OverTheCounterToday

This Week In OTCs And Nutritionals: A Cold Front Chills Industry

The temperatures outside are dropping, but Jack Frost is not responsible for the cooling relationship between FDA and the dietary supplement industry. Trade groups respond icily to new dietary ingredient notification draft guidance that they say contravenes the Dietary Supplement Health and Education Act. Most groups agree FDA should rewrite the guidance, but “The Tan Sheet” combs through individual comments to highlight the finer points.

HHS Secretary Sebelius also sent a chill through the drug industry when she blocked Teva Pharmaceutical Industry’s attempted full OTC switch of emergency contraceptive Plan B. We look at why Sebelius overrode FDA’s recommendation to make the pill available OTC to all females of childbearing age, and analyze the potential impact the interference could have on future switch attempts and the potential creation of a third drug class.

We also look at FDA’s enforcement priorities for the New Year and its progress on foreign food facility inspections.

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This Week In OTCs And Nutritionals: Silenor On Switch Path, FTC Claim Standards, New Supplement Trade Group

 
"The Tan Sheet" examines the Rx-to-OTC switch potential of Somaxon Pharmaceuticals' Silenor (doxepin), a sleep aid that could launch OTC in five to seven years, pending safety and efficacy studies. Procter & Gamble has co-marketing rights to Rx Silenor through the end of 2011 and appears a likely candidate to ultimately license a nonprescription version from Somaxon.

Our Oct. 10 issue has coverage from the National Advertising Division's annual conference, at which Federal Trade Commission consumer protection official David Vladeck spoke on claim substantiation standards. "The Tan Sheet" this week also takes a look at the nascent dietary supplement trade association formed by Jarrow Formulas President Jarrow Rogovin, who promises "more creative" and more aggressive industry representation.

Additionally, we've got stories on Garden of Life's latest faceoff with FTC, Matrixx Initiatives' settlement with shareholders over its private-equity buyout, and what's holding up FDA's food safety user fees program.

 

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"The Tan Sheet" News Roundup: Pfizer Delays Nutritionals Sale, Ron Paul Supplement Bill, Pharmavite In 'Bama

 

 
 

This news roundup is brought to you by "The Tan Sheet," your source for the most in-depth news and analysis from the world of OTC drugs and nutritionals. For information on a 30-day free trial subscription, click here. 

 

This Week In OTCs And Nutritionals: Tough-Pill-To-Swallow Edition

As the dietary supplement industry continues digesting FDA’s expectations that significantly more new dietary ingredients notifications are necessary, the agency also dishes out some news on serious adverse event reports that the industry could find hard to swallow, this week’s issue of “The Tan Sheet” reports.

FDA’s Division of Dietary Supplement Programs suggests that supplement firms should be submitting to the agency more of the reports on adverse events the firms are receiving from consumers and other parties. Meanwhile, industry champion Sen. Orrin Hatch makes clear he agrees with stakeholders that FDA’s draft guidance on NDI notifications oversteps regulations established by DSHEA.

In this issue, we also report on an attorney’s caution about functional food advertising claims due partly to increased enforcement in the area.

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This Week In OTCs and Nutritionals: Center Stage Edition

 
In this week's issue of "The Tan Sheet," we lift the curtain on FDA's final rule for testing and labeling sunscreen products and on the agency's proposed rule to cap sun protection values at 50 or 50+ so as not to mislead consumers about the clinical benefit of sunscreens with higher SPF values.

Meanwhile, we shine a spotlight on FDA's warning letters to dietary supplement firms about good manufacturing practices violations. On the international stage, we report on Central and Eastern Europe driving OTC sales growth on the continent and on South Korea liberalizing its OTC access reg.  

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This Week In OTCs And Nutritionals: Beyond A Shadow Of A Doubt Edition

FDA advisory committees May 18 made clear their preferences on each question the agency posed on dosing directions and labeling for pediatric single-ingredient 
acetaminophen products and on whether a single concentration is needed for solid oral dosage forms. 

“The Tan Sheet” this week makes clear the advisory panel members’ concerns about the safety of children’s acetaminophen products. This issue also leaves no question that industry stands behind the products' safety.

Additionally, we report the development of OTC drugs based on probiotics might require a regulatory system more receptive to research on the microorganisms' use as therapeutic ingredients, and on Procter & Gamble and Colgate-Palmolive touting the growing strength of their branded products over generics.

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Today's Bill Of Fare: Regulatory Enforcement

 
Over the weekend, the New York Times offered up a menu of stories on health claims for foods. The fare included a main course here about health benefit claims in products across numerous categories of functional foods, and an après-dinner treat here on the use of melatonin in brownies and other desserts, which may run afoul of FDA's regulations on using dietary supplement ingredients in foods.

“The Tan Sheet” also has reported on FDA’s regulation of health benefit claims for food products, here, and on the agency’s enforcement against food products containing ingredients common in supplements but unapproved as food additives, here. 

["The Tan Sheet" serves a weekly feast of nutritional product and OTC drug news and analysis. Click here to sign up for a free 30-day trial.] 

-- Malcolm Spicer (m.spicer@elsevier.com)

This Week In OTCs And Nutritionals: Back To The Future Of OTC Drugs

 
This week's issue of "The Tan Sheet" looks at a number of potential turning points and future implications for OTC drugs. Our cover story goes inside Acura Pharmaceuticals' "extraction-resistant" pseudoephedrine, which the firm believes could transform the category of decongestants fueling the methamphetamine controversy in many states.

Our May 16 edition previews the May 17-18 FDA advisory committee meeting, at which the Pediatric and Nonprescription Drugs panels will mull the future of dosing, labeling and packaging for children's acetaminophen products. We'll have more coverage of the meeting this week in "Health News Daily" and in our May 23 issue.

Additionally, "The Tan Sheet" visits with members of the Health Choices Coalition, which seeks to repeal the provision of health care reform limiting coverage of OTC drug purchases under tax-exempt accounts. Future health care costs could grow if consumers have less incentive to buy OTCs, coalition members warn.

Finally, we look at what diagnostic technology and personalized medicine could mean for the future of nonprescription drug development and Rx-to-OTC switches. It will take some ingenuity on the part of industry to make that future a present reality.

 

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This Week In OTCs and Nutritionals: Magic Tricks Edition

Ladies and Gentlemen, READ “The Tan Sheet” this week and WATCH EUROPEAN OTC EXPERTS attempt to pull the ELUSIVE REAPPEARING CONSUMER out of a hat! SEE HELP REMEDIES TRANSFORM venerable OTC ingredients into STYLISH NEW PRODUCTS! And WITNESS a judge SAW IN HALF a qualified health claims suit against FDA!

(“The Tan Sheet” works its magic every week. To conjure up a free trial, wave your cursor here.)

OTC/Nutritional News Roundup: Acai Weight-Loss Crackdown

It was never quite clear how a high-calorie fruit like the acai berry became associated with weight loss, but the Federal Trade Commission isn't taking such dubious marketing lying down, as you can see in this week's news roundup.

FTC looks to stop the presses on acai "reporters" ... J&J pushes back full OTC relaunches to 2012 ... Court ruling deems some FDA claim requirements unreasonable