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Monograph Reform Legislation In Play As FDA, OTC Industry Get Real On Changes

FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.

FDA Regulation Drug Approval Standards

Solgar Polska Accused Of Price Fixing Dietary Supplements in Poland

Evidence uncovered at the headquarters of Solgar Polska indicates the firm has since 2010 been instructing retailers to fix prices for its wide range of supplements, according to the national competition regulator. The company is now facing a full investigation and potentially a substantial fine.
Poland Dietary Supplements Legal Issues

Cosmetic CBD Has Insurance Industry Spooked: The Dope Before You Toke

Marketing CBD-containing cosmetics in today’s hazy legal and regulatory environment carries risks beyond what insurance carriers may be willing to take on. Kenneth Hegel of Cosmetic Insurance Services, a division of brokerage firm Frenkel & Company – an Epic Company, discusses the dilemma facing underwriters and criteria companies can meet to improve their insurance prospects.

Beauty Cosmetic Ingredients Legal Issues

Legalizing Marijuana Would Calm CBD Regulatory Storm – CV Sciences' MacKay

As FDA moves slow on allowing CBD as a dietary ingredient, a marijuana reform law is a near-term possibility and would cause a “nuclear shift” about cannabis regulation and sway agency's decision, says cannabidiol firm CV Sciences executive.

Dietary Supplements FDA Regulation
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The 2019 OTC Marketing Awards

Co-presented by IRI – The 2019 OTC Marketing Awards celebrated the best and brightest of the UK consumer healthcare sector and clearly demonstrated that the industry is in rude health. Read this eBook to learn more.

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Health Explore this Topic

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Latest From Health

Don’t Be Afraid To Try Something New – Q&A With GSK Marketing Exec Stephen Glynn

GSK Consumer Healthcare's engagement director Stephen Glynn gives his insight into how digital is shaking up OTC drug marketing and talks about the experiences that have shaped his career.
Leadership Ad Campaigns

German Industry Wants To Simplify 'Complicated' Switch Process

The German Medicines Manufacturers´ Association, the BAH, is calling for the country's prescription-to-OTC reclassification procedure to be simplified by removing from the process the country's Ministry of Health and Bundesrat, and empowering the medicines agency, BfArM, to make the final decision based on recommendations from the Expert Advisory Committee for Prescription. 
Health OTC Drugs

Can You Kick It? Yes You Can, With Six New Foot-Care Products In The UK

New OTC medicines for fungal nail infections and verrucas have been launched in the UK by Galderma, Reckitt Benckiser and Vemedia, while new foot-care products have also been introduced by Blistex, Epitact and Dermatonics.

OTC Drugs Launches

GSK Admits Voltaren Marketing Misled Australian Consumers, Now Facing Financial Penalty

GSK has admitted misleading Australian consumers with the marketing of its Voltaren range by claiming Osteo Gel was specifically formulated for treating osteoarthritis conditions, and was more effective than Emulgel to treat those conditions, when the two products were identically formulated. While a change to Osteo Gel's packaging has since satisfied Australia's Federal Court, GSK is still facing a financial penalty for its earlier conduct.
Legal Issues Ad Campaigns

Health And Wellness Products Trademark Review May 14, 2019

Trademarks registered and published for opposition with USPTO in Class 3 – cosmetics and cleaning Preps, and Class 5 –pharmaceuticals. Marks for vitamin, mineral and supplement products also are registered or published for opposition in both Class 3 and Class 5.
OTC Drugs Dietary Supplements

Unreliable Survey Doesn't Sink Mucinex Fast-Max 'All In One' Claim In NAD Review

RB didn't get help from consumer perception survey to support argument that "All In One" label statement is not claim the product treats all cold and flu symptoms. Council of Better Business Bureaus' division dismisses survey as faulty but approves RB's argument. NAD attorneys conclude 15- and 6-second TV and video "superhero 'movie trailer'” ads did not include "a sufficiently proximate and prominent list of symptoms" to counter "distracting features."

OTC Drugs Ad Campaigns
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Latest From Beauty

'Secrets, Secrets, Are No Fun': California’s Fragrance Transparency Bill Heads For Senate Vote

The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2019 has cleared key Senate committees, including Appropriations, and is now up for a third read on the Senate floor.

