by Steve Mister
Much is made in our judicial system of the burden of proof—who has it and what the weight of that burden is. In criminal cases, the State has the burden of proof: “innocent until proven guilty.” In libel cases, the celebrity defendant must prove actual malice by the media outlet that defamed him. In contract cases, the plaintiff must prove a contract was breached, but the standard is only a preponderance of the evidence. In other words, a 51-percent likelihood that the defendant did as alleged.
The same legal concept is at the heart of dietary supplement law: who has the burden of proof to demonstrate safety, and how much evidence is enough to satisfy that safety standard? When the Dietary Supplement Health & Education Act (DSHEA) was enacted in 1994, it provided a clear division of responsibility. DSHEA would provide a certain assurance of safety for consumers of dietary supplements, but it was not intended to provide 100-percent certainty of safety. Not even pharmaceuticals that have undergone years of clinical investigation and FDA approval can assure that. (Drug recalls, anyone?) DSHEA purposefully sought to balance consumer access to products with a relative degree of safety. As then-Deputy FDA Commissioner Dr. Joshua Sharfstein pointed out at the Council for Responsible Nutrition’s (CRN) conference in late 2010, there is an inherent tension between access and safety. He acknowledged that, for the most part, DSHEA seemed to get that balance just right.
For products that were already on the market prior to 1994, the presumption of safety stayed with manufacturers. That’s not to say FDA couldn’t remove one of those ingredients from the marketplace; but, to do so, the burden would be on the agency. And if FDA could demonstrate a product carried “an unreasonable or significant risk of injury or illness,” it could remove that product from the market. FDA did just that with ephedra.
What about new dietary ingredients (NDIs) that would come to market after 1994? Under DSHEA, the burden of proof would lie with the manufacturer or distributor. Manufacturers would be required to submit evidence to FDA before the new ingredient entered the market. Failing to do so, or marketing a new ingredient in the face of FDA’s objection, was supposed to cause the product to be adulterated and subject to prosecution. At least, that was what DSHEA envisioned.
But what level of proof would be required? DSHEA answered that question, too, requiring that in an NDI notification, the submitter must demonstrate a reasonable expectation of safety in the new ingredient. In the early 1990s, the industry watched as FDA tried to restrict products such as black currant oil from being sold as supplements by holding them to the safety standard of a food additive—a “reasonable certainty” of safety—clearly a higher burden of proof on the manufacturer. The NDI standard was intended to create a new standard that still required some amount of safety data for review (with the burden on manufacturer, not FDA), but would allocate the burden of proof differently so as to lessen the requirements of proof, and adjust the balance between safety and consumer access. DSHEA was about ensuring consumers would have access to a wide variety of innovative nutrients and natural health products with a reasonable expectation of their safety.
