OverTheCounterToday

OTC/Nutritional News From "The Tan Sheet": Advocates Refile Plan B Lawsuit; Plan B Available in University Vending Machine; Korea’s Wider OTC Access Stalls

OTC/Nutritional News From "The Tan Sheet": FDA Acts Against GMP Violator, Petition Seeks NDI Guidance Withdrawal

Happy Thanksgiving from your friends at "The Tan Sheet"! Our Nov. 28 issue will feature stories on supplement adulteration and Rx-to-OTC switch self-selection studies, as well as an interview with the CEO of Capsugel.

In the meantime, check out the latest OTC/nutritional news below.

 

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This Week In OTCs And Nutritionals: Rx-to-OTC Switch Tool, NDI Guidance Opposition, PGT Healthcare Interview

Our Nov. 21 issue takes a look at a risk/benefit assessment tool from the World Self Medication Industry group that could aid the development of Rx-to-OTC switch applications. We've also got an exclusive interview with the leaders of PGT Healthcare -- the new consumer health joint venture between Procter & Gamble and Teva Pharmaceutical Industries.

Additionally, "The Tan Sheet" this week features stories on some vociferous opposition to FDA's new dietary ingredient notification draft guidance and the government's cost estimates associated with compiling an ingredient dossier, as well as the latest on congressional funding for FDA's food safety activities.

 

Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here.

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

Elsevier Business Intelligence launches its revamped website today! Check out the new look of "The Tan Sheet," "The Rose Sheet" and other EBI publications.  

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.

 

Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here.

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Burton, Durbin Offer Divergent Views On Supplement Safety

  


In the past week, Rep. Dan Burton, R-Ind. (above left), and Sen. Dick Durbin, D-Ill., demonstrated the range of congressional perspectives on dietary supplement safety.

Burton introduced a bill Nov. 4 to move up the dietary ingredient grandfather date by more than 12 years -- from Oct. 15, 1994, to Jan. 1, 2007. The Dietary Supplement Protection Act, H.R. 3380, would give the supplement industry a reprieve from submitting potentially thousands of new dietary ingredient notifications for products that came on the market after the Dietary Supplement Health and Education Act of 1994.

"The Tan Sheet" News Roundup: Pfizer Plots Lipitor Switch, Crest NAD Case, OTC Inhaler Measure Fails

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.

Also, check out "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs And Nutritionals: Asthma Drug Switch Possibilities, J&J Consumer Comeback, AHPA's NDI Congress

 

The cover story for our Sept. 19 issue examines the possibility of Rx-to-OTC switches for asthma drugs, including GlaxoSmithKline's Advair and Merck's Singulair, once they lose patent protection.

Looking inside this week's "Tan Sheet", we report on what Johnson & Johnson is telling market analysts about the resurrection of its consumer business following 2010's recalls. There's also in-depth coverage of the American Herbal Products Association's recent NDI Congress in Chicago, at which supplement industry stakeholders emphasized the importance of a unified response to FDA's new dietary ingredient notification draft guidance.

Additionally, we've got stories on U.S. Pharmacopeia's monograph modernization initiative, an FDA guidance document on self-selection studies for OTC drugs, and what Sen. Tom Harkin has planned for securing the pharmaceutical supply chain.

Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. Click here for more information on a free 30-day trial subscription.

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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.

[“The Tan Sheet” is your weekly full-course meal with ingredients from throughout the OTC drug and nutritional product industries. Sign up here for a free 30-day trial subscription.]

This Week In OTCs And Supplements: Rumblings And Grumblings About NDI Guidance Continue

 

Industry concerns are adding up regarding the new dietary ingredient notification draft guidance released earlier this month. In the latest issue of "The Tan Sheet," industry stakeholders say the guidance sets the evidence bar too high and worry that combinations of old ingredients to create a new molecular entity could trigger NDI notification requirements. FDA stands by its earlier statement that several firms already met the burden of proof – showing it is possible.

This issue also looks closer at social media in OTC marketing and the growing momentum to once again allow consumers to pay for OTCs with pre-tax health savings accounts without obtaining a prescription.

[For more blow-by-blow coverage of the NDI guidance and other news impacting the dietary supplement and OTC industries subscribe to "The Tan Sheet." Click here for a free 30-day trial subscription.]