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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.
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.
"The Tan Sheet" this week reports on FDA's supplement enforcement priorities with a dispatch from the Council for Responsible Nutrition's recent conference. FDA's Division of Dietary Supplement Programs plans enforcement activity in the areas of new dietary ingredients, good manufacturing practices and adverse event reporting. Also from the CRN conference, a story on what retailers expect to see from supplements and OTCs in the areas of social media marketing and consumer education.
Our Oct. 31 issue keeps pace with the flurry of quarterly earnings reports. In addition to news on Procter & Gamble's planned across-the-board price increase and Perrigo's underperforming OTCs and nutritionals, we've got highlights from Bayer, Colgate-Palmolive, GlaxoSmithKline, Mead Johnson Nutrition and many other reporting companies.
As always, there's plenty more in the latest "Tan Sheet," including a look at how FDA might learn from Health Canada's revised probiotics regulations, scrutiny of Allegra's allergy relief claims, and industry's defense of spray sunscreen safety.
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.
The Oct. 24 issue of “The Tan Sheet” reports on researchers’ recommendations for sponsors of OTC switch applications based on questions FDA has asked in previous switches, as well as additional news in the OTC sector from firms including Johnson & Johnson and Help Remedies.
We also note that for the first time, FDA submitted GMP warning letters with language explaining the agency considers own-label dietary supplement marketers responsible for their contract manufacturers’ violations. Plus, we look at how Abbott Laboratories’ nutrition business gains importance with the firm’s plan to spin off its research-based branded pharmaceuticals business.
Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For information on a 30-day free trial subscription, click here.
Continue reading "This Week In OTCs And Nutritionals: Switch, GMPs, Abbott " »
The supplement industry takes one on the chin, but keeps fighting after several studies spotlight the risks of supplements and suggest additional regulation may be needed. Supplement firm Herbalife also asks FDA to meet the industry half-way in the debate about what the new dietary ingredient notification process covers.
On the OTC side, FDA and drug industry leaders brainstorm best practices to improve quality control and ways to facilitate switch at the Consumer Healthcare Products Association’s Product Quality & Operations Workshop.
This news preview 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, follow "The Tan Sheet" on Twitter and Facebook.
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 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 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 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.
Continue reading ""The Tan Sheet" Presents: OTC/Nutritional News Roundup" »
