USP uses the term “dietary supplements” in a proposed General Chapter on tainted products. The proposed chapter’s title is “Adulteration of dietary supplements with drugs and drug analogs.”
Products in question are not supplements
“AHPA has significant concerns that the title for (the proposed chapter), some of the text within the proposed chapter, and the intended placement of the proposed chapter within USP’s Dietary Supplement Chapters imply that products that contain undeclared drugs or drug analogs are dietary supplements. They are not. Any such product is, in fact, a misbranded drug,” the organization wrote in a commentary submitted to USP.
AHPA has been on the forefront of the push to get lawmakers, regulators and other stakeholders to call things by what it considers to be the right names. It’s a battle that has been waged for years by AHPA and others to try to convince the wider world that fringe players who lump in active pharmaceutical ingredients into products are not producing dietary supplements at all and should not be considered part of the industry. There have been some victories on this front; for instance, AHPA notes in its comments that federal regulators seem to have gotten the message.
For example, AHPA quotes Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance, as stating in 2011: “These products are masquerading as dietary supplements— they may look like dietary supplements but they are not legal dietary supplements.”
And AHPA said in April of this year, the Department of Justice in an action taken at the behest of FDA against a seller of products that allegedly contained the weight loss drug sibutramine said the defendant had “introduced into interstate commerce purportedly all-natural dietary supplements that were sold as weight loss products”.
Slow, steady progress
Tami Wahl, AHPA’s special regulatory counsel, said the situation is slowly getting better, as fewer and fewer industry observers are automatically considering the outliers to represent the norm of the industry.
“Progress has been made,” Wahl told NutraIngredients-USA. “There has be progress made with people on the Hill, federal officials and regulatory agencies. It will take a longer time for public perception to come around.” Wahl said she believes the widespread usage of the proper nomenclature is not just a way to escape the irritation of repeated prodding from AHPA and others. Rather, she believes it is a true shift in how the sector is perceived.
“I will say that it is a genuine shift. There is more of an acceptance that supplements are a regulated industry, and that these tainted products are misbranded drugs and are not supplements at all,” she said.
Suggested new titles
AHPA’s comments note that USP has been sensitive to the need for accurate nomenclature, and in fact has an entire General Chapter on the subject. In that light, the organization proposed the following suggested title revisions, and suggested similar revisions within the text of the chapter itself.
- “Adulteration of products falsely identified as ‘dietary supplements’ or conventional foods with undeclared misbranded drugs and drug analogs”
- “Methods for detection of undeclared misbranded drugs and drug analogs in products falsely identified as ‘dietary supplements’ or conventional foods”
- “Methods for detection of undeclared misbranded drugs and drug analogs in orally-consumed products.”