The American Herbal Products Association (AHPA) has been informed that Sens. Richard Blumenthal (D-CT) and Dick Durbin (D-IL) have introduced an amendment to the National Defense Authorization Act (S. 2943) to forbid sales of so-called “high risk” dietary supplements on military bases unless such product has been “verified by an independent third party for recognized public standards of identity, purity, strength, and composition, and adherence to related process standards.”
“It is illogical as a regulatory principle and unworkable from a business perspective to require one set of rules for products sold through one channel of trade, such as stores on military bases, and another set of rules in the rest of the country,” said AHPA president, Michael McGuffin. “AHPA opposes establishment of separate regulatory standards that are different in any particular from existing general standards, whether for dietary supplements or any other class of products, dependent solely on where the goods are sold.”
The amendment would require the Secretary of Defense, in consultation with the Food and Drug Administration (FDA), the Federal Trade Commission, and the Office of Dietary Supplements at NIH, to define dietary supplements that are considered to be “high risk” and would mandate that supplements marketed for muscle building, weight loss, and sexual enhancement be included.
In identifying these product categories the legislation appears to be alluding to classes of unlawful drugs that, in the words of FDA, “masquerade as dietary supplements.” FDA actively enforces against such products, often marketed as sexual enhancements or weight loss aids and, to a much lesser degree, as muscle building supplements, and the U.S. Department of Justice (DoJ) has brought numerous criminal actions against the individuals and companies that defraud the public with illegal products, identified in indictments as “misbranded drugs.”
“We share Senators Blumenthal’s and Durbin’s concerns about the risks presented by any falsely labeled product that contains an illegal and undeclared drug ingredient, and we support FDA’s and DoJ’s aggressive enforcement,” added McGuffin. “But a blanket requirement for third party certification is unwarranted for any dietary supplement products, and such a change to the law would unnecessarily burden companies selling legal products already compliant with the extensive dietary supplement good manufacturing regulations enforced by FDA. Even if limited just to so-called ‘high risk’ products, this requirement would have no impact on the rogue players operating outside of the supplement industry selling falsely labeled misbranded drugs, but it would limit choice for our military personnel and their families to obtain the wide range of lawful supplements in these categories.”
AHPA recently partnered with the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and United Natural Products Alliance (UNPA) to send a letter to senators urging them to oppose a previous iteration of this amendment.
The Senate has adjourned for the Memorial Day recess and returns to business on June 6, when it will resume debate and consider amendments to the National Defense Authorization Act. To date, more than one hundred amendments have been filed to the bill. It is unknown at this time, if or when the full Senate will vote on the Blumenthal/Durbin amendment.