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Cannabis Industry Taking Legal Action Against EU Regulators Over CBD Novel Food Classification

The Cannabis Trades Association UK has initiated legal proceedings to challenge the European Commission's recent decision to classify CBD as a novel food. Meanwhile, the UK government has released an official response to the EU's decision. 
Dietary Supplements Legal Issues Europe

FDA Reprimands Snake Venom Seller For Pain Claims Amid Opioid Crisis

Nutra Pharma’s Nyloxin claims to relieve cancer pain and potentially help treat opioid addiction, among others, mark its products as unapproved new drugs, FDA asserts in a warning letter that reflects its homeopathic enforcement approach proposed in late 2017.  “Health fraud scams like these are inexcusable,” says FDA Commissioner Scott Gottlieb.


Wellness Advertising, Marketing & Sales Commercial

Industry Groups To Request FDA Rulemaking Deferrals For Sunscreen Ingredients In Question

Trade groups PCPC and CHPA say they likely will request that FDA defer further rulemaking on sunscreen ingredients that require additional data to retain their GRASE designations under the agency’s proposed rule for a final OTC sunscreen drug monograph, issued in February. For now, the associations are asking for an extension of the allotted comment period beyond May 28, 2019.

FDA Regulation Health

Kratom Industry Group Has First Qualifier For Its GMP Standards Exceeding FDA's

Online retailer and supplement brand Kraken Kratom is first business American Kratom Association recognized with its GMP Qualified Vendor status. But, FDA reiterates kratom should not be used in supplements until an NDI notification is submitted showing a reasonable expectation of safety for its intended use, and DEA still has pending a proposed order to schedule kratom constituent ingredients as controlled substances.

Dietary Supplements Regulation FDA
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German OTC Market Roundup 2018

It’s been another interesting year for the German OTC market. Read this new report which represent only a fraction of the German coverage in HBW Insight. Topics include, Green scrips growing steadily, German mail-order threat rises and much more.

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Latest From Health

European OTC Results Round-Up: Alliance Pharma, Boiron and Ipsen

UK-based Alliance Pharma reported a good year for its OTC business in 2018, while French players Boiron and Ipsen endured a more difficult 12 months.
Sales & Earnings Europe

EMA’s Frias Defends EU Centralized Switch Procedure Despite Only Delivering Four Reclassifications In 10 Years

Despite delivering only four switches in 10 years, the European Union’s centralized switch procedure was defended by the EMA's Zaide Frias at AESGP's March regulatory conference. Frias pointed to the recent success of HRA Pharma's EllaOne, to the role of pharmacists in driving switches and to the possibility of an OTC Expert Forum as ways forward for the procedure. 
Health OTC Drugs

CBD On OTC Industry Radar As Regulatory Questions Cloud Runway

With US market of hemp- and CBD-containing supplements and food booming, likelihood is growing products made with ingredients will gain approval in the country to be marketed with consumer health indications, said consumer health business executives during a panel discussion at CHPA conference. Legalization of marijuana sales and use by some states and other countries also will influence future of CBD use in US consumer health products, they say.

OTC Drugs Prescription To Otc Switch

Sanofi Partners With Colombian Tech Firm Rappi To 'Transform' Healthcare In Latin America

Sanofi Consumer Healthcare is utilizing emerging digital technology to take a bigger slice of the Latin American OTC market. Through a partnership deal, e-commerce and delivery firm Rappi will promote and sell Sanofi's brands to consumers across seven Latin American markets. 
Digital Health Deals

In Consumers' Self-Care Drive, OTC Firms See Platform For Boosting Industry Trust

Influencing consumers with facts about health care topics frequently littered with inaccurate advice from non-expert social media sources requires having trust, say consumer health business executives from Bayer, J&J, Sanofi and Taisho Pharmaceutical at the Consumer Healthcare Products Association executive conference. "From a trust perspective, I think that health care is a deeply personal and emotional issue. ... it is definitely important to be fact-based," said Katie Devine, J&J's consumer self-care business global president.

OTC Drugs Prescription To Otc Switch

Health And Wellness Weekly Trademark Review March 5-19, 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.
Dietary Supplements OTC Drugs
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Skin Care Line First For New Chapter Founder Schulick, Nutraceuticals In 2020

New Chapter founder Paul Schulick will introduce skin masks, cleansers and lotions with Algatech's topical astaxanthin to maintain skin microbiome. He also plans to launch nutraceuticals once a non-compete agreement with P&G, the owner of his former firm New Chapter, expires in 2020.
Wellness Beauty

California Aware Of 40-Some Nail Products Containing Toluene As SCP Process Gets Underway

The Department of Toxic Substances Control is still in the information-gathering stage for its recently proposed Priority Product under California’s Safer Consumer Products regulation – nail products containing toluene. Alternative analyses will follow, with five possible substitutes (including water) floated by the agency currently.

