OverTheCounterToday

It's Ba-aack

FDA reminds the industry that OTC drug and dietary ingredient combo products are unapproved new drugs in its latest warning letter, this time going to Procter & Gamble. The letter, dated Oct. 29 and announced Oct. 30, addresses P&G's Vicks DayQuil Plus Vitamin C and NyQuil Plus Vitamin C products, both marketed for cold and flu symptoms.

A warning letter also concerning those products was posted recently on FDA's Web site, but as "The Tan Sheet" reported here, the agency quickly retracted it, saying it was wrongly posted.

But, here it is again.

In the Oct. 29 letter, FDA notes previous warning letters regarding combination products, including the October 2008 warning to Bayer Healthcare regarding Bayer Aspirin with Heart Advantage (aspirin/phytosterols) and Bayer's Women's Low Dose Aspirin + Calcium tablets.

Happy Days Are Here Again For Glaxo Consumer

A year ago GlaxoSmithKline was dealing with relatively flat consumer health sales, dogged by the disappointing U.S. performance of weight-loss OTC alli (orlistat). As we noted then, CEO Andrew Witty was hopeful that market expansion -- such as launching toothpaste brand Sensodyne in China -- and making strategic acquisitions, would right the consumer ship.

Today Witty boasted the U.K. firm's third-quarter consumer segment growth of 8 percent outshone the overall market expansion of about 1.5 percent, driven by innovations, acquisitions and global expansion. According to the firm's release, the segment tallied sales of 1.2 billion U.K. pounds ($1.9 billion under Oct. 28 conversion rates) during the quarter.

In the midst of a company-wide cost-cutting initiative, GSK has "been moving money from more mature activities to" the consumer business and has "more consumer innovation in development than we've ever had," Witty said during the firm's earnings call.

Lead Traces In Children's Face Paints Give Consumer Group A Scare

Days before Halloween, the Campaign for Safe Cosmetics has released findings from product testing indicating that children's face paints on the market are tainted with lead and other heavy metals.

OTC And Nutritionals News Round Up

As the cold and flu season kicks into high gear, new posters around our office remind us to cover our mouths when we cough and to stay home if we have the flu. Their appearance coincides with several developments in the cough/cold arena, including:

Australia May Restrict Pediatric OTC Cough/Cold Drugs…
Obama Declares H1N1 Emergency…

Likewise, FDA enforcement is nothing to sneeze at and firms sometimes act fast to comply. Among them:

Smart Choices Program Freezes Operations…

Humpday OTC/Nutritional Chatter

It's Wednesday and a balmy 70 degrees in Washington. Here's what we'd be chatting about around the water cooler if we had one:

CHPA says Rx status is not the answer for meth precursors...

FDA denies P&G's citizen petition for OTC proton pump inhibitor class labeling...

Senate HELP committee weighs in on food safety...

JAMA critiques regulation of homeopathic products...

FDA's commissioner's office gets busy filling in reorganization chart...

CRN sets sail for sand, sun, supplement symposium...

FDA Goes "Public" With Commissioner's Office Appointments

A slew of appointees to FDA's Office of the Commissioner all share backgrounds in public health work through government jobs or advocacy groups, such as Public Citizen. The mark of Commissioner Margaret Hamburg and Principal Deputy Commissioner Josh Sharfstein, both former health commissioners of large cities, is readily apparent.

The OC roster additions, announced in an internal agency memo Oct. 16, puts a few new players in the foods area. Jessica Leighton, a senior advisor on nutrition and food safety, comes from Hamburg's old stomping ground, the New York City Department of Health, where Leighton was deputy commissioner of environmental health.

At FDA, Leighton will report to the deputy commissioner for foods, a role that appears as yet unfilled. In August, "The Tan Sheet" reported here on the reorganization of the commissioner's office, and on Hamburg's assertion that a nationwide search is underway to find a deputy commissioner for foods.

Jeffrey Farrar, former director of the California Department of Public Health's Food and Drug Branch, is FDA's new associate commissioner for food protection. Though the memo does not clearly define Farrar's responsibilities, his post sounds similar to the one vacated recently by David Acheson. "The Tan Sheet" spoke to Acheson for an exclusive interview following his departure as associate commissioner for foods.

Vicks Drug/Supplement Combo Elicits FDA Warning

Update: A spokeswoman says FDA posted the warning letter in error and has no further comment at this time. Should the agency re-post the warning, Over The Counter Today and "The Tan Sheet" will be ready for it.

FDA has sent a warning letter to Procter & Gamble regarding a pair of Vicks products that combine acetaminophen, dextromethorphan, an antihistamine/nasal decongestant and vitamin C. The products in question are DayQuil Plus Vitamin C and NyQuil Plus Vitamin C.

Curiously, FDA appears to have posted the letter on its warning letters page and subsequently removed it. Reuters reports that the agency takes issue with P&G listing vitamin C as a dietary ingredient in the "Supplement Facts" box and as an inactive ingredient. According to the Reuters story, the agency fears this double-listing could confuse consumers. 

P&G issued a statement saying, "The addition of moderate levels of a vitamin supplement such as Vitamin C provides a new benefit for consumers who want it."

FDA's Enforcement Initiative: What Should You Do Differently?

In the spirit of shameless promotion, we answer that question: Purchase and listen to our webinar of that very title, coming up on Thursday, Oct. 22. Avoid extinction by learning how to stay in compliance and out of trouble with experts from Parexel Consulting.

Early bird pricing ends after Oct. 15. Get all the info and register HERE.

A New World (Of OTCs, Supplements And Cosmetics)

 

Or a new week, at least. Here's what we're talking about in the office today as everyone else wraps up their three-day weekend...

Airborne maker acquired by private equity firm...

Wealthy Americans rank skin care, makeup "best of the best" in online survey...

EBI's Silverman returns to Pharmalot...

Dueling With DSHEA Options

An American Herbal Products Association letter and a Harvard medical professor's op-ed piece represent the opposing views in the escalating battle over whether dietary supplements are regulated adequately in the U.S.

In an Oct. 7 letter to FDA, AHPA suggests FDA's approach to identifying and informing the public about bogus 2009 H1N1 products (compiled here) could help stop firms from marketing steroid-containing supplements.

FDA should model a hidden steroid initiative on the H1N1 initiative with a three-part program: searching the Internet for products labeled as containing synthetic steroid ingredients; sending warning letters to companies marketing those products; and "prominently" placing on FDA’s Web site a page with lists of products the agency has identified as containing synthetic steroids and that have been the subject of warning letters, according to AHPA President Michael McGuffin's letter.

Meanwhile, physician Pieter A. Cohen, of Harvard Medical School and the Cambridge Health Alliance in Somerville, Mass., adds his opinion to the growing criticism of the effectiveness of the Dietary Supplement Health and Education Act. In a same-day New England Journal of Medicine online article, Cohen says most doctors and consumers do not understand that vitamins and supplements available in the U.S. do not require pre-market regulatory approval.

"Lenient regulatory oversight" of supplements, he says, "combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity."