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This Week In OTCs And Nutritionals: Perrigo Labeling Case, Pfizer Phytosterol Research, GAO Supplement AER Inquiry

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In our Nov. 14 issue, we report on a lawsuit in federal court against Perrigo that raises the question of whether federal regulations pre-empt claims made under state laws on failure to warn. At issue is whether the private labeler should have mentioned the potential for liver toxicity on an ibuprofen product.

Inside "The Tan Sheet," we look at Pfizer's research into the cholesterol-lowering characteristics of nonesterified phytosterols, as used in the firm's Centrum Cardio multivitamin. Pfizer conducted the research to support a comment to FDA arguing that nonesterified phytosterols still should be allowed to make coronary heart disease risk reduction claims, which the agency is planning to phase out.

Additionally, we've got a pair of Capitol Hill supplement stories. Sen. Dick Durbin, D-Ill., requests a Government Accountability Office investigation into FDA's collection and analysis of serious adverse event reports linked to supplements. In the House, Rep. Dan Burton, R-Ind., offers a bill to give the supplement industry an additional 12 years -- up to Jan. 1, 2007 -- of grandfathered status for dietary ingredients on the market.

There's plenty more in this week's "Tan Sheet," including an examination of European obstacles to Rx-to-OTC switch, comments to FDA from Merck and Procter & Gamble on sunscreen regulations, and quarterly sales & earnings coverage.

 

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"The Tan Sheet" Presents: OTC/Nutritional News Roundup

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: Class In Session Edition

 
“The Tan Sheet” this week reports on a GlaxoSmithKline-backed study that shows educating consumers about the safety and efficacy of nicotine-replacement therapies could lower their concerns about the products’ prices.

We also report that Pfizer would need to learn a lot about consumers’ safe self selection if the firm wants to switch its high cholesterol treatment Lipitor to OTC, and dietary supplement industry trade groups want to learn more about how FDA will calculate the user fees authorized by the Food Safety Modernization Act.

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Education About NRT Safety Overcomes Smokers’ Cost Barrier – Study
Drug firms could educate consumers about the safety and efficacy of nicotine-replacement therapies to show the products’ value, according to recent research.

Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles
Pfizer would face major hurdles in research on consumers’ safe self-selection for FDA to approve an OTC switch of the firm’s cholesterol treatment Lipitor.

Supplement Industry Questions FDA's Calculations For Food Safety User Fees
Good manufacturing practice compliance becomes more critical for dietary supplement firms as FDA sets the first user fees to cover agency costs for follow-up inspections of facilities and imports and work on mandatory recalls.

This Week In OTCs And Nutritionals: Table Of Contents

 
The July 25 edition of "The Tan Sheet" continues coverage of the OTC industry's biggest story of the past two years -- Johnson & Johnson's OTC manufacturing issues and recalls. Our cover story looks into the report produced by a special committee of J&J directors, in response to a shareholder lawsuit, that identifies root causes behind the company's quality control lapses. On the inside of this week's issue, we take a look at J&J's second-quarter results and the encouraging signs for its consumer business.

"The Tan Sheet" also has follow-up coverage of FDA's new dietary ingredient notification draft guidance -- what it might mean for probiotics supplements and how FDA might go about enforcing the guidance.

Of course, there's plenty more as well, including news from Procter & Gamble, Abbott Nutrition and the U.N.'s Codex Alimentarius Commission.

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TOP STORIES 

J&J Directors Find Root Causes But Little Blame For OTC Quality Issues
A report by a Johnson & Johnson special committee finds organizational and middle management changes at the firm were the root causes of manufacturing and quality control lapses in the OTC drug business.

International Panel’s Nutrient Value Guideline May Boost Supplement Exports
Dietary supplement firms soon could export products internationally without having to reformulate to accommodate local nutrient value regulations.  

NDI Notification Enforcement Ramp-Up Likely To Target “Low-Hanging Fruit”
Legitimate supplement firms should not need phased-in enforcement of the new dietary ingredient notification regulations, says Anthony Young, general counsel to the American Herbal Products Association.  

