Archive for July, 2009

Power Drinks, Cheerios, the FDA, and Us

Monday, July 20th, 2009

In 2005 the Canadian Food Inspection Agency reported that 71% or 117 of 165 sports nutrition products on sale violated regulations regarding nutritional information or labeling requirements. The expected results were concerted attacks and complaints by industry on the agency’s scientific methods. Nestlé Canada, however, the maker of Powerbar®, who complied with regulations, spoke out in support of CFIA’s initiative, saying that it will “rid the marketplace of products with illegal ingredients and claims“.

Here in this country, the Dietary Supplement Act of 1994 has overridden FDA pre-marketing responsibility for the safety of food and drugs. No longer would the FDA even regulate advertising claims, which became the purview of the Federal Trade Commission (FTC). As long as these products did not claim to treat or prevent disease, manufacturers could claim their diet supplements in any food or drink, enhanced performance, “energized,” controlled appetite, accelerated fat loss, relieved pain, “detoxified,” in short use their imagination to make virtually any claim.  Thanks to the 1990 Nutrition labeling and Nutrition Act, and 1993 supplemental rules by the FDA, in response to a 1995 petition submitted by Quaker Oats, the FDA in 1997 authorized the first food-specific health claim related to coronary disease (CHD) risk reduction.

The FDA did finally go after Quaker Oats for claims that Cheerios reduced cholesterol, but Quaker Oats simply changed the TV and other promotion to claim that the cereal could “help reduce cholesterol.”  If you like Cheerios, though, you can convince yourself you’ll live longer.

Power Drinks and the Market

How about the enticing  $18 billion a year market for power drinks? It hardly compares with the $70 billion a year soft drink market. Makers like Coca Cola are upgrading to new and ever more intensely promoted voodoo health drinks, e.g. Coke with Diet Coke Plus®, Full Throttle®, Pepsico with Tava®, Nestlé and Coke with Envige®, and Anheuser Busch, makers of Low Calorie 180 Blue® with Açaí “which uses only the highest quality ingredients, including carbonated water, vitamins B6, B12, C , …A serving of açaí berries has 80% RDA of antioxidants and it is said to contain 33 times more antioxidants than red wine grape.”

Literally hundreds of sports and power beverages adorn the soft drink aisles of your favorite supermarket: Max Velocity, Rockstar®, Monster, Sobe No Fear®, Red Bull® among others, most with various vitamins, minerals, amino acids (taurine, carnitine, arginine,) caffeine, and ginseng or other herbals. Retail prices are steep with Monster at $1.99 for 16 oz., Max Velocity® at $1.49 for 8 oz, and Red Bull® at $1.99 for 8.3 oz.

It reminds me of the cost of upscale bottled water in the range of $3.00 or more per gallon. And we complain about the cost of gasoline! (Think how much money you throw out every week in a country where municipal tap water is almost invariably superior and safer than the bottled product.)

Stay tuned.

Zicam: Smelling Trouble

Wednesday, July 8th, 2009

Welcome to corporate America and non prescription drug marketing. Matrixx Initiatives, maker of over-the-counter-health care products is best-known for its Zicam Cold Remedy swabs, hit a speed bump June 16 when the FDA advised consumers to stop using two of its remedies. Trouble began over six years ago when Forensic Advisors, set up by a former U.S. Attorney and CPA, Tim Mulligan, published a report describing what he called aggressive accounting practices at the company resulting in investigations by the S.E.C.  Mulligan’s report also warned that Matrixx might not be able to supply the F.D.A. with adequate support for its claims that Zicam reduces severity of cold symptoms.

According to the New York Times, the report noted criticism in medical journals which supported his findings.A month after the report, ENT specialists at a meeting of the American Rhinologic Society presented several cases of smell loss after the use of zinc-laced nasal gels.As early as 2003 consumers began to file lawsuits against Matrixx. In the meantime Mr. Mulligan and Forensic Advisors were named in a defamation suits by Matrixx, eventually causing him to shut down his research operation after two years battling outrageous  legal assaults and threats by the company. Later, with the emergence of more cases and official recognition by the F.D.A. these legal tactics were unmasked as a false and misleading attempt to silence a vocal critic. Mulligan was cleared, but his public crusades against corporate criminality were halted. We can only hope he returns to the fray, despite the legal perils of being a public whistle blower. It is indeed a shame and a disgrace that it took the F.D.A .in  over 130 cases reported to them since 1999 to confirm that Zican could cause anosmia (loss of smell). In fact, Matrixx Initiatives, settled approximately 340 cases in January 2006 involving people who alleged anosmia following use of Zicam. The S.E.C. is still investigating the company for accounting irregularities.

Matrixx Initiatives previously took the position that Zicam was a homeopathic drug not subject to FDA regulation. Yet, after the FDA issued the warning letter June 16 stating the products no longer can be marketed without FDA approval, more questions have arisen about the approval of over-the-counter drugs, supposedly enjoying certain exemptions from the Food and Drug Act.

No one knows  how many users of the nasal gel or spray developed this often permanent condition, anosmia. If one assumes the usual 10% reporting rate, thousands could be affected.  Moreover, loss of taste-the appreciation of flavors is-modulated by the sense of smell. Multiple class action suits have been filed against the company.

In the meantime Matrixx shares have fallen 71% since the F.D.A. announcement. This is not a surprise considering that Zicam cold remedies generated $78 million of the company’s $112 million revenue last year. I wonder what will emerge from further studies of cold remedies, their effectiveness and potential dangers.