Stop FDA Threat to Consumer-preferred Dietary Supplements

The 86% of Americans using dietary supplements will not be pleased to learn that Congress and the U.S. Food and Drug Administration (FDA) are colluding to threaten consumer access to cherished, natural health care – and during a declared Emergency when supplements rise in importance to save lives.[1] Will you please cosign Representative Duncan’s letter urging deletion of the “Dietary Supplement Listing Act” from the FDA User Fee Reauthorization bill (S. 4348)?

When considering government supplement regulation, it’s important to keep in context the overweening influence of Big Pharma – stemming from an FDA 1992 report concluding that supplements threaten pharmaceutical companies’ pursuit of patent monopolies.[2] To the chagrin of pharmaceutical special interests, Congress soon thereafter protected supplements from bankrupting drug-like approval requirements with the 1994 Dietary Supplement Health and Education Act (DSHEA).

DSHEA did set up a more elaborate regulatory structure for supplements, however. FDA requires registration by supplement manufacturers whose processes, products, new ingredients, and labeling can be inspected – and shut down – at any time.[3] FDA is helped by an Adverse Event reporting system that signals to it which manufacturers to inspect. In addition to FDA regulation of supplement labeling claims, the Federal Trade Commission monitors and even actively searches for any fraudulent claims in supplement marketing.[4]

One may wonder why we oppose mandatory product listing if such products already are subject to post-market inspection. The reason is the Dietary Supplement Listing Act makes 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).”[5] This is the administrative excuse FDA bureaucrats could use to reject ingredients like CBD (cannabidiol) and NAC (N-acetyl-L-cysteine) from being marketed as dietary supplements, regardless of the science or history involved.

NAC is a known COVID-19 treatment, raising the natural suspicion that mandatory listing is intended to protect pharma vaccine profits from a natural competing treatment. Not waiting for this new bill, the FDA has nearly bankrupted NAC manufacturers with Cease & Desist Letters against any claims to treat COVID-19.[6] Because mandatory listing could prevent the sale of established supplements important to Americans, experts like former FDA Supplement inspector Daniel Fabricant are characterizing this effort as “pre-market approval.”[7]

It is important to remember that while mandating supplement 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. The big corporations can tell their bank of attorneys and consultants to handle this and the cost of that burden will be lost in the many millions 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 they do not deserve it.

The Senate provisions also would compromise the security of the supply chain by requiring FDA to maintain a “publicly accessible” database of detailed information related to supplements, ingredients, and formulations.[8] Currently, this type of information is available to FDA but is shielded from public disclosure under the Bioterrorism Act to protect it from falling into the hands of malicious actors seeking to introduce contaminants into the nation’s food supply. The Senate bill would undermine these carefully crafted protections, as well as publicly reveal the confidential, proprietary formulations of supplement manufacturers, a sure disincentive to progress if there ever were one.

One might ask how we reached this impasse around supplement access. It started with a misleading 2015 U.S. Department of Health and Human Services study “showing” 20,000 hospitalizations blamed on supplements.[9] What the news coverage on this study ignored was 20% of injuries stemmed from unsupervised babies swallowing their parents’ supplements, and another 40% comprising elderly people getting supplement pills stuck in their throats. Other harms stemmed from heart palpitations with outlier supplements for energy, sexual performance, or weight loss. A certain percentage stemmed from illegal ingredients, which the FDA itself failed to stop (many say deliberately). The FDA already has the authority to remove adulterated products from the market.

Supplements are already the safest consumer products on the market. According to Andrew W. Saul, Editor-in-Chief of the Orthomolecular Medicine News Service, “The 38th annual report from the American Association of Poison Control Centers (AAPCC) shows zero deaths from vitamins. Supporting data is in Table 22B, pp. 1476-1478, at the very end of the report published in Clinical Toxicology.” He continues, “On page 1477 there is an allegation of a single death attributed to an unspecified, unknown ‘Miscellaneous Vitamin.’ The obvious uncertainty of such a listing diminishes any claim of validity.”

Saul’s point about supplement safety is well made, even if one uses the lowest figure of half of the American population consuming a single daily nutritional supplement tablet, which makes close to 170,000,000 individual doses per day, for a total of well over 60 billion doses annually. And “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.” Senator Durbin needs to focus on where the real problem is: the high number of deaths from drugs!