Beauty US States

Cosmetics Weekly Trademark Review: May 21, 2019

Personal-care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps.
United States Beauty

CBD Cosmetics Rush Is ‘Fast And Furious,’ But Don’t Skimp On Testing, Experts Say

Speakers at ICMAD’s regulatory workshop in New York stressed the importance of CBD testing in today’s highly uncertain climate for hemp-based cosmetics. While rigorous testing can drive up costs and slow the path to market, it also could significantly reduce chances of safety, regulatory or legal issues down the line.

Beauty Cosmetic Ingredients

Cosmetics Weekly Trademark Review: May 14, 2019

Personal-care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps.
United States Beauty

E.l.f. Shutters Its Stores, Ratchets Up Digital Marketing To Reinvigorate Brand’s ‘Superpowers’

The Oakland, Calif.-based firm is cautiously projecting net sales declines of 4% to 8% in fiscal 2020, but is confident about its strategic redirection, which prioritizes packaging redesigns, first-to-mass items and “fewer, bolder product stories” under new marketing leadership brought on board in February from Shiseido.

Beauty Sales & Earnings

Private-Equity Investors Poised To Acquire Nestlé Skin Health, Promising US Expansion

After working hard to turnaround its troubled Skin Health dermatology operation, Nestlé looks set to offload the business to a consortium of private-equity buyers. The consortium - led by EQT - have identified expansion in the US consumer health market as an immediate priority.
Deals OTC Drugs
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Wellness Explore this Topic

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Latest From Wellness

Wellness Industry News: GMP Complaint Against Confidence USA, Crown Labs Expands Again, More

FDA seeks injunction against Confidence USA; Crown Labs expands again; CHPA, PCPC say Environmental Working Group "irresponsibly misrepresents” evidence on sunscreen safety; Kratom Information & Resource Center says 92% of news about kratom published since February was ‘unfair and unbalanced’; more news.

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Red Yeast Rice History Offers Blueprint For Clearing CBD As Dietary Ingredient

Legal dispute between FDA and Pharmanex decided in 1999 could be precedent for using hemp-derived ingredients including CBD in supplements, even though CBD already has been authorized for clinical drug evaluation and for use in a drug, says attorney Miriam Guggenheim.

Dietary Supplements FDA

Glucosamine Supps For Heart Health? Large UK Biobank Study Says Yes

A large-population UK study published in the British Medical Journal has found that habitual use of glucosamine supplements may reduce the risk of cardiovascular disease events, such as heart attack, coronary heart disease and stroke.
Wellness Dietary Supplements

Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'

"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.

Prescription To Otc Switch OTC Drugs

GMO Evolution Creates Challenges For ‘Clean Label’ Supplement Marketers

Supplement and food firms should "check to see if any ingredients they use may be affected or potentially contaminated by genetically engineered bio-synthesized ingredients,” said Jim Thomas, scientist and co-founder of ETC Group. Biotechnologies have emerged to yield ingredients for clean label products with organisms raised in ecosystems developed from processes that involve genetic engineering.

Dietary Supplements Business Strategies

'Innovation' Meeting Shows FDA-Industry Gap On NDI Guidance Details Remains

Panel discussions and public comments during FDA public meeting show industry sees agency, as it stated in draft NDI notification guidances published in 2011 and 2016, is allowing little room for innovation through making new ingredients available for use in VMS products. FDA says immense growth of the VMS market since DSHEA passed shows numerous products available in US contain substances that haven't been notified to the FDA with proof showing they are dietary ingredients and are safe for use.

Dietary Supplements FDA
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Market Intelligence Explore this Topic

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Latest From Market Intelligence

Don’t Be Afraid To Try Something New – Q&A With GSK Marketing Exec Stephen Glynn

GSK Consumer Healthcare's engagement director Stephen Glynn gives his insight into how digital is shaking up OTC drug marketing and talks about the experiences that have shaped his career.
Leadership Ad Campaigns

The Dutch OTC Market In 2018: Pharmacists Not Consumer Friendly, Supermarkets Capitalize

While the Dutch OTC market grew steadily by 3.2% to €753m in 2018, according to IQVIA data, the country's self-care industry association, Neprofarm, pointed to a changing retail landscape in the Netherlands where supermarkets are grabbing market share from pharmacies. 
Health OTC Drugs

Consumer Reports Issues 2019 Sunscreen Recommendations; All Contain Oxybenzone

While acknowledging concerns about oxybenzone, Consumer Reports maintains the importance of sunscreen to help prevent skin cancer and says oxybenzone-containing offerings continue to test best when it comes to broad-spectrum protection and minimal SPF “variation.”

Beauty Health
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