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Ranitidine Recalls Begin In Europe As Regulators Take Action

OTC products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs.With investigations underway worldwide, regulators across Europe are split into two camps: immediate action or wait and see.
Product Recalls Drug Safety Europe

GSK Proposal For Novel Delivery NRT Leaves FDA Doubting 'Real World' Efficacy

In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."

OTC Drugs FDA Advisory Committees

CVS Reformulating Own-Brand Sunscreens Without Alleged Coral Killers

“CVS Pharmacy is highly attuned to our customers’ evolving needs and their desire for products that are more sustainable while still being efficacious,” says CVS Health’s George Coleman, senior vice president of merchandising. The retailer is committed to eliminating oxybenzone and octinoxate from CVS-branded sunscreens with SPFs less than 50 by the end of 2020.

Retail Business Strategies Health

Spotlight On Rx-To-OTC Switch

High-Dose Statins Could Go OTC In UK

The NHS wants to make high dose statins available OTC in the UK and will work with regulators and industry to make it happen. Such a switch could open up a whole new consumer health category in the country, moving the industry into treatments for chronic conditions. 

Prescription To Otc Switch United Kingdom


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Latest From Health

GSK And Perrigo Issue Recalls In Sweden After Metal Staple Found In Rectal OTC

A metal staple found in GSK's Alvedon children's pain relief product in Sweden has prompted a recall which also encompasses Perrigo's Panodil brand.
Product Recalls OTC Drugs

RB Targets UK’s Hedonistic ‘Generation Z’ With Ironic Gaviscon Campaign

Reckitt Benckiser extends its "Night Labs" Gaviscon campaign aimed at UK 20-something heartburn sufferers with two new tongue in cheek videos.
Health OTC Drugs

NDAC Recommendation To Approve GSK's Mouth Spray NRT Comes With Caveats

No more than three votes decided the panel's recommendation on each FDA question, and members in the prevailing majorities explained they made their votes with reservations. Potential use by young consumers and confusion by adult users in following the label instructions were primary concerns for all panel members.

International United States

Ranitidine Distribution Stops In Canada As Regulators Assess Contamination Threat

Health Canada asks ranitidine H2 blocker firms to halt sales until it gathers more information on NDMA contamination, which may form due to the drug’s instability. At least one marketer, Sandoz, also is recalling its ranitidine products in both Canada and US.

Europe Canada

UK Rx-To-OTC Switch Incubator Gets Angel Investment Boost

UK start-up Maxwellia's "switch-in-a-box" pipeline receives a boost with BioCity angel investment. 
Health OTC Drugs

With Novel NRT Proposal, GSK Includes Novel Labeling: 'Quick Start Guide'

Results of both its clinical trials showed significantly higher rates of smoking abstinence, but GSK adds first labeling for an NRT formatted as a Quick Start Guide and makese other label changes "to further assist consumers in how to use the spray dispenser." Similarity of mouth spray formulation's safety profile to other OTC NRTs is a key point in GSK's proposal.

OTC Drugs Advisory Committees
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Latest From Beauty

NSF International Launches Hemp/CBD Testing Services

The Ann Arbor, MI-based testing and certification organization currently can analyze hemp-derived products for 12 cannabinoids, including THC, THCA, CBD and CBG, as well as impurities and harmful microbes, and certify offerings to USDA organic standards, among other services announced 18 September. NSF Director of Applied Research Jesse Miller discusses.

Beauty Wellness

California Safer Products Reg Produces Mixed Bag Of First-Time Alternative Analysis Findings

The California DTSC has issued a notice of deficiency for the first preliminary alternatives analysis report submitted under the Safer Consumer Products regulation. That report does identify a possible replacement for methylene chloride use in paint strippers, in contrast to an abridged AA report from makers of spray polyurethane foams that claims there is no viable alternative for unreacted methylene diphenyl diisocyanates.

Beauty Regulation

Cosmetics Weekly Trademark Review: Sept. 10, 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 Trademarks

Industry Braces For Holiday Tariff Impacts As US-China Trade War Continues

“With some products facing tariffs as high as 30%, many businesses will have no choice but to pass along those costs to consumers,” an industry coalition called Americans for Free Trade asserted in an August letter to President Donald Trump in response to proposed escalations of tariffs on Chinese goods. “Price increases will likely hit shoppers just as they are making their holiday purchases,” the group noted.

