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Orthomolecular Medicine News Service, January 7, 2014

Regulation of Vitamins: Politics As Usual

Commentary by Rolf Hefti

(OMNS Jan 7, 2014) Medical politics has been pervaded with unfounded, misleading arguments, tantamount to propaganda, instead of good evidence. Over the last several decades, the US mainstream medical establishment and the public health authorities, along with the help of the medical industry-sponsored mass media, have launched and broadcast numerous campaigns touting the value of firmer supplement rules for the American people [1].

The justification usually given is the lack of formal product testing for safety and efficacy, which, it is claimed, makes vitamins a big public health threat. If supplements were to be approved as prescription drugs by the public health authorities (meaning the FDA), this might prevent the alleged danger to the public [2]. After all, the public has been led to believe that medical products approved by the US government are safe and effective.

These anti-vitamin politics are exemplified in recent mainstream media releases. For example, an article titled "So Many Supplements, So Little Regulation" suggested that a pressing need exists for stricter regulation of vitamin supplements [3]. It attempted to make a case for better supplement policies because of grave safety issues. Some food supplements have been found to contain drugs that should require a prescription. However, unlike the platitudes offered by medical officialdom in favor of tougher vitamin regulations, the facts tell a different story.

Supplements Are Very Safe

Annual reports of the American Association of Poison Control Centers over the last three decades clearly show that nutritional supplements are much safer than over-the-counter drugs, even aspirin. Vitamin supplements aren't harmful like drugs. Even though vitamin supplements are not regulated as drugs, vitamin supplements also don't cause deaths . . . at all [4]. So, the claim that vitamin supplements are a significant danger to public health is wrong.

The Real Culprit

On the other hand, prescription drugs, properly taken (never mind poisoning by improper intake) are a major cause of death in the US, killing well over 100,000 people every year [5,6,7]. This is a major public health threat. FDA approved, firmly regulated drugs are causing gigantic harm to the public. Why, then, the brouhaha about FDA "safety" approval of vitamins? It's evident that the public knows the terrible safety record of prescription drugs and is concerned about it. Many drugs are very unsafe. And the FDA drug review procedure that tests drugs for side effects and sets the allowable usage is flawed.

The depiction of US healthcare by the aforementioned article should have read, "So Many Supplements, So Little Regulation, So Little Harm." And, most importantly, it should have pointed out the big threat to public health by stating, "So Many Medical Drugs, So Much Regulation, So Much Harm." Instead, the article resorted to disinformation about vitamins, accommodating the standard party line in disease care. The pharmaceutical industry and their colleagues in the medical profession demand a high standard of proof of safety for food supplements but evidently have not attained this for their own medical products.

"The foxes are guarding the hen-house. Pharmaceutical companies submit their own safety studies for FDA approval of a new drug. Drug companies have paid billions of dollars in fines for unethical practices and documented direct harm, including deaths, among other side effects. The public's confidence in the FDA is undeserved." (Ralph Campbell, M.D.)

The highest standard of proof of safety (and efficacy) is testing in the real world, where vitamins are safe and effective at preventing disease and improving health. The FDA's product safety approval process neither prevents nor eliminates grave threats to public health [8,9]. Clearly, there exists urgency and necessity to protect public health from the hazards of prescription drugs. In contrast, there is little urgency or necessity for more rigorous regulation of vitamin supplements as drugs. The endless string of crusades for more vitamin regulations indicates political and profit motives are likely involved.

Profit Pushes Politics

Human history all too often repeats itself. The mode of repetition centers mainly around power, domination, and greed - and widespread public ignorance and indifference about their nature and influence - leading to a vicious cycle of injustice and war. In the healthcare industry, the dominant player is orthodox medicine. A variety of therapeutic modalities (for instance, nutritional medicine) are minority players. In recent decades, alternative medicine has experienced massive expansion [10,11]. This development is in large part due to new rules implemented by the U.S. Congress in 1994 that gave the American people unrestricted access to vitamin supplements, facilitating industry growth.

