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Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

United States Advertising, Marketing & Sales Drug Approval Standards

Plaintiff Digs Deep In Almay Archives For ‘Hypoallergic’ Fraud Evidence

In the absence of FDA regulations, federal courts generally are weighing hypoallergenic false-advertising arguments against the “reasonable consumer” standard, with varying results. However, Almay may have provided a more substantive basis for assessing the truthfulness of its hypoallergenic claims via a letter to FDA on the subject – albeit one from 1973.

Legal Issues Consumer United States

L’Oreal/Matrix Hair Care May Be Weighing Settlement In Case Of Missing Keratin

Plaintiffs scored class certification Aug. 15 in their false advertising suit against L’Oreal USA and its Matrix Essentials professional hair-care subsidiary, alleging that despite labeling and advertising cues, Biolage Keratindose hair products contain no keratin. Defendants’ motion to dismiss was largely denied in late 2017.

Legal Issues Consumer United States

Failed NDIs, FDA's Opioid Concerns Don't Stop Kratom Supplement Sales

Proponents say the herbal ingredient extracted from a plant in the coffee family and available in powders, capsules or pills and beverages has been used in the US since long before the October 1994 grandfather date for ingredients to be eligible for use in supplements without being notified to FDA as new. But FDA wants NDI notifications, and the four submitted so far have been incomplete or did not show safety for intended use in a supplement.

United States Dietary Supplements Consumer
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Regulation Explore this Topic

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Latest From Regulation

Kratom Group Sharpens Criticism Of 'Opiod' Finding In FDA's Report To DEA

American Kratom Association realizes FDA could have significant influence on DEA decision on whether to schedule kratom constituent ingredients as controlled substances. The association and experts on kratom say FDA's, which concluded that mitragynine and 7-hydroxymitragynine are opioids and use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.

United States Advertising, Marketing & Sales

UK Authority Launches Probe Into Social Influencer Disclosure Practices

The Competition and Markets Authority could pursue enforcement action based on findings from its investigation into leading social media influencers’ promotional activities, announced Aug. 16. The Federal Trade Commission has been focused increasingly on similar issues in the US.

Advertising, Marketing & Sales Regulation

Kratom Group Contests FDA's Opioid Finding, Requests Joint Meeting With NIDA

American Kratom Association accuses FDA of using “inaccurate, extrapolated and distorted” information on adverse events and deaths allegedly associated with the use of kratom to justify scheduling it as a controlled substance. After FDA Commissioner Gottlieb says the criticism is unfounded and kratom has no future as a dietary ingredient in the US, the group asks for joint meeting with NIDA to discuss "public health policy that allows for consumers to safely use natural kratom."

United States Consumer

Nutrition Labeling, Food-Borne Illness Shape FDA’s ‘Healthy People 2030’ Goals

FDA combines two surveys from the Healthy People initiative that tackles a range of consumer health topics every 10 years into a single survey, “FDA Food Safety, Health and Diet Survey.” The separate surveys have been deployed since 1990, “Food Safety Survey” and “Health and Diet Survey.” 

United States Consumer

Cyclamate Found In GU, Roctane Brand Energy Products On Recall

Recall of 35 products started July 18 by Advanced Food Concepts follows recalls started in June of four products by Prinova US and one by Sisel International also found to contain cyclamate.

International United States

Oral B Pro Most-Recommended Claim Backed By P&G's Global Dentist Surveys

UK Advertising Standards Authority says it rejected a complaint challenging whether the claim “number one dentist recommended brand worldwide” that P&G made in a TV ad was misleading and could be substantiated. P&G Health & Beauty Care Ltd. business in England responds with explanation of surveys with dentists it commissions to determine the professionals' regards for Oral B manual and power brushes.

United Kingdom United States

Legislation Explore this Topic

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Latest From Legislation

Appropriators Agree On Boosting FDA's Supplement Sector Work, Not On Funding

House and Senate appropriation bills state markedly different funding levels for FDA's spending on research into supplement and food products by its Center for Food Safety and Applied Nutrition and on enforcement work in the field by the Office of Regulatory Affairs. Appropriators are more aligned, though, in requests to FDA about its oversight of dietary supplement manufacturing and marketing.

United States Advertising, Marketing & Sales

Stakeholders Converge On California For Animal-Testing Bill Showdown

California lawmakers returning Aug. 6 from summer recess will have cosmetics industry reps and animal welfare groups vying for their ears, with the legislative clock ticking on a highly contentious proposal, SB 1249, to prohibit the sale of cosmetics containing ingredients tested “for any purpose” on animals.
Legislation State News

Exclusivity Period Allowed By OTC Monograph Reform Likely Up To Conference Committee

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

Legislation Consumer

Legal Explore this Topic

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Latest From Legal Issues

Adore Settles With Nationwide Class Over Apple Stem Cell Anti-Aging Claims

The estimated $700,000 settlement puts to rest allegations that the luxury skin-care firm deceived consumers with claims about its PhytoCellTec ingredient’s ability to slow the aging process. G.M. Collin, another PhytoCellTec Malus Domestica user, also appears to have reached a deal with plaintiffs in litigation challenging its anti-aging claims.

