Making the Case for Dietary Supplements and Nutraceuticals
By Scott C. Tips, J.D.
© 2023 Scott C. Tips
Sadly, the editors of the Scientific American – long captured by the pharmaceutical industry and the medical cartel – have recently published an editorial calling for even greater regulation of nutraceuticals. This editorial displays their ignorance of both the safety record of nutraceuticals as well as their efficacy. It also fails to compare the safety record of “underregulated” nutraceuticals with that of regulated pharmaceuticals. By any measure, the regulated pharmaceutical industry churns out killer drugs, for which it has been fined millions, and even billions of dollars time after time, while the supplement industry, including nutraceuticals, has a pristine safety record by comparison.
Still, the Scientific American – which itself eleven years ago pointed out how drug-company money was undermining science – forgets the pharmaceutical industry’s corrupt and serial criminal career of death and mayhem despite being highly regulated. Instead, the editors call for the same failed and corrupt regime to be imposed upon the dietary-supplement industry, which includes nutraceuticals. Because, despite the editors’ focus upon “nutraceuticals,” the solutions called for by the Scientific American’s editorial team would adversely impact all high-quality supplements.
In particular, the magazine’s editorial board opines that supplements make wild, unsupported claims of safety and efficacy, which have not been evaluated by the U.S. Food and Drug Administration (FDA) and are therefore suspect. The editors further argue that “some items in this market could pose a threat to human health and safety, and Congress should empower the Food and Drug Administration to start treating these products (as well as vitamins and mineral supplements) more like drugs.” (emphasis added)
Their solution for this imaginary problem? Heap even more paperwork on an industry that is already night-and-day safer than the pharmaceutical industry with all of the regulations that it follows. In particular, the Scientific American editors unscientifically push for mandatory dietary-supplement product listing that “would require supplement makers to register their product with the FDA and list all its ingredients, along with an explanation of how the nutrients in the supplement relate to its health claims.”
The Same Old Song
Of course, this is the same old song we have heard for decades. “No supplement is safe unless it is regulated by the FDA exactly as drugs are,” the authoritarian Pharma naysayers cry. Like the highly regulated drug Vioxx (500,000 heart attacks). Or Baycol (100,000 deaths). Or – dare we even mention it? – COVID-19 vaccine deaths (for the year 2022 alone, and in the U.S. only: estimated human damages were 26.6 million injuries, 1.36 million disabilities, and 300,000 excess deaths with estimated economic costs totaling $147.8 billion).
The list of deadly prescription drugs is nearly endless, and they are the third leading cause of death after heart disease and cancer in the United States and Europe. And approximately one-half of those who died were actually taking their drugs according to their doctor’s exact directions. The patients did nothing wrong other than to put their faith and trust in a medical system that is as careless with their lives as First World War generals ceaselessly ordering troops over the top to charge into the face of deadly machine gun fire.
In publishing this editorial that directs the danger away from deadly drugs and onto safe nutraceuticals, the Scientific American has blood on its hands. Perhaps, charitably, we could say that the magazine is just careless. As F. Scott Fitzgerald analogously observed in his fine novel The Great Gatsby, “they were careless people … they smashed up things and creatures and then retreated back into their money or their vast carelessness or whatever it was that kept them together, and let other people clean up the mess they had made.” Maybe the Scientific American is just careless in its thought and words, but carelessness can also kill, and where health is concerned this is still unforgiveable.
Drugs Are Dangerous
Andrew Saul, Editor-in-Chief of theOrthomolecular Medicine News Service, and someone fastidiously committed to optimal health for many decades now, has pointed out that, even when properly prescribed and taken as directed, legal drugs kill some 106,000 Americans each and every year. At over 2,000 deaths each week (and some doctors estimate the toll to be much higher), that is quite a death rate. Yet, the FDA remains pathetically unaccountable as do the pharmaceutical companies under its purview.
The number of serious adverse drug events reported to the FDA between 1998 and 2005 more than doubled to 467,809, according to a report in the September 10th issue of the Archives of Internal Medicine. Thomas J. Moore and his colleagues (at the Institute for Safe Medication Practices, Plymouth Meeting, Pennsylvania) analyzed serious adverse drug events reported to the FDA and found in addition to the number of cases reported in the Adverse Event Reporting System (AERS), the number of fatal adverse drug events increased from 5,519 to 15,107 in the same time frame, which is a 2.7-fold increase. “The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion,” the researchers concluded. Drugs raise serious concerns indeed; and, clearly, supplements and drugs are not even in the same class. Nor should they ever be treated in the same way either.