United States China

FTC Scores Preliminary Injunction Against ‘Free Trial’ Scam, Another Case That Could Test Agency Authorities

The US Federal Trade Commission’s authority to secure permanent injunctions against defendants and obtain penalties for misconduct under FTC Act consumer protection provisions has taken hits in federal appeals courts of late. But for now, it is business as usual for the FTC in California federal court where it just won a preliminary injunction against alleged beauty and dietary supplement “free trial” fraudsters.

United States Advertising, Marketing & Sales

Eldest Kardashian Sis Launching CBD Serum With Hora Skincare

Kourtney of the “Keeping Up With” clan has partnered with Hora Skincare to launch Hyaluronic Halo + CBD Serum. Announced 6 September, the $50 product will be available exclusively through Kardashian’s Poosh lifestyle platform.

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Latest From Wellness

Patience Wins The Race: TTS Pharma's CEO On Bringing The First Legal CBD Oil To The UK Market

TTS Pharma wants to be the first to launch a legal CBD oil onto the UK wellness market. TTS CEO Mark Tucker explains how his firm's CBD is produced according to strict standards and can provide a model for future regulation. 
Wellness Dietary Supplements

NSF International Launches Hemp/CBD Testing Services

The Ann Arbor, MI-based testing and certification organization currently can analyze hemp-derived products for 12 cannabinoids, including THC, THCA, CBD and CBG, as well as impurities and harmful microbes, and certify offerings to USDA organic standards, among other services announced 18 September. NSF Director of Applied Research Jesse Miller discusses.

Beauty Wellness

HBW Regulatory Roundup: Spiked 'Vitamin C' Found, SC Johnson Facility GMP Problems, AHPA Labeling Guidance

Fitoterapia USA recalls 190,000 bottles of Metro Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement tainted with tadalafil; FDA sends GMP warning letter to SC Johnson facility making antimicrobial hand soaps ; and AHPA revises its herbal supplement labeling guidance.

FDA Recalls

Bayer R&D Center To Uncover Chinese Insights

A new dedicated R&D facility for Bayer Consumer Health in China will enable the firm to “quickly take the pulse of the market” and transform demand into innovative products.

Innovation China

Safe Level For CBD As Dietary Ingredient? FDA Continues Data Review

Associate commissioner Lowell Schiller's comments at recent trade group regulatory conference mark agency's first public statement on likely direction on CBD's use in food, supplements. Potentially allowing CBD's use also is making FDA "think about whether we have the tools and resources we need to take this on," Schiller said.

Dietary Supplements Regulation

Next CBD Product With False Claims Gets FTC Investigation, Not A Warning Letter

"Warning letter phase is over ... We will be opening investigations and we will target companies making disease claims for CBD products," says FTC attorney Rich Cleland. Agency also looking to hold retailers responsible for third-party vendors' false claims.

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Latest From Market Intelligence

Sanofi’s Alan Main On Tapping Into Millennials' Self-Care Demand

Wellness, access to credible information from healthcare professionals, and convenience are the three most important considerations of millennials when approaching self-care solutions, says Sanofi's Alan Main. By embracing smart technology, e-commerce, data-led solutions such as video consultations and new, innovative products, industry can seize the opportunity provided by this new generation of health-conscious, tech-savvy consumers.

Health Market Intelligence

Omega-3 Supplements For Depression? Major Study Says Yes

Omega-3, folate and amino acid supplements are an effective additional treatment for number of mental health conditions including depression and bipolar disorder, show the results of a major study.

Europe Asia Pacific

CBD Pollinating New Beauty Categories With Cannabis Cachet: Sunscreens, Deodorants And More

Cannabidiol (CBD) is spreading from therapeutic skin care to deodorants, sunscreens and makeup products as companies race to meet consumer demand despite regulatory uncertainties and potential legal pitfalls.

Beauty Cosmetic Ingredients
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