Back to the future for the Food and Drug Administration (FDA) regulating dietary supplements like prescription drugs. On April 12, 2004, the FDA issued a ban on the sale of all supplements containing ephedrine alkaloid ingredients, not just supplements with pure ephedra as an ingredient. In issuing its regulation, the FDA took the position that its action applied to an entire class of dietary supplements and it articulated the legal standard by which it could prevent or remove dietary supplements from the market. The ban did not include traditional Chinese herbal remedies or to products like herbal teas or even over-the-counter drugs. When issuing the ban, FDA Commissioner Mark McClellan said the agency spent six months building a legal and scientific basis under DSHEA guidelines that would withstand expected court challenges from supplement manufacturers. The agency also claimed that it had received approximately 16,000 ephedra-related adverse event reports.
Two dietary supplements companies, in Utah, filed suit in federal district court to block the ephedrine alkaloid ban. The ban was successfully challenged and overturned in 2005. In 2006, however, a federal circuit appeals court reversed the district-court decision. The companies then petitioned the U.S. Supreme Court to reverse last year's 10th Circuit Court of Appeals’ decision allowing the ban to stand.
On April 6, 2007, the Natural Products Association (NPA - formerly known as the National Nutritional Foods Association) joined the two companies in filing an Amicus Curiae (“friend of the court”) brief with the Court, asking it to reverse last year's circuit appeals court decision.
Unfortunately, the U.S. Supreme Court has just recently denied the Plaintiffs/Appellants’ Writ of Certiorari, which means that the 10th Circuit Court of Appeals’ decision (reversing the original lower-court decision against the FDA ban) to stand.
Can the FDA Regulate Supplements As Drugs?
The key issues in dispute are as follows:
(1) In banning ephedrine alkaloids in dietary supplements, did the FDA re-write the 1994 DSHEA law, without Congressional authority?
(2) In determining that this class of dietary supplements posed an "unreasonable" risk to the public, was the FDA's use of a "risk-benefit" analysis as the legal standard for supplement safety authorized by DSHEA?
(3) If the appellate-court decision stands, and the FDA's own ruling stands, in the future, will the same standards that govern the FDA's approval of drugs also apply to other classes or types of products, in this case dietary supplements?
Why this Case is Important
Throughout the Congressional and FDA regulatory history on the implementation of DSHEA, there has been the "foods are not drugs" issue. The Congressional intent behind DSHEA was to prevent the FDA from regulating supplements in the same manner as drugs. If the federal appeals-court ruling is allowed to stand, the distinction between dietary supplements and drugs will, in my view, effectively evaporate. This will not happen overnight. But, dietary supplement makers, of all shapes and sizes, will be forced to conduct the same “rigorous clinical tests” that are currently required for drugs, even though there currently are no Congressionally authorized similar standards applying to foods and supplements.
Some in the health-freedom community may try to twist this into a debate about one product line, that is, supplements containing ephedrine-alkaloid ingredients. For years, including the recent issue with the FDA's Guidance on CAM practices and products, health-freedom advocates have been concerned, to say the least, about the FDA getting the "camel's nose into the tent" in the foods-are-not-drugs issue. This legal case is just such an instance.
Some in the health-freedom community may want to dismiss the importance of this case based upon the participation of Natural Products Association (NPA), the trade group for the large dietary supplement companies. The NPA is the trade association that represents over 10,000 manufacturers, wholesalers, distributors, and retailers of natural products, including dietary supplements.
However, the scope of the case covers all shapes and sizes of supplement companies. Since the Supreme Court has now allowed the lower federal-court decision to stand, the FDA pre-market approval process for supplements will become extremely costly, forcing companies to raise prices on new products. The issue of "grandfathering"/exempting previous on-market supplements from undergoing the "risk-based" standard is yet to be determined. However, it appears that this would also be the case.
There are many issues of difference between these two segments of the dietary supplement community – for example, Codex. However, sometimes, threatening issues makes strange bedfellows.
What Can Be Done Proactively?
Since the Supreme Court has allowed the 10th Circuit Court of Appeals decision to stand, then dietary-supplement companies, their customers, and health-freedom advocates must now petition Congress for redress. That is our only true option now.