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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

AESGP Conference Round-Up: Digital Disruption, Med Device Worries And The Benefits Of Switching

Speakers from the EMA and European Commission, as well as Pfizer and HRA Pharma, debated at the AESGP's Regulatory Conference the ongoing digital transformation of the European consumer healthcare market, the latest developments in the implementation of the new medical devices regulations, and the best ways to encourage Rx-to-OTC switching across the EU.
Europe Health

OTCs Under Threat In Europe: Calls To Reverse-Switch Codeine And Others In Poland And Ireland

Poland's ministry of health is calling for codeine, dextromethorphan and pseudoephedrine to be reverse-switched from OTC to prescription status in response to abuse of the drugs by adolescents. At the same time, an academic paper argues Ireland should restrict codeine to prescription-only sale to combat an addiction epidemic "verging on eruption."
Prescription To Otc Switch Poland

Regular Aspirin Use To Prevent Cardiovascular Events Not Advisable For Most Patients – ACC/AHA Guidelines

Aspirin should be used very selectively in the primary prevention of artherosclerotic cardiovascular disease, according to new guidelines from the American College of Cardiology and American Heart Association. While certain higher-risk adults may benefit from regular, preventative aspirin use, those over the age of 70, and any at increased risk of bleeding, should explore lifestyle changes, the groups say.

Health Cardiovascular

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

AESGP Supports European Commission On Environment

European self-medication association AESGP is one of several European pharmaceutical industry bodies to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.
Europe Regulation

Zur Rose Steams Ahead With Acquisition-Led Expansion Amid Investor Concerns

Zur Rose adds French online retail platform Doctipharma as two board members resign over “differences of opinion” with regards to the firm's growth strategy.

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Latest From Beauty

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

Cosmetics Weekly Trademark Review: March 5-March 12

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.
Beauty Consumer

P&G Innovates Around Water Challenges With Hair Care In South Africa, Liquid-Free DS3

P&G’s introduction of Waterless hair care in South Africa, where water is a precious commodity, marks the first new retail hair-care brand for the firm in four years. Meanwhile, liquid-free DS3 shampoo, body wash and other personal-care swatches, available now for pre-order, support P&G’s sustainability goals while representing attractive cost efficiencies.

Beauty Business Strategies

Industry Cautions FDA To Avoid ‘Overinterpreting’ Cosmetic Allergy Survey Results

In a March 5 statement, FDA Commissioner Scott Gottlieb included labeling disclosure of known cosmetic allergens among elements that could be included in a modernized system for cosmetics oversight. The agency’s planned consumer survey, designed to assess “allergy to cosmetics,” could help to inform exploratory steps in that direction.

Beauty Regulation

Claire’s Caves, Recalls Makeup Products Following FDA’s Asbestos Finding

The jewelry and cosmetics retailer announced March 11 that it is voluntarily recalling selected lots of three makeup products due to the “possible presence of asbestos fibers.” FDA issued a safety alert the previous week that has made Claire’s the latest poster child for cosmetics regulatory reform.

Beauty Recalls
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Latest From Wellness

FDA Sets DSHEA Modernization Meeting, Warns Latest Firm On Drug Claims

FDA advised Hanna’s Herb Shop to discontinue drug claims for more than a dozen Kroeger herbal supplements, including “decrease dementia” or tackle “hypertension.” Separately, agency sets a date for its “Responsible Innovation” meeting for regulating the vitamin, mineral and supplement industry.

Dietary Supplements Regulation

FDA Budget Request Signals Importance Of Boosting Food Safety Programs

"You begin to see FDA telegraphing that this is important. That was lacking in the past two budgets," said Mike Greene, Council for Responsible Nutrition's chief congressional liaison. White House's budget request recommends $67m increase from FY 2019 to $1.4bn for FDA's food industry programs in CFSAN, which includes the Office of Dietary Supplement Programs, and for the Office of Regulatory Affairs' related field activities.

Dietary Supplements Regulation

German Industry Urges Progress On Botanicals

Germany's BPI is warning consumers to be wary of unapproved health claims made by botanical foods and supplements.
Germany Wellness

Wellness Industry News: Rain Forest In US, Napa Hills Resveratrol Sparkle, More

Peru's Ran Forest launches in US; Rebbl Collective takes on climate change, human trafficking; Napa Hills sparkles with resveratrol; more Forslean in Le-Vel's Thrive DFL; LeanLife expands testing pact with Ecovatec; and PureFormulas deploys Linc Global e-commerce tech.

Dietary Supplements Advertising, Marketing & Sales

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

Zentiva Set To Acquire Romania's Solacium

Zentiva has signed its first acquisition after it was carved out from Sanofi last year to become an independent company, entering into a shared purchase agreement with Siyiara to acquire Romania-based food supplement and OTC medicines producer Solacium.
Deals Romania
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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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