Because, ignored in the scare story was any context – including comparisons with drug injuries.[10] While natural supplements allegedly “injure” 20,000 in a year, drugs approved by the FDA injure almost 2 million. One over-the-counter drug, aspirin, harms annually 60,000 people – far more than all dietary ingredients COMBINED. And the purported supplement-injury figure does not fit with a similar study by the U.S. Government Accountability Office, which found a little over one thousand annual harms from 2008 to 2011 – or the CDC’s actual database for supplement adverse events, garnering barely over 3,000 in one year, 2012.

The proposed language in the FDA User Fee bill requires pre-market approval for dietary supplements, and thus is more stringent than the New Dietary Ingredient (NDI) provision which is supposed to be just a notification. Regarding the NDI guidance, we want to express our opposition to it if it reflects the 2016 FDA NDI redraft, which threatened to implement bankrupting safety and effectiveness studies to be required whenever an old supplement is recommended for a new population, when using new manufacturing innovations, or when proposing new doses.[11] The first requirement isn’t even required of drugs, which cavalierly are allowed to claim that they are “assumed safe for children,” for example. The second requirement on manufacturing upgrades will stifle supplement effectiveness, and as mentioned above supplements already must adhere to strict manufacturing practices and rules. The third requirement is the worst, however, as capping supplement dosage will deny life-saving treatments so important in a time of pandemic or really even any time.

And this brings forth a larger issue, the value of the FDA itself. The FDA arguably killed half a million Americans in 2020 by denying authorization for life-saving COVID-19 therapeutic treatments.[12] It has proposed supplement guidance that will deny critical supplements to a nutrient-deficient population. The National Health Federation proposes repeal of the 1962 FDA law that added “effective”-proving requirements of the sort that the Agency would like to also impose on supplements. Before the 1962 law FDA only tested safety, after which the market could buy and sell health treatments as long as consumers knew the results of such safety testing.[13] We suggest that safety testing could even be performed by non-FDA, independent private certification organizations. With safety certification provided privately, consumers no longer would experience the moral hazard of trust in a compromised and corrupted FDA brimming with conflicts of interest whose approved drugs annually kill hundreds of thousands of trusting Americans.

The FDA needs review on its continued relevance, we oppose any New Dietary Ingredient Guidance that bankrupts manufacturers with drug-like approval requirements, and we demand Congress delete Mandatory Supplement Listing from the FDA User Fee bill.

Links:
[1] https://wholefoodsmagazine.com/supplements/news-supplements/crn-survey-4-in-5-americans-use-supplements/
[2] https://anh-usa.org/fda-massive-attack-on-supplements/?iframe=1
[3] https://wholefoodsmagazine.com/news/breaking-news/dietary-supplement-listing-act-of-2022-industry-divided/?iframe=1
[4] https://wholefoodsmagazine.com/news/breaking-news/dietary-supplement-listing-act-of-2022-industry-divided/?iframe=1
[5] https://www.congress.gov/bill/117th-congress/senate-bill/4348/text
[6] https://www.naturalproductsinsider.com/regulatory/natural-products-association-sues-fda-over-nac
[7] https://www.npanational.org/news/senate-help-committee-leaders-looks-to-advance-fdasla-with-controversial-provisions/
[8] https://www.npanational.org/news/senate-help-committee-leaders-looks-to-advance-fdasla-with-controversial-provisions/
[9] https://anh-usa.org/fda-moves-toward-monopoly-medicine/?iframe=1
[10] https://healthimpactnews.com/2013/gao-report-supplements-are-safe-they-dont-kill-like-drugs-do/?iframe=1
[11] https://www.newhope.com/regulatory/trades-unite-opposition-fdas-ndi-guidance-document?iframe=1
[12] https://www.tigerdroppings.com/rant/politics/yale-epidemiology-professor-dr-harvey-risch-says-80-of-covid-19-deaths-were-avoidable/99188104/
[13] https://www.nationalreview.com/2020/09/fda-stifling-pharmaceutical-innovation/?iframe=1