Concurrently, for more than two decades the pharmaceutical-medical industry (orthodox medicine) has been a major influence on the FDA, with their own help from Congress [12]. This put the government in a conflict-of-interest situation: the industry the FDA is supposed to regulate by law is also, at the same time, paying the agency enormous sums of money. This resulted in the FDA increasingly making decisions favorable to the medical-pharmaceutical industry, supporting that industry's self-serving "disease care" interests [1,9]. From its inception, the overriding interest of organized medicine has been to generate profits and to assure its monopoly status in healthcare Over the last 100 years, medicine has had a history of ostracizing relevant competitors who encroach on the profits in its bottom line [13-15]. Throughout much of that history, the FDA has been a willing assistant and enforcer of the medical profession's profit interests [1,12,16].

Thus the nonsensical attempts and bogus arguments presented by the ruling medical elite in support of firmer vitamin laws, under the pretext of "protecting public health", are in reality attempts to stifle, diminish, and eradicate the booming supplement industry [1]. These specious motions are acts of injustice to the public. After all, the contrived campaigns are rock-solid evidence of politics.

Capricious anti-supplement crusades will never be in the best interest of American health, simply because the foxes guard the henhouse. Many people call it a scam. I call it a repetition of the history of organized medicine.

(Rolf Hefti is an independent investigator, author, and the founder of )


1. Emord JW, "The Rise of Tyranny", Sentinel Press, 2008. ISBN-13: 978-0982059500

2. Angell M, Kassirer JP, "Alternative medicine: the risks of untested and unregulated remedies", N Engl J Med. 1998 Sep 17;339(12):839-41.

3. Scutti S, "So Many Supplements, So Little Regulation",, 15-Nov-2013,

4. Saul AW, "No Deaths from Vitamins. None." Orthomolecular Medicine News Service, January 3, 2014.

5. Lazarou J, Pomeranz BH, Corey PN, "Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies", JAMA, 1998 Apr 15;279(15):1200-5.

6. Dean C, Feldman M, Rasio D, Smith D, Null G, "Death By Medicine", Independent review commissioned by the Nutrition Institute of America, 2003.

7. Leape, LL, "Errors in medicine.", Clinical Chimica Acta, 2009 Jun;404(1):2-5. Epub 2009 Mar 18.

8. Abramson J, "Overdosed America: The Broken Promise of American Medicine", 2008. Harper Perennial; ISBN-13: 978-0061344763

9. Light DW, Lexchin J, Darrow JJ, "Institutional corruption of pharmaceuticals and the myth of safe and effective drugs", J Law Med Ethics. 2013 Fall;41(3):590-600.

10. Koplan JP, Annest JL, Layde PM, Rubin GL, "Nutrient intake and supplementation in the United States (NHANES II)", Am J Public Health. 1986 Mar;76(3):287-9.

11. Bailey RL, Gahche JJ, Lentino CV, Dwyer JT, Engel JS, Thomas PR, Betz JM, Sempos CT, Picciano MF, "Dietary supplement use in the United States, 2003- 2006.", J Nutr. 2011 Feb;141(2):261-6.

12. Angell M, "Taking back the FDA", The Boston Globe, 26-Feb-2007

13. Coulter, HL, Divided Legacy, Volume III: Science and Ethics in American Medicine, 1800-1914. North Atlantic Books; 2nd edition (1993) ISBN-13: 978-0913028964

14. Carter JP, "Racketeering in Medicine: The Suppression of Alternatives", 1992. Hampton Roads Pub, ISBN-13: 978-1878901323

15. Aaron C, Lincoln T, "The Other Drug War 2003: Drug Companies Deploy An Army Of 675 Lobbyists To Protect Profits.", Washington (DC): Public Citizen Congress Watch; June 2003. Available: [accessed Dec-2013]

16. Lewis H, "Crony Capitalism in America 2008-2012", 2013. AC2 Books ISBN-13: 978-0988726727

For further reading:

A more detailed, lengthier version of Rolf Hefti's article is available on his website at

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Ian Brighthope, M.D. (Australia)
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