News Alert: Mandatory Product Listing and Dietary Supplements


You’re probably distracted by the headlines about Ukraine, the Supreme Court, and Johnny Depp and Amber Heard. But if you care about dietary supplements, including sports nutrition products, you need to know what’s going on in a new bipartisan bill that has been introduced in the U.S. Senate. Dietary Supplement Listing Act 2022,one S.4090 will require dietary supplement marketers to list their products with the U.S. Food and Drug Administration (FDA), including an electronic copy of the label.

The sponsors of the act are responsible for the Mandatory Product Listing (“MPL”).He gives the FDA the information it needs to protect Americans from dangerous products that appear to be supplements, and cites tianeptine, an unapproved drug sold illegally as a dietary supplement, as an example of the problem. via MPL, The government would register every additional product on the market, at least in theory.

MPL sparked a fierce debate among industry trade associations.2nd Some industry groups applaud the bill3 and the “transparency” it provides,4 Arguing that the FDA will not “approve” or “reject” the product – instead, a public notice will be posted to regulators, retailers and consumers after the FDA accepts the label.5

The bill says that although marketers of existing products have a grace period to submit product listing submissions, eventually all products must be listed and new products introduced. former product may be released. When the FDA receives a company’s listing submission, billing requires the agency to “approve” a “complete listing” and provide an identification number. The process raises important questions. Can the FDA refuse to approve a product? If so, can a marketer continue to launch the product? If it can’t, MPL effectively doesn’t mean pre-market approval—the kind of authority the FDA has over prescription drugs, but not specifically. immortality supposed to be on dietary supplements?

This is exactly what some industry groups are complaining about. The Natural Products Association (NPA) denounced the MPL bill and sent a six-page letter to congress sponsors citing all the reasons why the bill was a disaster.6 NPA President and CEO Dan Fabricant, Ph.D., argues that the bill requires information readily available from public sources and simply adds unnecessary complexity without improving public safety. NPA Senior Vice President for Scientific and Regulatory Affairs RD, Ph.D. Doug Kalman describes the bill as practically worthless: “The FDA has not been able to use its current regulatory authority to remove unsafe or counterfeit supplements from the market. This law does nothing to protect the consumer.” Dr. Fabricant and Kalman recently participated in this excellent deep dive into the problems of the MPL bill on PricePlow’s video podcast. https://blog.priceplow.com/podcast/npa-vs-dick-durbin-s4090

Even Harvard’s Pieter Cohen, MD, long-time supplement industry critic, whom you might assume to be a supporter of the bill, instead called it a “waste of taxpayer money” that would limit the FDA’s enforcement capabilities by diverting it, not expanding it. their resources.7

What is my view when looking specifically at the sports nutrition market? The overwhelming majority of the market consists of safe, compliant products manufactured by responsible companies. But the truth is, there is a certain population of fitness consumers who want hyped muscle building and fat-burning ingredients like SARMs, DMAA-related ingredients, and steroidal variations, whether they’re labeled “dietary supplements”, “research chemicals.” ” or something else. Demand creates supply, and marketers who choose to meet that demand are unlikely to submit their labels to the FDA. This means that even if the MPL is passed, the illegal products will still be there as they are now, except more “underground”. So what does the bill really accomplish in this regard?

The real solution does not require changing the laws. If the FDA wants to pull illegal products off the market, it must stop flocking and to force existing laws in a much more coherent and methodical way. Current written laws provide the FDA with all the tools needed to remove non-compliant products from the market. MPL will only expand the government’s power over legal supplements and place unnecessary burdens on law-abiding companies. What can you do as an additional consumer? You can voice your opposition to the MPL bill by signing an online petition here: http://www.votervoice.net/Shares/BzN7dAj1ACeAXA_Zj-Z7FAA

References:

one. https://www.congress.gov/bill/117th-congress/senate-bill/4090/text

2nd. https://www.nutraceuticalsworld.com/contents/view_online-exclusives/2022-04-26/mandatory-product-listing-legislation-for-dietary-supplements-introduced-in-senate/

3. https://www.naturalproductsinsider.com/regulatory/time-now-enact-mandatory-product-listing

4. https://www.crnusa.org/MPL; https://www.raps.org/news-and-articles/news-articles/2020/6/a-mandatory-dietary-supplement-registry-transparen

5. https://www.nutraceuticalsworld.com/contents/view_online-exclusives/2022-04-26/ignore-the-red-herrings-myths-facts-about-mandatory-product-listing

6. http://www.npanational.org/wp-content/uploads/2022/04/Letter-to-Durbin-and-Braun.pdf

7. https://www.naturalproductsinsider.com/regulatory/harvards-pieter-cohen-excoriates-dietary-supplement-bill





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