Bolstering Supplement Regulations

In 2004, after years of efforts, the U.S. Food and Drug Administration (FDA) banned a popular herbal supplement ingredient called ephedra. The weight-loss product had caused over 150 deaths and 16,000 adverse health events over a decade. Yet, before the ban, Americans were spending $3 billion on ephedra products every year.

The FDA first issued a bulletin noting the potential dangers of ephedra products in 1994. So, why did it take another 10 years for the agency to ban the ingredient?

The reason lies in a 1994 law that scaled back the FDA’s power to regulate dietary supplements, and one lawyer argues that to avoid future tragedies like the ephedra crisis, Congress should take a hint from European law and strengthen the FDA’s ability to regulate dietary supplements.

Richard Nowak, an attorney in Chicago, argues that by strengthening the regulations on supplement manufacturers, Congress could protect Americans from unsafe dietary products without putting those manufacturers out of business.

For years, the FDA treated many dietary supplements like drugs, meaning supplement manufacturers had to demonstrate the safety of their products before the FDA would approve the products for sale. In 1994, however, Congress dropped that requirement when it enacted the Dietary Supplement Health and Education Act (DSHEA), a law that supplement manufacturers helped write and pass.

Under the DSHEA regulatory regime, supplement manufacturers hoping to use new ingredients must notify the FDA and provide evidence that the new ingredient can “reasonably be expected to be safe.” But manufacturers do not need to prove that a new ingredient is safe. Instead, the law puts the burden of proof on the FDA: the agency can remove a dietary product, such as ephedra, from the market only if it shows that the product “poses a significant and unreasonable health risk.”

The European Union (EU) took a more proactive approach to regulating supplements. In 2002, the EU adopted the Food Supplements Directive (FSD), a counterpart to the DSHEA. The FSD puts a much higher burden on supplement manufacturers than does the DSHEA. As Nowak explains, the EU regulatory scheme “contains a ‘positive list’ of vitamins and minerals permitted to be used in dietary supplements.” Manufacturers who want to use ingredients that are not on the list must first convince the EU’s regulatory body to add the ingredients to the list. The process of adding an ingredient can take years and cost companies the equivalent of hundreds of thousands of dollars.

Nowak argues that the EU’s approach protects consumers from harmful products better than the DSHEA does. He notes, though, that the FSD has its share of critics. Detractors argue that the FSD places too high an economic burden on manufacturers and reduces consumers’ access to dietary supplements.

With both consumer protection and the critiques of the FSD in mind, Nowak argues that the United States should amend the DSHEA to establish a middle-ground approach to regulating supplements—an approach that is more stringent than the DSHEA scheme, but with a lower burden on manufacturers than the burden imposed by the European model.

Nowak proposes a system that puts the burden of proof on supplement manufacturers by requiring them to show “substantial evidence” that a new product is safe. Nowak argues that this increased burden is necessary because the supplement industry is growing and developing new products at an increasing rate.

To protect manufacturers’ interests, Nowak suggests applying more lenient standards to existing supplements. Under his proposed system, the FDA would review the safety record of supplements introduced after the DSHEA was passed. If the agency were to find evidence of serious negative health consequences from a supplement, it would investigate further to determine whether the supplement is safe, and ban it if it is not safe.

Nowak’s scheme would give even more protection to ingredients introduced before the DSHEA was introduced. These ingredients would be added to a list of approved substances similar to the EU’s “positive list.” To add their ingredients to the list, manufacturers would only have to prove that the ingredients were in use prior to 1994.

Nowak argues that his proposed regulatory regime would draw a beneficial compromise between consumer protection and industry freedom. He notes that the scheme would not affect most supplements on the market.

In addition, Congress has good reasons to consider strengthening supplement regulations. In addition to the ephedra crisis, one study found that supplements send at least 23,000 Americans to the emergency room each year. This finding suggests supplements’ dangers may far outweigh their potential benefits, especially given that researchers have found little to no benefit from a variety of supplements.

But any attempt to increase regulation of the supplement industry, however practical, will face a steep uphill battle. The industry spends millions of dollars on lobbying each year, and it has powerful allies in Congress, including Senator Orrin Hatch (R-Utah), who introduced the DSHEA bill.

It is no surprise that supplement manufacturers spend so much on lobbying, given that they sell billions of dollars of the products each year. The industry will also likely continue to thrive, as more than half of Americans take dietary supplements each year.

The biggest question might still be whether those supplements are safe and effective.