Responding to a recent story in Sports Illustrated (SI), the Council for Responsible Nutrition (CRN), Washington, D.C., stated that the article mischaracterizes the supplement industry and suffers from a lack of understanding of current regulation.

The article, entitled “What You Don’t Know Might Kill You,” appeared in the May 18th issue of SI and claims “Would-be experts and untested products feed a $20 billion obsession with better performance across all levels of sports.”

Steve Mister, president and CEO of CRN, said this figure is simply overstated. “The entire dietary supplement industry has U.S. sales of approximately $24 billion, with vitamin sales alone representing approximately $10 billion of the total market,” he said. “But the sports nutrition supplements that are the focus of this article represent sales somewhere closer to $2.5 billion. While that smaller figure is not nearly as dramatic as the $20 billion figure which teases the story, it is important, from a factual standpoint, to point out that the estimate in the article for sports nutrition products includes not just dietary supplements, but a whole range of conventional food products and drinks that are marketed for weight loss as well.”

He went on to say that a majority of companies in the supplement industry engage in responsible marketing and other business practices.

“Further, the article is surprisingly one-sided and suffers from an unfortunate lack of understanding of the Dietary Supplement Health and Education Act (DSHEA)—both in terms of what the law did, and what it allows FDA to do,” Mr. Mister added. “The article inaccurately suggests that dietary supplements are exempted from the entry requirements and regulatory scrutiny that apply to all other FDA-regulated products, including food and drugs. That is simply not so. According to the article, DSHEA ‘razed virtually every barrier to entry into the marketplace.’ With that premise, the extreme examples the article describes appear to be a product of DSHEA, when in fact, they more likely result from FDA’s lack of enforcement of that law over the past 16 years.”

Many in opposition of DSHEA claim that the law took away FDA’s authority to oversee the supplement industry. But Mr. Mister says DSHEA gave the agency new enforcement tools, even if it hasn’t applied them.

“In actuality, FDA chose to sit on its collective hands, refusing to take advantage of the new tools it now had, even ignoring the simplest requirements from Congress to issue new GMPs specific to dietary supplements,” he added. “Whether due to a lack of resources, a lack of interest or a lack of political will, following the passage of DSHEA, FDA failed to enforce the regulations that DSHEA put on the books. It wasn’t until Dr. Mark McClellan became FDA Commissioner in 2002 that the Agency emerged from its fog of inertia concerning the dietary supplement industry and began to look at and use some of the additional authority provided to it by DSHEA.”

The industry and its watchdog have come a long way in the past five years, according to Mr. Mister. “The article’s description is not how we—and responsible companies in the industry—understand the laws and regulations at all. To begin with, because dietary supplements are regulated as a category of food, in every respect they get at least the same levels of scrutiny accorded to any kinds of food—from breakfast cereals to canned soup—and in many respects they get even more.”

“The article also insinuates that anabolic steroids and pro-hormone ingredients are lawfully marketed under the law and that enforcement to remove these products from the market is left to the Drug Enforcement Agency (DEA) to ‘keep up’ with the ever evolving list of new metabolites and analogs of these anabolic steroids. That’s simply not true. Under DSHEA, most of these substances are not even legal dietary ingredients (i.e., they cannot be legally included in dietary supplements, period).”

Mr. Mister claimed that readers are left with no way to distinguish between legitimate sports nutrition products and those without sufficient safety profiles and quality assurance.

He concluded his response by saying: “Whatever the law, the ‘burden’ for consumer safety should always rest between a combination of industry responsibility and regulatory body enforcement. The article leaves the reader with the misimpression that the industry is suffering from a weak legal framework to govern bad actors and outliers—and that simply is not true. Now that FDA has set its regulatory mind to enforcing the law, it has the ability under the law to weed out bad actors—those who are not abiding by regulations. FDA’s job is to protect the public, and we urge Congress to provide sufficient budgetary funds for the agency to do its job, rather than wasting time and tax-payers’ money with re-writing laws unnecessarily.”