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Stop FDA Threat to Consumer-preferred Supplements

Their "New Dietary Ingredient" Guidance will Bankrupt Thousands of Supplements, and Congress is Making it Worse

NHF campaign: 

FDA Threatens Consumer Access to Preferred Supplements

By Charles Frohman, lobbyist

July 27, 2021

 

 


Action:  Please input your zip code at the bottom of the page, to trigger the sending of NHF's letter to your U.S. Representative and both Senators. We need them to protect our supplements.


Background:  The 50% 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 health care – and during a pandemic when supplements rise in importance to save lives. Will you please oppose the unconscionable legislative or regulatory proposals for the FDA to place dietary supplements on a list for market elimination?

THIS MATTER IS VERY URGENT, because the FDA has stated it will finalize next year its draft Guidance on New Dietary Ingredients (NDIs), first proposed in 2011, which would subject more than 30,000 “new” supplements to harsh and unnecessary drug-like regulations to prove their safety.[1] We already know that supplements are about the safest consumer product someone can ingest, safer even than food. Why drive their cost up just to satisfy unnecessary and costly regulations? Many supplements will even be driven out of the market because they will not be worth the time and money to “prove” to the FDA’s satisfaction that they are safe.

The approval requirements would apply to all supplements brought to market after the passage date of the 1994 Dietary Supplement Health and Education Act (DSHEA). Further, Congress may exploit the appropriations process to insert into “must-pass” legislation language mandating a list enabling FDA to target what they label as “New Dietary Ingredients” (NDI) - that is, supplements created after the 1994 Act.[2]

The FDA proposed its 2011 guidance in a way so violative of the 1994 Act that it garnered a landslide of comments that buried the guidance for a half a decade. The Senate even allowed a related bill to have a vote, but it was defeated soundly. Not content to respect consumer preference for natural health, powerful pharmaceutical interests goaded Congress in a recent Appropriations bill to support FDA’s attack on supplements, based on a misleading 2015 U.S. Department of Health and Human Services study showing 20,000 hospitalizations blamed on supplements.[3]

What the news coverage ignores about that study are the 20% of injuries stemming 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 supplements for energy, sexual performance, or weight loss. A certain percentage stemmed from illegal ingredients. The FDA already has the authority to remove adulterated products from the market; indeed, DSHEA allows for the restriction or removal of any product it determines to be unsafe. Supplements are further regulated by the Federal Trade Commission and must also follow stringent good manufacturing practices.

Also ignored in the scare story was any context – including comparisons with drugs. 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 in one year 60,000 people – more than all dietary ingredients COMBINED. And the purported supplement-injury figure does not fit with a similar study by the U.S. General 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.[4]

Given the high safety of supplements, one cannot help but ask why the government so persistently attacks the preference of consumers for natural medicine. In the 2016 FDA redraft of the NDI rule, they threatened to implement bankrupting safety and effectiveness studies to be required whenever an old supplement is recommended for a new population, or when using new manufacturing innovations, or when proposing new doses. 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.[5,6]

Given also that the FDA’s guidance would bankrupt the supplement industry and jeopardize consumer health, why are some in Congress colluding with the FDA to mandate supplement targeting? Perhaps it stems from the FDA’s 1992 report on supplements, in which they concluded that supplements threaten pharmaceutical companies’ pursuit of patent monopolies. Or, it could be a continuation of the past year’s practice by the FDA to target with cease and desist letters those entrepreneurs who sell supplements as COVID-19 treatments.[7] It seems violative of the 1999 Shalala case – and of statutorily established significant scientific-agreement claims – for the FDA to ban dietary-supplement claims supported by credible scientific evidence.[8]

It has already happened with NAC, a decades-old supplement that just happens to represent an effective COVID-19 treatment. Out of nowhere, the FDA began issuing warning letters stating it is not a legal supplement, reserving this essential health compound for the drug industry alone.[9]

This draft guidance removes competition for Big Pharma and will allow them either to monopolize the supplement market or more likely to turn supplements into hugely expensive prescription drugs. If consumers see that politicians and bureaucrats are interfering with their supplements simply to line the pockets of the pharmaceutical companies, they will not be happy.

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 treatments. It has proposed a supplement rule that will deny natural ingredients to half the 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 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.[10] 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 has long proven itself a danger to the supplements it regulates, and to peoples’ health overall. Please oppose the FDA’s and congressional efforts to remove from the market any supplements using the New Dietary Ingredients guidance as the weapon to do so.

Action:  Please input your zip code at the bottom of the page, to trigger the sending of NHF's letter to your U.S. Representative and both Senators. We need them to protect our supplements.

 

Links:

[1] https://www.jdsupra.com/legalnews/fda-releases-priority-list-of-food-7783212/

[2] https://fda.news/2021-07-30-variants-congress-wants-dietary-supplements-prescription-only.html

[3] https://vitaminretailer.com/house-appropriations-report-ignores-strong-safety-record-of-nutritional-supplements-says-npa/

[4] https://healthimpactnews.com/2013/gao-report-supplements-are-safe-they-dont-kill-like-drugs-do/

[5] https://www.newhope.com/regulatory/trades-unite-opposition-fdas-ndi-guidance-document

[6] https://thenhf.com/2019/05/09/fda-issues-revised-draft-new-dietary-ingredient-guidance-for-supplements

[7] https://articles.mercola.com/sites/articles/archive/2021/03/15/fda-warns-dr-mercola-to-stop-writing-about-vitamin-d.aspx

[8] https://cohenhealthcarelaw.com/2018/08/how-to-respond-to-an-fda-warning-letter-about-dietary-supplements-or-cosmetics/

[9] https://deitexercise.wordpress.com/2020/09/03/fda-wants-to-ban-nac-now-that-it-combats-covid-19/

[10] https://www.nationalreview.com/2020/09/fda-stifling-pharmaceutical-innovation/


The National Health Federation (NHF) is the World’s oldest 501(c)(4) health-freedom organization, having since 1955 defended food and healthcare from government distortion and special-interest corruption.  For questions see https://thenhf.com/2020/11/03/who-is-nhf/ or  contact Charles.Frohman@theNHF.com



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