marketers' Attempt To Deceive FDA

Other than making apparently false statements to FDA about no longer selling spiked supplements, operators of R Thomas Marketing, identified online as a social media consultancy, and S Hackett Marketing, which d/b/a "Just Enhance" and apparently sells a variety of consumer goods, made no contact with FDA or with DoJ, according to court order entered as a permanent injunction.

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Legislation Explore this Topic

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Latest From Legislation

Farm Bill Would Boost USDA Organic Program Funding, Supply Chain Safety

Five-year reauthorization of USDA programs is controversial on numerous fronts because of its breadth. It includes programs from federal crop insurance to the Supplemental Nutrition Assistance Program, which accounts for 80% of the total spending. "As an industry, we need to be out there demonstrating support for the farm bill and why it’s so important for farmers to have that stability and consumers as well,” says Organic Trade Association executive Megan DeBates.

United States US States

CFI Sets Sights On US, Global Bans To ‘Close The Door’ On Cosmetic Animal Testing

California’s passage of the Cruelty-Free Cosmetics Act could trigger a state-level domino effect leading to a federal ban, according to Cruelty Free International’s North America Campaign Manager Monica Engebretson. Meanwhile, the NGO will continue to push for a global ban through the United Nations.

Animal Testing Legislation

California’s Professional Cosmetic Labeling Bill Passes Unopposed

While overshadowed by contentious cosmetic animal-testing legislation, AB 2775 also passed in the closing days of California’s 2017-2018 legislative session, another example of the state’s eagerness to take on cosmetics issues it views as inadequately addressed at the federal level.

State News Legislation

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California’s SB 1249 Could Plant Seeds For New Plaintiff Cottage Industry

The Cruelty-Free Cosmetics Act, passed Aug. 31, conceivably could give rise to consumer suits alleging violation of California’s Unfair Competition Law due to companies’ alleged use of prohibited animal testing to develop cosmetic products or substantiate their safety. Regardless, claiming exemptions under SB 1249 promises to be risky business with limited rewards.

Legal Issues US States

Beauty Device Brands Take Heed: Ulthera Fraud Suit Rooted In ‘FDA-Approved’ Versus ‘FDA-Cleared’

The terms “FDA-approved” and “FDA-cleared” are not interchangeable; rather they denote distinct premarket regulatory pathways for medical devices with differing levels of FDA endorsement. Merz’s Ulthera unit recently failed to dismiss a false-advertising class action challenging its “FDA-approved” claims on an ultrasound system used in clinical settings for line and wrinkle treatment.

Legal Issues Consumer

California’s Cruelty-Free Cosmetics Act Makes New Ingredients Officially Endangered

It’s debatable the extent to which SB 1249, now headed to the governor’s desk, will improve animals’ lot, but cosmetic ingredient innovation is almost certain to suffer. Industry could escalate efforts behind alternative methods development, or there’s another possible solution: federal preemption.

Legislation Legal Issues

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Sea & Ski, Back On Sunscreen Scene, Slapped By Rival Who Never Left

Sea & Ski’s infrared protection claims read as a bold grab for competitive leverage after its disappearance from the market for more than a decade. But old rival Coppertone isn’t sitting idly by.

Advertising, Marketing & Sales Regulation

NAD: Sea & Ski Sunscreens May Go ‘Beyond UV,’ But Not To Infrared Zone

Cross Brands Manufacturing’s stingily hand-picked in vitro test results for Sea & Ski sunscreens do not demonstrate a clear, consumer-relevant infrared protection capability, let alone show that IR defense translates to meaningful skin-health benefits, according to the National Advertising Division’s Sept. 7 decision.

Advertising, Marketing & Sales Regulation

Kratom Industry GMPs Target Swaying FDA By Exceeding Agency Standards

“We want to show that the kratom industry is maturing, that people want to do the right thing,” says AKA Chairman Dave Herman. The standards go “well beyond” FDA's minimum GMP requirements for dietary supplements, AKA says.

United States Advertising, Marketing & Sales

Ingredients Explore this Topic

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CIR Experts To Take First Look At Brown Algae Ingredients, Strategize For MI/MCI Re-Review

The Cosmetic Ingredient Review’s draft report on brown algae-derived ingredients is up for Expert Panel consideration Sept. 24-25, and five Ginkgo biloba ingredients could receive final safe-as-used sign-off. CIR also seeks the panel’s help in preparing a re-review document for the MI/MCI preservative combination, which is overdue for an updated assessment with usage up significantly since 1992.

Cosmetic Ingredients Safety

Johnson’s Leads J&J On Road To Fragrance Transparency

Beginning with its newly relaunched washes, lotions and hair products, Johnson’s is providing product-specific detail on fragrance components in a transparency move that other J&J skin-care brands will be following, according to a company rep.

Cosmetic Ingredients Business Strategies

FDA Contracts For QRA Model To Determine Safe Use Levels For 26 Fragrance Allergens

The ingredients at issue already must be labeled on cosmetic products in the EU due to their recognized sensitization and allergy potential. FDA expects to award the contract by the end of September, and finished work will be due to the agency within 18 months thereafter.

Cosmetic Ingredients FDA

Dietary Supplements Explore this Topic

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Kratom Industry GMPs Target Swaying FDA By Exceeding Agency Standards

“We want to show that the kratom industry is maturing, that people want to do the right thing,” says AKA Chairman Dave Herman. The standards go “well beyond” FDA's minimum GMP requirements for dietary supplements, AKA says.

United States Advertising, Marketing & Sales

Farm Bill Would Boost USDA Organic Program Funding, Supply Chain Safety

Five-year reauthorization of USDA programs is controversial on numerous fronts because of its breadth. It includes programs from federal crop insurance to the Supplemental Nutrition Assistance Program, which accounts for 80% of the total spending. "As an industry, we need to be out there demonstrating support for the farm bill and why it’s so important for farmers to have that stability and consumers as well,” says Organic Trade Association executive Megan DeBates.

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Health, Beauty And Wellness News: SIDI Protocol, Synthetic Labeling Survey, Recalls, Product Launches

Prebiotic aloe in a Veralixir shot; Carpe targets excessive sweating; Young Living offers subscriptions; Berry Sleepy puts $2.8m behind marketing; Jigsaw supports children's Mineral Power program; Trust Transparency survey on synthetic ingredient labeling; and Beaumont Bio homeopathics recalled.

United States Advertising, Marketing & Sales
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