The Natural Products Association (NPA) this week filed a “friend of the court” or amicus brief with the U.S. Supreme Court and the U.S. Attorney’s Office for the District of New Jersey that challenges legal action by the Federal Trade Commission (FTC) and Department of Justice (DOJ) against Bayer for its marketing of its Phillips’ Colon Health product.
The government filed an order on Sept. 12 in the U.S. District Court for the District of New Jersey, claiming the company violated an earlier 2007 consent agreement surrounding the claim that its One-A-Day WeightSmart supplement would increase metabolism.
NPA is concerned by this action for several reasons. The current Phillips’ Colon Health product under scrutiny makes the claim to defend against occasional constipation, diarrhea, and gas and bloating. These types of claims are sufficiently qualified and limited in scope to declaim any implied disease origins as structure/function claims permitted under the Jan. 6, 2000 Structure/Function Final Rule, which was written exclusively for dietary supplements.
While these are structure/function claims, the government contends that Bayer needs randomized, controlled, clinical trial (RCT) studies for the product for every strain. The sole support for this unprecedented argument is the report of the government’s expert Dr. Loren Laine, a gastroenterologist, who contends that such RCTs—and only such RCTs—are “competent and reliable scientific evidence.” While “competent and reliable scientific evidence” is the standard in FTC’s guidance and the government’s pre-existing consent decree with Bayer, substantiation can be demonstrated through clinical evidence other than RCTs. There is no legal basis at present for the government to require one or multiple RCTs as the only accepted form of evidence for claim substantiation.
If the government was correct in its assertion that such RCTs should be required in all cases, entire shelves at drug stores would become bare. According to the association’s brief, if the government’s filing based on the consent agreement from 2007 is allowed to stand, the distinction between dietary supplements and drugs will effectively evaporate. Dietary supplement makers will be forced to conduct the same rigorous clinical tests that are required for drugs, and, as a result, consumer choice, protected under the Dietary Supplement Health and Education Act (DSHEA), will be curtailed. Imposing full-scale clinical trials to substantiate structure/function nutritional statement claims is neither required by—nor even consistent with—DSHEA and prior regulatory guidance and judicial decisions.
Key arguments presented by the association in support of its position include:
- The government’s motion argues that Bayer’s structure/function claims must be substantiated by two randomized, controlled and double blind clinical studies. Dietary supplements that are not marketed as drugs were not intended to be subject to the same standards as drugs, which do require substantiation by full clinical trial research.
- No one who sells dietary supplements could rely on prior FTC and Food and Drug Administration (FDA) guidance, stating that RCTs are not required.
- The FTC and DOJ are trying to blur the lines between structure/function and disease claims through the back door of a consent decree rather than through public rule making outlined in the Administrative Procedure Act (APA).
- The Structure/Function Final Rule of Jan. 6, 2000 would be pre-empted by this decision. Structure/function claims would vanish, and all claims would be regulated as disease claims, which the government concedes Bayer did not make here.
- This novel, erroneous, ad hoc and unprecedented legal standard conflicts with DSHEA and all agency guidance issued for structure/function claims; imparts confusion to the industry; and threatens free speech.
“NPA is very concerned that the government is using consent orders to effectively re-write federal law on dietary supplements,” said Daniel Fabricant, Ph.D., NPA executive director and CEO. “It’s important to point out that consent orders, which are meant to be case specific, may have unintended consequences for consumers if applied across the industry. Those include not just increased costs, but also the possibility of the reduced quality and quantity of information about products available to consumers. We urge the court to carefully consider this case and recognize that the outcome could result in major consequences for consumers, retailers and manufacturers of dietary supplements.”