Supplements Are Safe
As I have been writing and saying for years, dietary supplements are exceptionally safe. Statistically, a person is more likely to die from a bee sting or a lightning strike than he or she is from taking any dietary supplements.
Andrew Saul confirmed this viewpoint when he wrote earlier this year, as he has been doing for several consecutive years now, that, “The 39th annual report from the American Association of Poison Control Centers (APCC) shows zero deaths from vitamins. Confirming data is in Table 22B, pp. 1613-1615, at the very end of the lengthy report published in Clinical Toxicology. . . . Furthermore, there were no fatalities from mineral supplements. Two fatalities from “Iron and Iron Salts” were clearly stated as not being due to supplemental iron.”
Saul noted that at least two-thirds of the U.S. population takes daily nutritional supplements: “A Harris Poll indicated that for American adults, the number is 86%. But let’s just use the lower number. Should each of those people take only one single tablet daily, that still makes over 220,000,000 individual doses per day, for a total of well over 80 billion doses annually. Since many persons take far more than just one single vitamin tablet, actual consumption is considerably higher, and the safety of vitamin supplements is all the more remarkable.”
What About Supplements Needs Fixing?
As the late health researcher and writer Bill Sardi repeatedly asked of FDA’s constant attempts to foist more regulations upon supplements, “What are we trying to fix? What is actually broken?” There is nothing that needs fixing. Are we really improving the safety of supplements through complex and costly regulatory guidance? Supplements are already safer than water and aspirin, not even to mention heavily regulated drugs! More paperwork and more money spent will not make our supplements any safer than they already are. Dietary-supplement products are already subject to post-market inspection, GMP standards, and other regulations. In a free market, consumer demand is the strongest authenticator. In the end, the market and consumers win.
Let’s be honest. The real reason behind the FDA using its Senate bagman Dick Durbin to try to shove its mandatory dietary-supplement listing requirement down our throats has nothing to do with safety. Rather, it is intended to drive more supplements off the shelves, raise their prices beyond the reach of most Americans, and to bankrupt or drive out of business the smaller dietary-supplement companies, thus deterring innovation and paving the way for the large pharmaceutical industry’s use of many of the very same ingredients, with now-skewed molecular structures, to sell them as patented drugs at a premium.
The FDA would further accomplish this by making it a “prohibited act” to introduce into interstate commerce “any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under Section 201(ff).” This is the administrative excuse by which FDA bureaucrats could reject ingredients like CBD (cannabidiol) and NAC (N-acetyl-L-cysteine) from being marketed as dietary supplements, regardless of their long history of safe use.
“Safety” is simply the FDA’s tool to force the public to accept a drug-happy world of medicine. If the FDA were truly concerned about safety, then it would halt its enforcement actions against the dietary-supplement industry and focus its efforts instead upon the industry where the real deaths occur: the ultra-regulated pharmaceutical industry.
Make no mistake, the Senator Dick Durbin bill in 2022 that would have mandated the listing of all dietary supplements with the FDA – which the Scientific American so fervently supports – would have driven up dietary-supplement costs, destroyed jobs and companies, stifled innovation in the supplement industry, seriously harmed the health of many millions of Americans, and moved consumers yet further toward dangerous drugs and vaccines and away from safe supplements. But our paperwork would all be in order!
It is important to remember that while mandating supplement ingredient lists may seem like a light regulatory burden, it may well be “the straw that breaks the camel’s back” when it comes to small and medium-sized businesses that simply cannot afford yet another regulatory cost and burden, which often must include an FDA-specialist lawyer as a member of the team in order to stay in business. The big corporations can tell their bank of attorneys and consultants to handle this new burden and the cost of it will be lost and forgotten in the many millions of dollars that they make, but what about the family businesses and even medium-sized businesses that are already struggling to make ends meet? This is a very unnecessary, additional burden to them, and one they do not deserve.
Stopped by NPA
In 2022, this legislative nonsense was strongly opposed and stopped, fortunately, by the Natural Products Association (NPA) along with its other allies such as the National Health Federation (NHF). We were able to strip any such requirement from the FDA User Fee Reauthorization Act of 2022, which was the base bill.