Legal Issues Cosmetic Ingredients

Target Cruises Past Hypoallergenic Cosmetic Suit, But Other Defendants On Rockier Road

The plaintiff in a proposed class action against Target Corporation for alleged “hypoallergenic” cosmetic fraud neglected to venture a definition for the term and focused to a distracting extent on claims ultimately found to be non-actionable puffery – e.g., “gentle.” Other hypoallergic suits pending around the US are built on sturdier ground and likely will be harder to dismiss.

Legal Issues Consumer

Chicago Supplement Firm Runs Out Of Chances To Correct GMP, Label Violations

"Despite repeated promises to fix the problems, Defendants have not done so. Accordingly, the United States now seeks a permanent injunction to bring Defendants’ operations into compliance with the law," US attorneys say in a complaint. Global Marketing Enterprises enters consent decree with FDA requiring that before resuming manufacturing and distributing supplements, it implement remedial measures to brings its operations into compliance.

United States Consumer

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Health, Beauty And Wellness News: GōL Bars, Soylent, IGC, Biotta, Neogen

Rosa Foods adds CFO and VP of brand marketing to guide strategy for Soylent meal replacement brand; Neogen Listeria Right Now detection system has AOAC accreditation; Garden of Life's new bar launches in Warrior Dash; IGC markets cannabis supplement in California for Alzheimer's; Biotta Juice new flavors.

United States Advertising, Marketing & Sales

Kratom Group Sharpens Criticism Of 'Opiod' Finding In FDA's Report To DEA

American Kratom Association realizes FDA could have significant influence on DEA decision on whether to schedule kratom constituent ingredients as controlled substances. The association and experts on kratom say FDA's, which concluded that mitragynine and 7-hydroxymitragynine are opioids and use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.

United States Advertising, Marketing & Sales

UK Authority Launches Probe Into Social Influencer Disclosure Practices

The Competition and Markets Authority could pursue enforcement action based on findings from its investigation into leading social media influencers’ promotional activities, announced Aug. 16. The Federal Trade Commission has been focused increasingly on similar issues in the US.

Advertising, Marketing & Sales Regulation

Ingredients Explore this Topic

Set Alert for Ingredients

Adore Settles With Nationwide Class Over Apple Stem Cell Anti-Aging Claims

The estimated $700,000 settlement puts to rest allegations that the luxury skin-care firm deceived consumers with claims about its PhytoCellTec ingredient’s ability to slow the aging process. G.M. Collin, another PhytoCellTec Malus Domestica user, also appears to have reached a deal with plaintiffs in litigation challenging its anti-aging claims.

Legal Issues Cosmetic Ingredients

NMI/J&J Study Probes Consumer Relationship With ‘Fragrance-Free’

Improved transparency is needed in fragrance labeling and ingredient disclosure, as well as greater “precision” in fragrance-free claims, but the demonization of all fragrance must stop, NMI researchers say, in partnership with J&J.

Cosmetic Ingredients Market Intelligence

GC3 Announces Preservative Challenge Winners; Sponsors Exploring Partnership Possibilities

Avisco, a biotech startup focused on the antimicrobial properties of the Inula viscosa plant, and IMD Natural Solutions, whose INS Glycolipid mushroom extract purportedly is “up to 80 times more effective than traditional preservatives,” are among winners named Aug. 6 by GC3.

Cosmetic Ingredients Innovation

Dietary Supplements Explore this Topic

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Latest From Dietary Supplements

Health, Beauty And Wellness News: GōL Bars, Soylent, IGC, Biotta, Neogen

Rosa Foods adds CFO and VP of brand marketing to guide strategy for Soylent meal replacement brand; Neogen Listeria Right Now detection system has AOAC accreditation; Garden of Life's new bar launches in Warrior Dash; IGC markets cannabis supplement in California for Alzheimer's; Biotta Juice new flavors.

United States Advertising, Marketing & Sales

Kratom Group Sharpens Criticism Of 'Opiod' Finding In FDA's Report To DEA

American Kratom Association realizes FDA could have significant influence on DEA decision on whether to schedule kratom constituent ingredients as controlled substances. The association and experts on kratom say FDA's, which concluded that mitragynine and 7-hydroxymitragynine are opioids and use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.

United States Advertising, Marketing & Sales

Kratom Group Contests FDA's Opioid Finding, Requests Joint Meeting With NIDA

American Kratom Association accuses FDA of using “inaccurate, extrapolated and distorted” information on adverse events and deaths allegedly associated with the use of kratom to justify scheduling it as a controlled substance. After FDA Commissioner Gottlieb says the criticism is unfounded and kratom has no future as a dietary ingredient in the US, the group asks for joint meeting with NIDA to discuss "public health policy that allows for consumers to safely use natural kratom."

United States Consumer
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