OverTheCounterToday

OTC/Nutritional News Roundup: Fireworks Edition

 
The overhead colors and explosions get the attention in firework displays, but a fuse must be lit to send each Roman candle, spinning wheel or weeping willow skyward. As Independence Day approaches on July 4, with fireworks ready in backyards, ball fields and parking lots around the country, we find some fuses lit in the OTC drug and nutritional product arenas.

J&J says no to report of joint OTC/Rx marketing, according to a VP…
Sen. Durbin wants what from dietary supplement firms? AHPA asks… 
Rhode Island ready to impose OTC sales tax, lawmakers indicate…

["The Tan Sheet" is your weekly source for all the news -- from fuse to finale -- in the OTC drug and nutritional product markets. Click here for a free trial.]

This Week In OTCs And Nutritionals: NDI Guidance Could Be Summer Blockbuster

Just when the supplement industry thought it was safe to go back in the new dietary ingredient water, FDA's top supplement official says more enforcement activity is likely once the NDI notification guidance hits theaters -- er, dockets -- as is expected next week.

But will the guidance prove a smashing success with the industry that has waited years for it? Or will it bomb? This week's issue of "The Tan Sheet" has the story.

Our June 27 edition also shines a light on what FDA thinks about spray sunscreens and checks in with several ingredient companies making moves in the functional foods arena.

 

["The Tan Sheet" is rated "E" for essential market insight covering the OTC pharma and nutritional industries. Snap up a free 30-day trial subscription here.]

 

TOP STORIES

Low NDI Notice Compliance Sets Stage For Enforcement – FDA’s Fabricant
The volume of noncompliant supplement ingredients on the market likely will prompt an uptick in enforcement after FDA releases its NDI notification guidance, which will draw attention to the problem, dietary supplement program chief Daniel Fabricant says.

FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status
FDA could exclude increasingly popular spray sunscreens from the final monograph unless firms submit sufficient safety and efficacy data, according to an advanced notice of proposed rulemaking.

Ingredient Supplier Interest In Functional Foods Shows No Sign Of Let-Up
Market research firm Mintel says the consumer market for functional foods and beverages has hit a lull, but at the product development level the segment continues expanding with new ingredients and applications.  

Times Reviews Hatch's Star Turn In Supplement Industry Support

 
The New York Times questions whether Sen. Orrin Hatch’s advocacy has hindered FDA from preventing dangerous products from reaching the market.

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.  

[For box seats to see the latest OTC drug and nutritional supplement dramas subscribe to "The Tan Sheet."  Click here for a free trial.]

FDA Strengthens Sunscreen Testing And Label Requirements

The following story runs compliments of Elsevier Business Intelligence's Health News Daily, your everyday source for the most comprehensive news and analysis covering the pharmaceutical, medical device and consumer health product industries. 

For continuing coverage of FDA's sunscreen regulations, as well as a comprehensive archive of stories addressing this issue, check out "The Tan Sheet" and "The Rose Sheet". Find more information about these and other EBI publications here.

 

FDA Strengthens Sunscreen Testing And Label Requirements

As early as June 2012, labeling for sunscreens that fail comprehensive "broad spectrum" tests or have an SPF less than 15 must include warnings that they have not been shown to prevent cancer or early skin aging, according to an FDA final rule.

Under the rule announced June 14, firms that want to claim a product decreases the risk of skin cancer or early skin aging caused by the sun must meet broad spectrum tests, which measure protection from both UVA and UVB rays.

The final rule also prohibits claims that FDA says overstate sunscreens' efficacy, such as "waterproof," "sweatproof" and "sunblock," and assertions that the product works instantly or for more than two hours without reapplication.

This Week In OTCs and Nutritionals: Overseas Edition

 

"The Tan Sheet" staff needed virtual passports to report on the latest OTC and nutritional developments overseas this week. In the U.K., regulators require labeling changes for children's paracetamol (called acetaminophen in the U.S.) to reflect more bands of weight-based dosing. Back in the U.S., the Council for Responsible Nutrition tells the Department of Commerce the European Union's supplement health claims regulations may violate World Trade Organization treaties, while Federal Trade Commission manager Richard Cleland notes the agency does not look highly on studies done overseas to substantiate supplement health claims.

Be sure to check in with "The Tan Sheet" next week for coverage of the European Self-Medication Industry's conference "A New Treaty For Self-Care," held last week in Rome. Check in to see in which regions the OTC market is flourishing and why.

["The Tan Sheet" is your source of OTC and nutritionals information at home and abroad. Click here for a free trial.]

 

OTC/Nutritional Road Warriors

"The Tan Sheet's" dedicated team of reporters and editors is hitting the road this month to get up close and personal with the biggest newsmakers from the OTC pharmaceutical and nutritional industries.

This week, we're covering the Orange County Regulatory Affairs Discussion Group's annual education conference, sponsored jointly with FDA's Los Angeles district office. While Commissioner Margaret Hamburg is only appearing via pre-recorded video, there are plenty of live dietary supplement discussions on the agenda. Daniel Fabricant, director of the agency's Division of Dietary Supplement Programs, will speak June 9 on current agency priorities and activities surrounding supplements.

This Week In OTCs And Nutritionals: A Lotta Ins, A Lotta Outs, A Lotta What-Have-Yous

 

The revolving door to the OTC and supplement industries is spinning again as several firms usher in new acquisitions and others look for an exit. Schiff Nutrition and Nestle expand in the digestive health area with acquisitions, while analysts handicap the likelihood that firms such as Germany's Merck KGaA, Merck & Co. and Pfizer, could spin off their consumer divisions.

Other moving pieces to track include possible revisions to the pediatric cough and cold monograph, FDA's warning letter close-out program and how the agency identifies high- and low-risk imports.

(Let "The Tan Sheet" help you keep all the strands in your head. Click here for a free 30-day trial.)

House Appropriators Push For Revised Pediatric Cough/Cold Labels
House appropriators want FDA to propose by Dec. 31 revised labeling for OTC pediatric cough and cold products that addresses safety and efficacy concerns

Consumer Division Divestments Would Spotlight Firms’ Value – Analysts
Germany’s Merck KGaA could join the ranks of firms like Pfizer potentially looking to leave the consumer health care product business, market analysts argue

Schiff Nutrition Gains Probiotics Ingredient, Brands From Ganeden
Schiff Nutrition International makes a $40 million investment in probiotic supplements by acquiring worldwide exclusive rights to the GanedenBC30 strain and a pair of consumer probiotics brands

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.]