Amazon—the vast global internet enterprise that single-handedly shuttered countless smaller retailers—is putting the interests of big pharma ahead of the health and well-being of its customers. In a move that surely pleases the FDA and pharmaceutical companies, Amazon decided last month to no longer sell nicotinamide mononucleotide (NMN), a molecule naturally occurring in all life forms and vital in longevity. On the cutting edge of lifespan research, Amazon’s decision to remove NMN products is unrelated to safety issues. Instead, it hinges on a recent FDA decision announcing that because NMN is under investigation by big pharma as a potential new drug, it can no longer be marketed as a supplement. With the FDA’s corruption in full view thanks to COVID, this isn’t the first time the agency has allowed pharmaceutical giants to turn natural ingredients into profitable drugs while banning the affordable supplement version.
Like many health-related choices tainted by government bureaucracy, there is, of course, a somewhat convoluted and complicated backstory behind how this can happen. But to be brief, the FDA can remove a healthy natural product from store shelves because of the preclusion provision of Section 201 (ff) of the Federal Food, Drug, and Cosmetic Act. This provision states that before a company can market any “new dietary ingredient” (NDI)—which means any ingredients that weren’t sold “in or as a supplement” before 1994—it must first submit a notification to the FDA with studies proving its safety. The guidance appears relatively straightforward, but not when, as is the case with NMN, the FDA deliberately blurs the lines.
The FDA’s requirement becomes deeply problematic for supplement ingredients because if a pharmaceutical company files an investigational new drug application and researches that ingredient before the FDA receives an NDI notification, the ingredient can no longer be marketed as a supplement. But, according to authorities in the supplement industry, that’s not the case with NMN. Nonetheless, once the FDA authorized NMN to be investigated as a new drug in October and November 2022 (and denied NDIs for NMN’s use as a supplement), its days as an effective and popular natural health supplement were numbered, with Amazon leading the FDA’s charge. The FDA’s nefarious activity begs the question, which moved front and center with the experimental COVID-19 injections, did the agency consider the health of Americans in any aspect of its decisions?
Unfortunately, the agency’s action is not surprising considering the FDA’s lucrative covert relationship with Big Pharma. Still, it is alarming and underhanded. According to Steve Mister, CEO of the Council for Responsible Nutrition (CRN), before releasing its October and November letters giving NMN the greenlight to be investigated by drug companies, the FDA had acknowledged an NDI for NMN “without objection.” Mister also shared in a press release that “the FDA has not previously raised any concerns publicly about the ingredients being used in dietary supplements.” Alarmed at the FDA’s unprecedented—and deceptive—actions, Mister remarked:
“Much of the innovation for dietary supplements comes from the introduction of new ingredients. But FDA’s actions demonstrate a disregard for consumers who benefit from the innovation and investments of dietary supplement companies.
These decisions to broadly invoke drug preclusion to protect the profits and monopolies of drug companies do not serve a public safety objective. The FDA’s reasoning and its refusal to provide a date certain when the authorization as a drug occurred just further raise concerns that it is protecting pharma’s interests over consumer welfare.
The announcement this week on β-NMN just perpetuates the uncertainty around the drug preclusion issue and furthers FDA’s course of plucking individual ingredients out of the supplement marketplace without warning. Manufacturers, retailers, and consumers are left in limbo each time this happens.”
For those unaware, NMN is an extraordinarily-popular supplement. It is a precursor of the critical coenzyme nicotinamide adenine dinucleotide (NAD)—a molecule with a crucial role in numerous metabolic processes, including generating biological energy from glucose and oxygen, helping proteins regulate cellular functions, DNA repair, and mitochondrial maintenance. Also restricted by the FDA, NAD levels decrease with age because we produce less and use it up faster. This two-fold setback can lead to accelerated aging and increased risk of heart disease, Alzheimer’s, and type 2 diabetes. With abundant evidence for anti-aging and health-enhancing effects that aren’t tied to the profitable FDA-pharmaceutical industrial complex—and instead help maintain health and vitality naturally—it’s no shock the FDA would want to prohibit NMN’s use for anything other than a regulated money-making ingredient.
And that’s what the FDA and the U.S. Military are doing. Due to its success in alleviating age-related ailments in animals, namely rodents, pharmaceutical companies like Metro Biotech have begun clinical trials investigating NAD and NMN as a drug for humans. Specifically, using Other Transaction Authority (OTA) funding, the U.S. Military Special Operations Command (SOCOM) has partnered with Metro Biotech to produce an NMN-based pill that may inhibit or reduce some of the degenerative effects of aging and injury. In 2021, Lisa Sanders, director of science and technology for Special Operations Forces, acquisition, technology & logistics, spoke of the Pentagon’s push for “improved human performance” and the excitement around its pharmaceutical-grade NMN anti-aging pill called MIB-626, stating:
“[The pill] has the potential, if it is successful, to truly delay aging, truly prevent onset of injury—which is just amazingly game-changing.”
