Mainstream press coverage of the dietary supplement and healthy food and beverage markets has been anything but positive this week, and the growing barrage of negative news could be a sign of things to come for the U.S. nutrition industry—particularly if the U.S. Food and Drug Administration (FDA) continues to make headlines with what appears to be a stricter regulatory enforcement stance under the new Obama Administration.
On May 13, ABC World News with Charles Gibson included a report about FDA’s warning to General Mills regarding the cholesterol-lowering claims the company is making for its popular Cheerios cereal. This news broke the day before and triggered many print and blog stories, but I was surprised to see ABC News give it more than a minute of prime-time news coverage and include in the piece a broader message that a growing number of food manufacturers are duping Americans with the misleading health claims they put on their products.
Dietary supplements have fared no better this week. On May 12, David Epstein wrote a scathing piece on SI.com (the Sports Illustrated Website) about the adverse health events consumers reported to the FDA in 2008 about dietary supplements. The examples listed in the SI.com piece mostly discuss fringe offerings from small companies and include products with names such as Nuclear Garbage and Fireball Liquifusion. However, Epstein did address more popular, mainstream products in his piece: "Many of the reports concern extremely popular products, like Bayer's One-A-Day Weight Smart Advanced, which lists increased heart rate—one of the common complaints—in its product information, according to the reports," Epstein wrote. "The most popular brands and products tend to have the most reports: Herbalife, VPX, BSN, GNC, 5-Hour Energy—and there are 14 reports about Hydroxycut, which was recalled by MuscleTech earlier this month after the FDA warned consumers that it could cause liver damage and had contributed to the death of a teenager in 2007."
By all accounts, the serious adverse event reporting (SAER) system, which went into effect in December 2007, is good for the supplement industry because it is actually helping to demonstrate the safety profile of dietary supplements. “Data shows the SAER system is functioning as a signal generator and demonstrating the safety of our class of goods,” American Herbal Products Association President Michael McGuffin told attendees of the SupplySide East Trade Show and Convention last month. “The dietary supplement industry fought hard for this good law, and AHPA is encouraged to see it working so well in its first six months.” According to AHPA, the number of supplement AERS submitted between Jan. 1, 2008 and June 30, 2008, were small compared to drug AERs—but you wouldn’t have known that from the SI.com piece.
Epstein’s story—which focuses on several products that in name alone do not appear to be helping boost the credibility of the supplements industry (Who names a supplement product Nuclear Garbage?)—did not come at a good time for the dietary supplement industry, which was already feeling the heat after Iovate Sciences’ recall of its popular Hydroxycut products earlier this month. The SI.com piece also emphasizes the damage a few allegedly bad products can inflict on the entire industry, especially in the age of the Internet.
One lesson I’m taking away from the news coverage the industry has garnered this week is that weeding out potentially dangerous products and pushing all companies to take regulatory compliance seriously are only going to grow in importance under today’s FDA, which certainly showed its muscle with the Cheerios warning. As Bruce Silverglade, legal director of the Washington-based Center for Science in the Public Interest, told Ad Age regarding the General Mills warning: “[FDA is] signaling the rest of the industry that the agency is not going to let a big market leader get away with [false or misleading claims] and won't let anybody else get away, either.”