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On his blog, Mercola.com, Dr. Joseph Mercola raises the alarm over proposed new FDA reporting requirements for dietary supplements. The new requirements will be burdensome for smaller companies and could push them out of business. Mercola explains:
Another threat to dietary supplements that could also turn into a preapproval system is the FDA’s New Dietary Ingredient (NDI) Guidance.11 An NDI, under the FDA’s definition, is any “dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.” Manufacturers that want to market a dietary supplement containing an NDI must notify the FDA about the ingredients.
While large corporations will have no problem complying with FDA’s burdensome NDI requirements, many small supplement makers may be pushed out of the market as a result. Alliance for Natural Health USA noted:12
“Simply put, the FDA is trying to install a quasi pre-approval system for ‘new’ supplements — those introduced to the market after 1994. In its revised guidance document explaining how they intend to implement this provision of the law, the FDA has signaled its intention to treat many, many common supplements as ‘new’ and thus subject to the onerous NDI requirements before they can come to market.
Note that the law passed by Congress only calls for a premarket notification system for ‘new’ supplements, but the FDA has tried to usurp power to turn this into a premarket approval system like the one they have for drugs. An economic analysis estimated that, if implemented as is, the NDI guidance could lead to the elimination of over 41,000 products from store shelves.”
Is the FDA Intent on Turning Supplements Into ‘Drugs’?
The FDA recently concluded that beta-nicotinamide mononucleotide (NMN), an antiaging ingredient, cannot be marketed or sold in dietary supplements,13 because it was investigated as a pharmaceutical drug.14
The conclusion came in response to an NDI notification submitted for NMN. The takedown of NMN is a harbinger of things to come, according to Chris Masterjohn, who has a Ph.D. in nutritional sciences. He tweeted that the FDA’s ruling that NMN is “an article authorized for investigation as a new drug,” is a “backdoor into essentially banning all supplements that do anything useful.”15
The key narrative continues to be the FDA honing in on the most successful supplements and essentially turning them into pharmaceutical products. Masterjohn continued:16
“I am not a lawyer and I am not an expert on FDA regulations, but I believe the FDA’s interpretation … means that the following will happen: a) company A wants to make a health claim for a supplement. They have to fill out an IND [investigational new drug]. b) company B does not want to do that.
They want to sell their supplement and make no claims. However, company A filled out an IND. Now, FDA concludes company B’s supplement is a drug.
With this interpretation, what will happen is slowly but surely everything on the market will be chipped off from “dietary supplements” and stacked onto “drugs” because companies that want to do research studies to show health effects will have to fill out INDs.
Once they fill out an IND, according to FDA’s current interpretation, that thing has become a drug, can no longer be a supplement, and is no longer a nutrient or food. In short, the FDA is completely unhinged.”
Big Corporations Taking Over Supplement Companies
Meanwhile, multinational companies like Bayer, Nestle, Unilever, Proctor & Gamble and Clorox have been buying up supplement companies at a frenzied pace. In 2018, there were 83 such transactions. This rose to 137 in 2021.17 For instance, Nestle Health Science, a division of Nestle, now owns:18
Pure Encapsulations Douglas Foods Garden of Life Vital Proteins Nuun Wobenzym Persona Nutrition Genestra Orthica Minami AOV Klean Athlete Bountiful, which owns Solgar, Osteo Bi-Flex, Puritan’s Pride, Ester-C and Sundown “Several of these brands are higher quality supplement companies,” Alliance for Natural Health USA noted.
“What will happen to them now that they are owned by mega-corporations that have not historically had core natural health principles as the foundation of their businesses? We’ve spoken to several of the largest and highest quality brands that have not been purchased; they have confirmed that larger companies have made several unsuccessful attempts to purchase them.”19
Why are there continued attempts to make supplements drugs and for mega-corporations to acquire their makers? “Where there’s money to be made, big players will want to cash in,” Alliance for Natural Health explained.20 The end result for consumers could be disastrous, however, including restricted access to supplements and inferior products on the market:21
“Overall, this level of consolidation isn’t good for competition, because just a small number of companies can make decisions that affect our supplement access, and many of them do not share the values of small, independent companies who go into business to fill a need in the natural health sector.
Issues over quality of supplements and access to higher dosages become the decision of a smaller and smaller contingent of companies — this is not good from a health freedom standpoint.”
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