Dr. David Sinclair, an aging and longevity researcher at Harvard, co-founded Metro Biotech. For years, Sinclair has touted the benefits of NMN as part of a safe, affordable, and easily accessible anti-aging regimen. Yet, now, with the creation of Metro Biotech, Sinclair is the primary force driving the FDA to ban the supplement form of NMN. Once the word got out and his role became clear, many in the industry questioned Sinclair’s motives and seemingly greedy move.
On December 15, 2022, Sinclair issued a statement on Twitter distancing himself from Metro Biotech. He acknowledged that the FDA’s decision that NMN is not a legal supplement was preceded by a letter from Metro Biotech. However, he added that although he co-founded the company, he does not manage or control it. OK, sure, it seems logical that a medical professional who has promoted NMN for years and then forms a new drug company that partners with the Military to produce a profitable anti-aging pill based on NMN has nothing to do with asking the FDA to stop letting Americans buy it in supplement form. Sinclair’s vision for NMN, which will also line the FDA’s pockets, becomes glaringly apparent when he says in the same statement:
“The important work of bringing NMN to market as an FDA-approved medication is in the best interest of the tens of millions of people who suffer from and will succumb to aging-related diseases. The FDA standards for testing, quality control, and efficacy are among the most responsible consumer protection regulations in the world. All consumers deserve the trust, safety, and reliability that comes with appropriate regulation and oversight.”
The FDA has been after supplements for years, often implying they are unsafe, even though they must adhere to stringent regulations outlined in the Dietary Supplement Health & Education Act or DSHEA. Suspiciously, in the past, the FDA has deliberately refused to enforce laws around supplements, and it appears the agency’s tactics to govern them are becoming more brazen. Several experts in the dietary supplement industry, including Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association (NPA), share Mister’s frustration with the FDA’s bending of the rules where it sees fit. Fabricant, who asked the FDA to reconsider its ban on NMN and was rejected, shared his thoughts on the situation, remarking:
“This latest example of the FDA’s misinterpretation of the law is wreaking havoc on the marketplace and causing confusion and significant economic harm.
This [is] the first time in history that [the[ FDA reversed itself on an acknowledgment letter for a new dietary ingredient without a shred of evidence that safety was at risk. It is setting a new precedent in that an announcement of Generally Recognized as Safe no longer constitutes evidence of the marketing of NMN as a food before the ingredient was authorized for investigation as a new drug.”
For now, NMN will most likely remain on the market despite the FDA ban. According to Mister, when the FDA decides an ingredient no longer meets its definition as a dietary supplement, they issue a letter to companies that market it. But, he explained, “unless the FDA decides to then go out and exercise some enforcement, it does not require that the companies pull the ingredients.” In February, Fabricant called on Amazon to allow its e-commerce retailers to continue selling products containing NMN after the March 13, 2023, FDA deadline.
With NMN supplements still available on Amazon as of March 17, it is unclear how the situation will unfold, but with a new drug on the horizon, action to get it off the market seems likely. According to industry insiders, a silver lining to Amazon’s ban is that many low-grade imposter brands from overseas will be eliminated. Without a doubt, Amazon is saturated with cheap products made in China. And let’s not forget its online pharmacy and prescription delivery service. Amazon will surely reap more profits if NMN is a medication pushed by Big Pharma instead of a supplement its retailers sell. Still, Fabricant hopes to change Amazon’s mind. In a public plea to the “world’s biggest retailer,” Fabricant spoke further of the FDA’s abuse of power, hoping the shopping Goliath would take notice, stating:
“FDA’s growing and repeated abuse of the law is sending shock waves across the dietary supplement industry. If the FDA can change decisions overnight by repealing an acknowledgment letter without foundation, what’s to stop them again? If the agency can exclude NAC from the definition of a dietary supplement despite the science, what’s to stop them from doing it to a different ingredient? If the agency can lobby for unneeded new authorities like a mandatory product listing while ignoring a regulatory path for CBD, which is available on every street corner in America, who will stop them? This is inexcusable and downright shameful, and NPA will use every available resource to ensure the agency is again accountable to consumers and the industry.”
Unquestionably fitting, the bottom line, as established by The Project On Government Oversight (POGO):
“The FDA is addicted to drug money.”