US States Beauty

Women’s Voices Says Clock Hasn’t Run Down On Parabens Safety; Did CIR Call The Game Early?

Recent statements from Cosmetic Ingredient Review leadership and Expert Panel members affirming the safety of parabens, while their latest review of the ingredients is ongoing, undermine the program’s credibility, according to NGO Women’s Voices for the Earth. CIR Director Bart Heldreth responds.

Beauty Cosmetic Ingredients

Summer’s Eve Removes Three Colorants From Feminine Washes, A ‘Huge Win’ For Women’s Voices

Women’s Voices for the Earth says Prestige Brands has “quietly reformulated” Summer’s Eve products to eliminate three colorants that should not be in feminine washes, based on FDA regulations and the realities of consumer practices and women’s anatomy. Now the NGO is considering next steps.

Beauty Cosmetic Ingredients

Kids’ Cosmetics With Talc Would Require Asbestos-Free Verification Or Warnings Under Dingell Bill

Rep. Debbie Dingell, D-Mich., is taking another swing at legislation to require cancer warnings on talc-containing cosmetics marketed to children if they have not been determined asbestos-free via transmission electron microscopy to FDA’s satisfaction.

Legislation Cosmetic Ingredients

Amazon Adds Masks-Specialist Fast Beauty Co. To ‘Our Brands’ Portfolio

The mega-retailer has been quietly growing its selection of private-label and Amazon-exclusive brands, recently adding Fast Beauty Co., which targets affordable, fast-acting masks to consumers on the go.

Beauty Retail
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Latest From Wellness

Skin Care Line First For New Chapter Founder Schulick, Nutraceuticals In 2020

New Chapter founder Paul Schulick will introduce skin masks, cleansers and lotions with Algatech's topical astaxanthin to maintain skin microbiome. He also plans to launch nutraceuticals once a non-compete agreement with P&G, the owner of his former firm New Chapter, expires in 2020.
Wellness Beauty

Swisse Wellness Eyes Global Expansion After Conquering China's Supplements Market

Having cemented leading positions in China and Australia, Swisse Wellness' owners H&H Group are looking to grow the reach of the premium supplements brand across Europe and Asia-Pacific. The firm is targeting 25% growth for Swisse this year after double-digit growth in 2018. 
Dietary Supplements Business Strategies

CBD On OTC Industry Radar As Regulatory Questions Cloud Runway

With US market of hemp- and CBD-containing supplements and food booming, likelihood is growing products made with ingredients will gain approval in the country to be marketed with consumer health indications, said consumer health business executives during a panel discussion at CHPA conference. Legalization of marijuana sales and use by some states and other countries also will influence future of CBD use in US consumer health products, they say.

OTC Drugs Prescription To Otc Switch

In Consumers' Self-Care Drive, OTC Firms See Platform For Boosting Industry Trust

Influencing consumers with facts about health care topics frequently littered with inaccurate advice from non-expert social media sources requires having trust, say consumer health business executives from Bayer, J&J, Sanofi and Taisho Pharmaceutical at the Consumer Healthcare Products Association executive conference. "From a trust perspective, I think that health care is a deeply personal and emotional issue. ... it is definitely important to be fact-based," said Katie Devine, J&J's consumer self-care business global president.

OTC Drugs Prescription To Otc Switch

Health And Wellness Weekly Trademark Review March 5-19, 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.
Dietary Supplements OTC Drugs

CBD Market 'Surges' As FDA Delays Setting Regulatory Policy – NPA

FDA should formalize its internal policy on CBD enforcement or create a pathway to make it compliant for use in supplements, says NPA President Daniel Fabricant. NPA and PCPC submitted comments on FDA request for input on agency's action at ongoing United Nations meeting on drug policy.

Dietary Supplements Regulation
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Latest From Market Intelligence

Providing High Value, OTC Drugs Deserve Higher Profile In Health Care – CHPA

While Rx drug pricing is under attack by Congress, White House and consumer and public health advocacy groups, OTC drugs' value isn't gaining a higher profile. "Our health care system undervalues the contribution of our industry's products," says CHPA chief Scott Melville. Trade group conducts “Value of OTC Medicines" study for reasons including raising the profile of consumer health products in the US health care system.

Health Wellness

Romania’s OTC Market in 2018: Colds And Flu Epidemic Help Boost Sales By 14%

Romanian self-care industry association, RASCI, provides HBW Insight with an exclusive viewpoint on the country's OTC market in 2018. 

 

Health OTC Drugs

GNC, Vitamin Shoppe Not On Same Page In Solving Similar Growth Challenges

Common thread between the manufacturers and retail chain operators offering their own and other brands extends to relatively recent executive suite shakeups following extended stretches of declining sales growth. GNC reported nearly $70m net income for 2018 after two years of net losses and Vitamin Shoppe trimmed its loss by more than $200m from 2017 to $12.1m.

Dietary Supplements Business Strategies
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