OTC/Nutritional News Roundup: New Wrinkles Edition

 
Firms develop wrinkle and pimple creams as more adults seeks treatment for acne…Gerber adds a new wrinkle to the infant formula market with the first qualified health claim… South Korea health agency opposes regulatory wrinkle allowing wider access to OTC drugs…

[Keep up with all the new wrinkles in the OTC and nutritionals industries, including the latest products for preventing wrinkles, in "The Tan Sheet." Click here for a free trial.]

This Week In OTCs And Nutritionals: Don't Call It A Shutdown

While most in Washington were on the edge of their seats last week following the near government shutdown, all of us at "The Tan Sheet" were following another big D.C. event: the annual conference of the Food and Drug Law Institute.

Our April 11 issue features exclusive coverage from FDLI, including what Janet Woodcock, director of FDA's drug center, thinks about the future of Rx-to-OTC switches and a law professor's take on the the Supreme Court's decision regarding Matrixx Initiatives’ failure to disclose Zicam adverse event reports to investors.

Outside of the FDLI conference, this week's "Tan Sheet" also looks at the significance of Pfizer's Capsugel divestment and the potential OTC fallout from FDA's consumer warning on benzocaine.

 

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TOP STORIES

CDER Director Sees Behind-The-Counter Switches As Best Bet
FDA drug center chief Janet Woodcock says behind-the-counter switches would be the most effective method to make Rx drugs available without prescriptions, particularly to help treat chronic conditions.

EU Seeks Standard OTC Packaging And Labeling Across Member States
European Medicines Agency recommendations released April 1 look to revamp the information provided on labeling and packaging for nonprescription drugs authorized under the agency's centralized procedure.

Freed From Pfizer, Capsugel May Find More Market Opportunities
Pfizer's divestiture of Capsugel moves the gelatin capsule manufacturer out from under pharma ownership, potentially opening a door to more business.

This Week In OTCs And Supplements: Every Cloud Has A Silver Lining

 

This week "The Tan Sheet" finds the silver lining in FDA's rejection of Ovos Natural Health's citizen petition to classify homotaurine as a new dietary ingredient and a strongly (mis)worded FDA warning letter to Tennessee Scientific.

In the Ovos case, FDA's refusal to recognize Vivimind as a supplement is good news for the industry because it means the agency likely could not justify applying to NDIs that underwent the investigational new drug process a controversial provision that prohibits the sale of foods with substances that underwent publicly disclosed clinical trials, according to a leading food and drug law attorney.

Likewise, an "incorrect version" of an FDA warning letter that erroneously cited FTC enforcement and triggered a storm of speculation "is good news in the sense [that firms] shouldn't have to worry as much about one agency enforcing the other's laws," another attorney notes.

The latest issue of "The Tan Sheet" also weighs the pros and cons of OTC birth control, tracks recent acquisitions and considers Korea's OTC market, among other topics.

["The Tan Sheet" is your source for the most up-to-date news and in-depth analysis of the OTC pharmaceutical and nutritional industries. For more information on a free 30-day trial subscription, click here.]

OTC/Nutritional News Roundup

In this week's news roundup, brought to you by "The Tan Sheet":

Obama's budget request adds to FDA's user fees ... Walgreens kicks off store brand ad campaign ... U.K. agency sounds alarm on "Herbal Xenicol" ... FDA, U.S. Customs team up on counterfeit supplements

FDA Roundup: Livin' La Vida Loko

FDA is in the headlines this week for its enforcement actions against the makers of the infamous Four Loko and other alcoholic energy drinks. It's not the first time such products are under scrutiny -- we noted the market withdrawal of Sparks beer/caffeine combo in 2008 after several states sued MillerCoors Brewing Co.

Despite much ado about the warning letters regarding Joose, Moonshot and their ilk, there is other FDA-related news this week that we'd be remiss to overlook.

 

FDA sued over Plan B stagnation: The Washington Post blogs...

KV Pharma sinks further as exec is penalized: The St. Louis Post-Dispatch reports... 

Kava toxicity concerns need clarification: JAMA notes...

 

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