NHF lobbyist Charles Frohman states that, “because mandatory listing could prevent the sale of established supplements important to Americans, experts like NPA President Daniel Fabricant, Ph.D., are characterizing this effort as ‘pre-market approval.’” Frohman and others continue to watch for the resurrection of the Scientific American’s dream as an add-on to some bill in this new Congress.
The Scientific American’s editorial casts a strong suspicion that demands an explanation. Did they do their research or was this just an Op-ed passed off as real science? Then, from where did they get their data? Where are the statistics? Are they simply coasting on the confidence of their name and reputation, which, frankly, is very questionable after this cheap editorial?
Always remember the mainstream medical orthodoxy’s endgame, which is to greatly reduce the efficacy, availability, and affordability of dietary supplements. All of the post-DSHEA laws, rules, and regulations for supplements proposed by them have these immoral goals of blocking access to safe supplements and instead pushing people towards ill health and toxic drugs, no matter how much they try to camouflage the endgame with public protestations about “saving the children” or “protecting our health.”
This fight we are in will continue no matter how many people bury their heads in the sand and wish it away. Wrong-headed politicians like Durbin and careless journals like the Scientific American will win unless you and I and everyone else who believes in health freedom dig our heels in and say “Enough! It’s time to stop killing men, women, and children and start healing them instead.”
 The Editors, “We Need to Better Regulate Nutraceuticals,” Scientific American, June 2023, at https://www.scientificamerican.com/article/we-need-to-better-regulate-nutraceuticals/.
 Charles Seife, “How Drug Company Money Is Undermining Science,” Scientific American, December 1, 2012, at https://www. scientificamerican.com/article/how-drug-company-money-undermining-science/.
 Interestingly, the FDA has already begun using artificial intelligence (AI) and will no doubt delegate this ingredients review process to AI. However, the review will be deficient if AI is not fed the specific corpus pertaining to the countless studies that formulators rely upon for justifying their novel products (and claims) in particular or novel combinations of nutraceuticals or supplements. This could very well prevent legitimate dietary-supplement products from coming to market unless their corpus entails this dataset and possibly lead to fines levied upon manufacturers as well. See, e.g., Patrizia Cavazzoni, “FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing,” FDA, May 10, 2023, at https://www.fda.gov/news-events/fda-voices/fda-releases-two-discussion-papers-spur-conversation-about-artificial-intelligence-and-machine.
 Douglas A. McIntyre, “The Ten Worst Drug Recalls In The History Of the FDA,” 24/7 Wall St, Dec 10, 2010, at https://247wallst.com/investing/2010/12/10/the-ten-worst-drug-recalls-in-the-history-of-the-fda/2/.
 Edward Dowd, “Estimated 2022 US Vaccine Damage Report,” Twitter, March 28, 2023, at https://twitter.com/DowdEdward/status/1640734879355682816.
 Peter Gotzsche, “Our prescription drugs kill us in large numbers,” Polish Archives of Internal Medicine, 2014, 124(11): 628-634, at https://pubmed.ncbi.nlm.nih.gov/25355584/.
 See Lucian Leape, “Error in Medicine,” Journal of the American Medical Association, 1994, 272(23): 1851-1857, at p. 1851; Lucian Leape, “Institute of Medicine Medical Error Figures Are Not Exaggerated,” JAMA, July 5, 2000, 284(1): 95-97, doi:10.1001/jama.284.1.95.
 Moore T, Cohen M, et al., “Serious adverse drug events reported to the Food and Drug Administration, 1998-2005,” Archives of Internal Medicine, Sept 10, 2007, 167(16): 1752-1759, doi: 10.1001/archinte.167.16.1752.
 Ibid. See also “Adverse Drug Events Reported To FDA Appear To Have Increased Markedly,” Science News, Sept 12, 2007, at https://www.sciencedaily.com/releases/2007/09/070910132853.htm.
 Gummin D, Mowry J, Beuhler M, et al., “2021 Annual Report of the National Poison Data System© (NPDS) from America’s Poison Centers: 39th Annual Report,” Clinical Toxicology, 60:12, 1381-1643, at https://doi.org/10.1080/15563650.2022.2132768.
 Ibid. at p. 1607.
 Andrew Saul, “Zero Deaths from Vitamins, Zero Deaths from Minerals,” Health Freedom News, Winter 2022, Vol. 40, No. 4, at p. 28.
 See, e.g., Senate Bill S.4348, the FDASLA Act of 2022, Congress.gov, at https://www.congress.gov/bill/117th-congress/senate-bill/4348/actions.