Mandatory product listing (MPL) has been a priority for the Food and Drug Administration (FDA) for several years. MPL would require dietary supplement manufacturers to notify the FDA before bringing a product to market and to upload label information to a central database.
The issues dominated headlines—and divided the industry—in 2022, but legislative attempts led by Sen. Durbin ultimately failed to pass Congress.
However, an MPL has remained a high priority for the FDA, and the Agency recently included calls in its 2025 budget proposals for legislative changes to require all dietary supplements to be listed.
Dietary Supplement Listing Act
In letters to the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA), Sen. Durbin stated: “When the Dietary Supplement Health and Education Act (P.L. 103-417) became law in 1994, there were 4,000 products marketed as dietary supplements in the United States. Now, FDA estimates that there are more than 95,000 of these products on the market. But, the agency does not know the true number—let alone what ingredients are included in those products.
“The Dietary Supplement Listing Act would have given FDA much-needed insight into the market and improved its abilities to initiate enforcement action against the companies that market dangerous or illegal ingredients, such as tianeptine, in their supplement products,” Sen. Durbin wrote.
Much of the letter focuses on the antidepressant drug tianeptine, also known as “gas station heroine”. The ingredient has been in the headlines recently when it was implicated in the death of a 37-year-old Ohio man who reportedly purchased a tianeptine-containing product marketed as a dietary supplement from a gas station.
AHPA, CRN & CHPA respond
In response to Sen. Durbin’s letter, Michael McGuffin, President of AHPA, told us: "AHPA, alongside responsible industry, opposes the marketing and distribution of products containing tianeptine that unlawfully masquerade as dietary supplements. For several years, FDA has warned of the domestic presence of products containing this substance in such products. We urge the agency to promptly use its authority to remove such unlawful products from the market. AHPA looks forward to continuing our discussions with Senator Durbin and other lawmakers to address the agency’s lack of enforcement on this matter."
CRN issued a statement in which the association said it "shares the Senator’s grave concerns that tianeptine is being fraudulently marketed as a dietary supplement when it is an unsafe and illegal substance. CRN’s members, and all responsible supplement marketers, do not sell this ingredient and condemn the sale of it".
"CRN has not only been vocal about the risks associated with products containing tianeptine misrepresented as dietary supplements but has also shown steadfast support for enhancing FDA’s regulatory oversight through initiatives like a product listing registry for supplements," the statement read. "We offered our strong support for Senator Durbin’s previous bill seeking to make product listing a reality, and we look forward to working with him again if new legislation is introduced."
CRN’s Steve Mister authored an op-ed for NutraIngredients-USA earlier in the day outlining his association’s ongoing support for a mandatory product listing.
Scott Melville, CHPA President and CEO, also issued a statement, saying his organization "commends Senator Durbin for recognizing the need for a modernized regulatory structure for dietary supplements that will further protect public health. Recent reports about the presence of tianeptine in products fraudulently marketed by unscrupulous companies as dietary supplements underscore the need for key regulatory modernizations to protect public health.
"Priorities such as mandatory product listing, increasing inspection capacity and clarifying FDA’s authority to better facilitate enforcement against unlawfully marketed products would enhance the Agency's ability to identify and more quickly remove illegitimate products from the market."
“DSHEA turns 30 in October, and since 1994 when this law was originally enacted, industry has grown from $4 billion to more than $50 billion today. Without modernization, bad actors will continue to prey on the fact that regulations have not kept pace with growth. DSHEA should protect the 21st century consumer who has access to an ever-expanding dietary supplement marketplace, and CHPA looks forward to continuing to work with FDA and Congress on the shared goal of regulatory modernization,” Melville added.
NPA: More of the same
The Natural Products Association (NPA) remains the most vocal opponent to MPL within the industry. Despite not receiving a letter from Sen. Durbin, Daniel Fabricant, PhD, president and CEO at NPA, told NutraIngredients-USA that his association would be responding.
"Sen. Durbin’s letter to NPA, the oldest trade association for the natural products industry, must have gotten lost in the mail,” he said, before adding that Sen. Durbin’s calls for an MPL were just "more of the same" and noting that the majority of the letter focuses on tianeptine, an illegal ingredient.
"Tianeptine is not a dietary supplement and was never a dietary supplement," he said.
Blast from the past
Congressional supporters of dietary supplements have long called for stronger enforcement action against products marketed as supplements that are tainted with pharmaceutical ingredients. For example, a 2015 letter from Senators Orrin Hatch (R-UT) and Martin Heinrich (D-NM) outlined their "deep concern" about individuals and companies engaging in "blatant criminal activity by manufacturing and marketing products that masquerade as 'dietary supplements' but contain anabolic steroids, active pharmaceutical ingredients (APIs) or analogues of APIs".
"These illegal products constitute a serious public health risk," the Senators stated in a letter to then U.S. Attorney General Loretta Lynch. "Therefore, we strongly urge DOJ, in cooperation with the Food and Drug Administration (FDA), to prioritize the aggressive pursuit of individuals and companies that illegally manufacture and sell misbranded drug products falsely labelled as dietary supplements. Such an approach would both incapacitate current criminal endeavors and deter new criminality."
NPA’s Fabricant said that many such illegal products are not difficult to find. "This is not an FDA resource issue," he said. "This is a will-power issue."
