In unmistakable collusion with Big Pharma, the concerted effort by government regulators, including the U.S. Food and Drug Administration (FDA), to ban Ivermectin as a safe and effective treatment against COVID-19 has been nothing short of criminal. Likewise, the FDA's censorship of supplements that have, for over two years, safely and effectively treated COVID-19 is telling. Indeed, countless consumers have turned to dietary supplements to successfully boost their immune systems and protect their health during the pandemic, positively impacting the industry. In the past, Big Pharma and the FDA have tried to ban certain supplements by classifying them as new drugs. Presently, the new draft legislation would demand supplements to undergo the same approval process as pharmaceutical drugs, surely making many obsolete.
The draft legislation would amend the Dietary Supplement Education Act of 1994 (DSHEA) and mandate product listing regulations. When Congress passed DSHEA more than 26 years ago, the industry began to break into the mainstream with $4 billion in annual sales of some 4,000 product offerings. With an estimated 50,000 to 80,000 different nutritional supplements currently available, the global dietary supplement market is forecast to reach a market value of $185.1 billion in 2025. In 2021, it was estimated to be worth around $137 billion. The market has been growing since 2018 and is expected to continue to grow through 2028. The U.S. market alone rose an estimated 12 percent in 2020 to a record $52 billion.
The proposed Mandatory Product Listing (MPL) is an argument that has come up for several years as discussions persist about updating the DSHEA. Cara Welch, the FDA's new director of the Office of Dietary Supplements Program (ODSP), has advocated for making the change in the past. The MPL would mean manufacturers would be required to register a new product with the FDA before putting it on the market. On several public occasions, FDA officials have stated that not having a solid grasp of what supplements are on the market impedes its ability to effectively regulate the market.
As the FDA approves mRNA "vaccines" despite being aware of devastating adverse side effects, the new legislation, if passed, would require companies to provide the agency with information about their natural health products. These would include product names, a list of all ingredients, an electronic copy of the label, allergen statements, health, structure, and function claims, and much more. If and when accepted by the FDA, the information would be available to the public. Speaking of the Dietary Supplement Listing Act of 2022 (which is part of a broader bill), sponsor Dick Durbin (D-IL), U.S. Senate Majority Whip, said in a May 2022 press release:
"FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them. With tens of thousands of products on the market, this bipartisan legislation will ensure transparency in the dietary supplements that Americans take every day. I'm pleased that a modified version of our bill was included in the HELP Committee's draft user fee package and I look forward to working with my colleagues to get this done."
Part of the more extensive Food and Drug Administration Safety and Landmark Advancements Act (FDASLP), the proposed legislation surrounding dietary supplements has faced significant pushback from many industry stakeholders. They argue that the language related to nutritional supplements and the MPL would compromise trade secrets, demand data from companies beyond what is on the label, and give the FDA new powers equivalent to pre-market approval. With the FDA's allegiance to Big Pharma and its COVID track record, the concerns are undoubtedly understandable.
Considering the supplement industry's unease and worries over the Senate's ability to pass the FDASLP, on July 14, 2022, Sen. Richard Burr (R-NC), ranking member of the Senate Committee on Health, Education, and Pensions (HELP) and sponsor of the FDASLA removed the dietary supplement provisions from within the FDA User Fee bill. The revised legislation, titled "Food and Drug Administration Simple Reauthorization Act," excludes provisions that impose a mandatory product listing requirement on dietary supplements. In favor of the removal, Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), commented:
"Senator Burr is absolutely right that extraneous, unnecessary and costly dietary supplement provisions have no place in this legislation, and should be applauded for this principled stance. The dietary supplement provisions in the FDASLA would drive up the cost for consumers while preventing them from accessing certain products.
As the nation faces record double-digit inflation, Congress should not be making it more expensive for Americans to stay healthy. Additionally, Congress has never required the nutritional supplement industry to pay user fees, and supplements are not prescription drugs, generic drugs, medical devices, or biosimilars, so including dietary supplement provisions was not only controversial but unprecedented."
However, despite Burr's effort, Michael McGuffin, president of the American Herbal Products Association (AHPA), points out that there are now three Congressional FDA user fee reauthorization bills in play. Two of them do not contain MPL, and one does. Nonetheless, for now, McGuffin said the developments are seemingly positive for those advocating for a final measure that does not include MPL. Still, for Burr's bill to progress, it would have to go via the HELP Committee, which is controlled by Democratic Senator Patty Murray (D-WA), who already voted for the FDASLA.
Moreover, even in the event of a temporary victory thanks to Burr's action, Big Pharma, with support from the FDA, has tried for years to get nutritional supplements off the market. As previously mentioned and reiterated by Dr. Joseph Mercola, one of the most often used tactics has been to attempt to reclassify them as drugs. Mercola points out that usually, Big Pharma would target specific nutrients (like Vitamin B6 and NAC) that stood in their way of profits. But legislation such as the current pre-market proposal would authorize the drug industry to dominate the market in one fell swoop.
It should be clear by now that Big Pharma, with backing from the FDA, will stop at nothing. Their strategies to dominate and control the health of American citizens are far-reaching. Besides attempting to heavily regulate the natural health market, the multi-billion dollar industry has been, as explained by Mercola, "simply buying up supplement brands."
Screenshot / Dr. Neal Smoller
In all, just 14 mega corporations—many of them drug manufacturers—now own over 100 of the more popular nutritional supplement brands on the market. Importantly, this monopoly over the supplement industry gives drug companies massive regulatory influence—and also a means to potentially destroy independent supplement makers who can't compete financially. Stating that nutritional supplements are the safest food-related products available, Mercola remarked:
"This new proposed legislation would technically ban most supplements, as few supplement makers have the financial resources required to meet drug approval requirements. The only ones with pockets deep enough to do that would be the mega-corporations.
Putting vitamins and nutrients through the drug evaluation and approval process would automatically eliminate many supplements from the market and result in higher retail prices for whatever remains. It would also allow drug companies to rename basic nutrients, label them drugs, and jack up the price even further.
We cannot let this happen. Dietary supplements are FOOD, plain and simple. They should not be treated as drugs, which must undergo rigorous testing to evaluate effects and safety. Supplements have a long history of near-spotless safety and don't need drug-style testing."
With Big Pharma, and government agencies and time working against those taking charge of their health, there are ways to take action now to protect supplements from disappearing. Fabricant, asking for America's health and wellness advocates to continue to write or call their members of Congress, insisted that "the war is far from over." Immediate grassroots involvement right now is critical to defeating this dangerous and radical proposal. While phone calls are most effective, the Alliance for Natural Health has created a prewritten email that will automatically be sent to the U.S. President, senators, and representatives. Click HERE to access and take action.