McLEAN, Va. The Council for Responsible Nutrition’s president and CEO Steve Mister supplied the “opposing view” to a USA Today opinion piece published online Thursday regarding a recent Consumer Reports attack on the dietary supplement industry.
At issue is the public misconception that dietary supplements are unregulated. “While many users believe that sale of unsafe or ineffective supplements must be illegal, it is not,” USA Today opined, citing the Consumer Reports report. “The public has little protection from useless, fraudulent, dangerous or even deadly products, thanks to special protection Congress gave the industry in 1994.”
“Truth is, the Food and Drug Administration already has ample authority to regulate this industry,” Mister countered. “What it needs to do is use it. Look how quickly [the FDA] removed a popular weight-loss product last year, and how aggressively it targeted false cures for H1N1 influenza. [The] FDA can seize adulterated supplements, detain questionable ingredients at the border, ban products that pose significant risks of injury or illness and use criminal sanctions of the Food Drug & Cosmetic Act to prosecute those who market unsafe supplements.”
Opinions of regulation aside, Consumer Reports outlined problems with a dozen considered-to-be-dangerous herbal supplements — none of which would make any mass retailer’s bestseller list. “The media circus surrounding the latest issue of Consumer Reports implicates the entire aisle of mainstream dietary supplements based on 12 ingredients that combined make up less than 1% of the marketplace,” Mister noted. “Yet given the attention, one would think these 12 herbs represent the mainstream dietary supplement aisle at your neighborhood pharmacy. They do not. If any of these 12 ingredients is truly unsafe, then [the] FDA should ban its use,” Mister added.
“Spokesmen for the self-described ‘responsible’ part of the industry claim that the limited powers given the [FDA] are adequate to protect the public,” USA Today wrote. “But the record says otherwise. It’s so hard for [the] FDA to ban a product, that only one such case has ever succeeded,” the opinion continued, referencing the ban on ephedra sales in 2004.
However, two of the “supplement-use horror stories” cited by USA Today to support its argument don’t involve supplements at all, but illegally marketed adulterated drugs. In one case, USA Today identified a student athlete who bought a performance supplement online purporting to be legal and later wound up in the hospital with liver failure due to the steroid included within the supplement. However, a product adulterated with an illegal steroid, by definition, is an adulterated drug product, regardless of how it is marketed.
In another case cited by USA Today, an Oklahoma woman bought a treatment for Lyme disease that turned her skin blue. Again, according to the Dietary Supplement Health and Education Act of 1994 that the USA Today opinion suggested protects industry, supplement manufacturers cannot legally make disease-state claims.
“People will always yearn for a magic elixir, which is why supplements, like drugs, shouldn’t be allowed on store shelves [until] they’ve been proven safe and effective,” the USA Today opinion piece concluded.
“Calls for premarket approval show a disregard for consumers who want access to a wide variety of supplement products,” Mister countered. “Consumers should talk to their doctors or other healthcare professionals about any of the supplements they use to maintain a healthy lifestyle. That’s good advice regardless of the law.”