It's not an unreasonable concern.  After all, reports of excessive dietary supplement regulation by the Food and Drug Administration (FDA) spurred the enactment of the Dietary Supplement Health and Education Act (DSHEA) back in 1994.  DSHEA, the brainchild of Senators Orrin Hatch [R-Utah] and Tom Harkin [D-Iowa], was enacted when members of Congress perceived that FDA was engaging in improper policy and enforcement efforts to deprive the public of safe and popular dietary supplement products.  Passed with the unanimous consent of Congress and signed into law by President Clinton, DSHEA represented a sharp slap at FDA's regulatory tactics of the time.  The law defined the basic terms that apply to dietary supplements and their ingredients, and it put up significant roadblocks to FDA overreaching.  

Throughout the Bush years, the regulatory agencies took a predominantly laissez faire or "hands off" approach to the supplement industry.  But times have changed.  With a Democrat in the White House and a Democratic Senate capable of passing legislation without the threat of a filibuster, the pendulum seems poised to swing toward a more active FDA.  After all, conventional wisdom holds that increased Democratic influence in the Executive or Legislative branches means increased regulation.  That can be good or bad, or even some of each.  Too little regulatory oversight is an invitation for abuse and corruption, as you can see from what's happened in the banking industry.  On the other hand, excessive meddling by Uncle Sam in the name of consumer protection suppresses individual choices and freedoms.  Sometimes, the limitations imposed on all Americans are based on the least responsible common denominator of conduct.

These days, FDA and other regulatory agencies are boldly stepping in, as evidenced by a high-publicity parade of reports about sports nutrition supplements being contaminated with undeclared pharmaceutical ingredients, causing failed sports doping tests, or being associated with claims of various illnesses.  

Not surprisingly, Margaret Hamburg, M.D., the newly appointed FDA Commissioner, directed a portion of her remarks at the sports supplement industry in outlining her agency's priorities during a recent speech.   Dr. Hamburg vowed to be more aggressive, responsive and timely in enforcing FDA's rules and regulations.  One of her key areas of focus: the sports nutrition market.  Dr. Hamburg said the tougher policies were based on public safety concerns, citing reports of "serious and life-threatening adverse events" associated with "over-the-counter body-building products."  She pointed out that FDA has posted a Public Health Advisory and other materials urging consumers to stop taking bodybuilding supplements that are labeled "as containing androgen-, estrogen-, and progestin-related active ingredients."  She voiced the position that such products are unproven and unapproved drugs, not dietary supplements, even calling them "anabolic steroids."  

There's room to argue as to what differentiates an "unapproved drug" from a "dietary supplement" in some cases.  However, substances that don't meet the requisite criteria to be sold as supplements are illegal to market.  And there's no denying that what's on the supplement label should be what's in the supplement bottle - nothing less, nothing more.  Similarly, if labels or claims are false or inaccurate, the long arm of the law should be expected to reach in and solve the problem.  And, of course, if prescription drugs turn up in a supplement product, the Government has an absolute duty to investigate and an obligation to protect American consumers.  

So, Dr. Hamburg's fundamental positions have merit.  However, her comments, combined with the recent enforcement efforts, confirm an extremely important point.  It's one that the supplement industry has made for many years, namely, that the existing law provides for ample regulation to police the market.  Contrary to mainstream media reports, DSHEA did not leave the federal government paralyzed.  The supplement industry is not unregulated.  It's regulated by the Center for Food Safety and Applied Nutrition (CFSAN), a branch of the FDA, along with the Office of Dietary Supplements (ODS).  The Federal Trade Commission (FTC) also has jurisdiction over the claims (marketing, from implied to direct claims) that manufacturers make about their products.  We don't need to amend DSHEA or to enact new laws to control the greed or recklessness of the few bad apples in the industry.  FDA just has to do its job, and it appears it will indeed do so aggressively under Dr. Hamburg.  

Rather than facing the future with fear and dread, sports supplement consumers should look ahead with confidence.  New controls over the supplement industry, such as mandatory reporting of serious adverse events and the phasing in of standard Good Manufacturing Practices will help improve safety and quality, better protecting consumers from dangerous or contaminated products.  

As for industry, reputable and trustworthy supplement companies that work hard to produce safe and effective products based on sound science should feel guardedly optimistic about the new direction.  Agencies that fairly and sensibly enforce the requirements set by DSHEA are nothing to fear.  Let's hope that under Dr. Hamburg's watch, FDA will apply good sense and sound discretion in its enforcement tactics, such as foregoing SWAT team raids when simpler and more cost-effective solutions are available.  In a regulatory environment in which the provisions of DSHEA are fairly and reasonably enforced, we can enjoy the optimal balance of consumer protection and individual freedom.



Rick Collins, JD, CSCS [www.rickcollins.com] is the lawyer that members of the bodybuilding community and nutritional supplement industry turn to when they need legal help or representation.  [© Rick Collins, 2009.  All rights reserved.  For informational purposes only, not to be construed as legal or medical advice.]

  The full text of the speech can be found at http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm.