Politicians Make New Attempt to Ban Supplements

Politicians Make New Attempt to Ban Supplements by Dr. Joseph Mercola

STORY AT-A-GLANCE

• Proposed legislation is calling for a federal database for dietary supplements, which requires supplement makers to submit information to the FDA
• Known as mandatory product listing (MPL) for dietary supplements, supporters claim it’s a way for the FDA to know what products are on the market and what ingredients they include
• Opponents suggest the move, which is redundant and burdensome for small supplement companies, could ultimately give the FDA more power to ban supplements from the market
• MPL could pave the way for the FDA to gain premarket approval power — changing access to supplements as we know it
• Multinational companies like Bayer, Nestle, Unilever, Proctor & Gamble and Clorox have also been buying up supplement companies at a frenzied pace. In 2018, there were 83 such transactions; this rose to 137 in 2021

The U.S. supplement market was valued at $48.4 billion in 2021, with an expected compounded annual growth rate of 8.9%.¹ In the U.S., where 80% of Americans use dietary supplements, the industry is viewed as trustworthy by the majority of adults (79%).² However, access to high-quality supplements is continually being threatened by legislation, along with corporate mergers and acquisitions.

Proposed legislation is calling for a federal database for dietary supplements, which could pave the way for the U.S. Food and Drug Administration (FDA) to gain premarket approval power — changing access to supplements as we know it.

Mandatory Product Listing for Supplements May Be Coming

In April 2022, Sens. Dick Durbin, D-Ill., and Mike Braun, R-Ind., introduced the Dietary Supplement Listing Act of 2022.³ The Act would require supplement makers to provide information about their products to the FDA, including (but not limited to):⁴

• A list of all ingredients
• An electronic copy of the label
• Allergen statements
• Health and structure/function claims

Known as mandatory product listing (MPL) for dietary supplements, supporters claim it’s a way for the FDA to know what products are on the market and what ingredients they include. But opponents suggest the move, which is burdensome for small supplement companies, could ultimately give the FDA more power to ban supplements from the market. According to Natural Products Insider:⁵

“Pete Evich, vice president of the lobbying firm Van Scoyoc Associates in the nation’s capital, cited ‘immense pressure’ from MPL proponents to get the proposal into an omnibus bill … Durbin is expected to lobby aggressively for MPL during the lame-duck session.”

Why the Push for Mandatory Product Listing?

The information that MPL would require is already available via existing sources, including facility registrations and product labels, which include ingredients and dosing information readily available for the public to see. The National Institutes of Health Dietary Supplement Label Database also contains some supplement label information.

Michael McGuffin, president of the American Herbal Products Association (AHPA), told Nutritional Outlook, “We keep … wonder[ing] why the reporting requirement is so redundant. It requires submission of not just the label but also a whole bunch of information that’s already on the label … You gotta ask this question: Should American taxpayers pay for two databases?”⁶

Meanwhile, a prominent concern is that along with being unnecessary and burdensome, MPL could turn into a tool for premarket approval, which the FDA could use to keep dietary supplements off the market. Daniel Fabricant, president and CEO of the Natural Products Association (NPA), explained to Nutritional Outlook:⁷

“The thing is, if the safeguards were there” — meaning language built into the bill to clearly state that the law doesn’t let FDA reject any database submissions — “they would be specifically spelled out. They would say, ‘Hey, nothing in this act would allow the Secretary to remove an ingredient that isn’t the subject of final agency action.’

… That would give you a safe harbor, but we haven’t seen any language here that would present that [in the current bills]. And, again, if the goal is … to get FDA labels? OK, those would meet that goal.

Now, if the goal is something else, well then people need to be honest about what that goal is. If that goal is to get FDA an administrative tool that’s in effect premarket approval? Yeah, that’s not going to work at all. Everyone is opposed to that.”

There’s also the possibility that MPL would bring the U.S. closer to adopting universal limits on supplement dosages and formulas — a move that would also restrict consumer’s access to therapeutic levels of such products. According to Alliance for Natural Health USA:⁸

“As we’ve seen in issues like GMO-labeling, where some states required labeling of GMO foods and others didn’t until federal law pre-empted state labeling laws, big companies don’t like dealing with a patchwork of regulations.

Mega-corporations doing business across the world would likely welcome harmonized levels of supplements so they can sell their products on the world market without having to change formulations or labels.

Higher-end products would be eliminated because they wouldn’t meet the ‘harmonized’ nutrient levels, and all that would be left are the most basic, cookie-cutter products that don’t support patient needs but make the most money — think of the supplements you see at CVS, or Walgreen’s, etc.”

‘We Need To Be Aware of FDA’s History’

Given FDA’s history of attacking dietary supplements, MPL needs to be viewed with extreme caution, particularly with regard to what it could morph into in the years to come via “regulatory drift.”⁹

Supporters have claimed an MPL database would help protect consumers by keeping fraudulent or adulterated products off the market, but even this is misleading, since criminals could easily submit fraudulent labels. AHPA’s McGuffin explained:¹⁰

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