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.

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.

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. 

"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.

White House budget request published March 11 proposes a $643m increase in FDA's total FY 2020 funding, with $281m of the increase from FY 2019 in user fees and $362m from the agency's budget authority. Request includes OTC monograph user fees again, increased by $6m.

Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.

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.

P&G, Church & Dwight and Clorox executives say firms are looking to add brands to portfolios. P&G's developing assets through a brand creation project; C&D seeks top brands, largely in non-US markets; and Clorox looks for opportunities in select ‘spaces’ in US health, wellness and personal care.

Moberg had been expanding its OTC topical and nutritional supplement portfolio while also continuing trials for Rx ingredients including its MOB-015 formulation of terbinafine indicated for fingernail and toenail fungus. But $155m agreement with two investment groups will complete Moberg's divestment of consumer health brands and make it dedicated to R&D, regulatory matters and business development.

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.

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.

NCI's Sharpless named acting FDA head; Mannatech trims loss as costs grow; Nilo drinks to avoiding hangovers; Daoust leads Soylent Nutrition development, innovation; Viactim in taller, narrower package; Revel Energy made with Nitrosigine; and Thorne has at-home tests for additional concerns.

RB's Health business failed to keep pace with market growth in 2018, with the firm admitting its mindset in Europe "needs to change." The UK-based consumer-goods giant spent the 12 months working on its RB 2.0 restructuring program, which will give it the option to separate into two independent companies focusing on Health and Hygiene by 2020.

France's food supplements market enjoyed broad-based growth across key categories in 2018, driven by consumer demand for natural alternatives to conventional medicine. Over the 12 months, Pileje overtook Arkopharma as the dominant player in market, as its leading probiotics brand, Symbiosys, flew off the shelves.

Herbalife announced following close of trading on US exchanges that former CEO and current Chairman Michael Johnson returns as interim chief following Richard Goudis' resignation.The firm, which has yet to schedule the release of its 2018 fourth-quarter results, said Goudis’ exit "pertains to comments which recently came to light" he made prior to becoming CEO in 2017.

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. 

USPlabs executives, others plead guilty to felony charges stemming from marketing unsafe products labeled as supplements but containing DMAA and linked to hepatitis. Blackstone Labs and other firms indicted on felony charges following FDA investigation for marketing DMBA-containing products. "It's all very welcome news, but I'm not sure this is going to change the overall environment," says Pieter Cohen, a physician who advocates for tighter regulation of supplement manufacturing and marketing.

District court erred in dismissing FTC complaint that Prevagen marketer Quincy Biosciences used deceptive representations in ads, Second Circuit says in long-awaited order. FTC and New York attorney general, along with advocacy group TINA, criticize Quincy's post hoc data analyses finding "false positives."

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.

NCI's Sharpless named acting FDA head; Mannatech trims loss as costs grow; Nilo drinks to avoiding hangovers; Daoust leads Soylent Nutrition development, innovation; Viactim in taller, narrower package; Revel Energy made with Nitrosigine; and Thorne has at-home tests for additional concerns.

GSK, Pfizer, HRA Pharma and Mentholatum all enjoyed a particularly fruitful evening at the OTC Marketing Awards 2019. J&J, P&G and RB were also among the winners at a celebration of the best and brightest in the UK consumer health market. 

GSK, Pfizer, HRA Pharma and Mentholatum all enjoyed a particularly fruitful evening at the OTC Marketing Awards 2019. J&J, P&G and RB were also among the winners at a celebration of the best and brightest in the UK consumer health market. 

District court erred in dismissing FTC complaint that Prevagen marketer Quincy Biosciences used deceptive representations in ads, Second Circuit says in long-awaited order. FTC and New York attorney general, along with advocacy group TINA, criticize Quincy's post hoc data analyses finding "false positives."

Colgate test markets its first direct-to-consumer retail program with a tooth-whitening product available by subscription sales, says incoming CEO Noel Wallace. Program not expected to be “huge-scale opportunity” but to help accelerate innovation and better understand consumers.

The Federal Trade Commission is accustomed to seeking permanent injunctions (and monetary penalties) from companies for past violations under Section 13(b) of the FTC Act, which it contends is an invaluable deterrent to bad behavior. However, the Third Circuit says FTC’s interpretation of the section’s provisions is an untenable stretch of statutory language.

By the positioning of a pack shot of its eponymous glucose supplement in a recent advertisement, Dextro Energy had implied the product could deliver an instant energy boost - which it was not authorized to do, ruled UK watchdog ASA. 

Serious adverse events accounted for less than 1% of 41,121 adverse events reported to two supplement firms over 2.5 years, with weight loss agents and products for glycemic management accounting for majority, says a study by regulatory compliance consultants and CRN executives.