Which side of our government should we believe?
Why is the FDA talking out of both sides of its mouth?
Why are thousands of supplements being targeted for elimination by the FDA?
What can Congress do about this?
First, about the health claim that wasn’t a health claim. The FDA stated that it was accepting a proposed health claim that magnesium can lower high blood pressure– but only if the claim is always accompanied by a disclaimer that the “evidence is inconsistent and inconclusive.”
This Orwellian language is simply bonkers. The science about magnesium’s role in overall heart health and in maintaining proper blood pressure is settled.[1] [2] [3] [4] The only way anyone can argue that it is “inconsistent and inconclusive” is to toss out the underlying science and most of the specific studies, which is exactly what the FDA did.[5]
Why This Really Matters
HHS and USDA surveys tell us that 52% of Americans, a majority, are deficient in magnesium. But FDA has no interest whatsoever in encouraging us to consume more of it, no matter how many lives could be saved or how many billions in healthcare costs shaved, including Medicare and Medicaid costs.
Nor is the Agency interested in telling us to consume the right kinds of magnesium. Note that most of the magnesium supplements sold in drug stores are magnesium oxide, which we cannot absorb, which makes it only useful as a laxative.
Is the FDA Protecting Americans or Big Pharma?
Why is the FDA doing this? Why is it still stubbornly blocking truthful claims about this miracle mineral, a key nutrient we cannot live without and cannot thrive without having the right amount?
The only explanation we can think of is that the agency is more concerned with protecting the profits of drug makers and the $26.3 billion antihypertensive drug market. Ex-FDA officials have stated that the FDA sees the drug industry as its client and represents its interests. This is the same agency that went after cherry and walnut growers for citing peer-reviewed studies about the well-established health benefits of those foods, which incidentally include extra magnesium!
Meanwhile…Mandatory Listing Further Threatens Supplements
This latest FDA action, accepting a claim while contradicting the claim, is only part of the continuing government war on supplements.
Mandating that every supplement product on the market register with the FDA is designed to sound harmless. But why duplicate the already existing taxpayer-funded NIH supplement label database?
Note that the Agency is planning to release an as-yet unfinished and highly contentious “new dietary ingredient guidance” that threatens access to 41,700 supplements.[6] This guidance is a power grab by the FDA in that it creates a drug-like pre-approval system for “new” supplements when the law simply called for a notification system for these products.
The purpose of the register is primarily to give the Agency a big hit list of supplements to terminate in the event they are not compliant with the New Dietary Ingredient system, akin to the drug approval process. Because drug approval costs billions on average, and nobody can afford to pay billions for approval of non-patentable natural substances, and because the FDA won’t approve supplements anyway, this is really a plan to wipe out many or even most supplements and thereby clear out drug company competition.
It is clear enough what the FDA plans to do. Only Congress, representing the public, can stop it. Congress must:
1) oppose the FDA’s current “new dietary ingredient” guidance,
2) oppose efforts to institute mandatory FDA listing for supplements, and
3) support efforts to allow the free flow of information about the benefits of supplements.
[1]Rosanoff A. Magnesium supplements may enhance the effect of antihypertensive medications in stage 1 hypertensive subjects. Magnes Res. 2010 Mar;23(1):27-40. doi: 10.1684/mrh.2010.0198. Epub 2010 Mar 12. PMID: 20228010.
[2] Qu X, Jin F, Hao Y, Li H, Tang T, Wang H, Yan W, Dai K. Magnesium and the risk of cardiovascular events: a meta-analysis of prospective cohort studies. PLoS One. 2013;8(3):e57720. doi: 10.1371/journal.pone.0057720. Epub 2013 Mar 8. PMID: 23520480; PMCID: PMC3592895.
[3] Zhang X, Li Y, Del Gobbo LC, Rosanoff A, Wang J, Zhang W, Song Y. Effects of Magnesium Supplementation on Blood Pressure: A Meta-Analysis of Randomized Double-Blind Placebo-Controlled Trials. Hypertension. 2016 Aug;68(2):324-33. doi: 10.1161/HYPERTENSIONAHA.116.07664. Epub 2016 Jul 11. PMID: 27402922.
[4] Nieves JW. Osteoporosis: the role of micronutrients. Am J Clin Nutr. 2005 May;81(5):1232S-1239S. doi: 10.1093/ajcn/81.5.1232. PMID: 15883457.
[5] Kavanaugh, Claudine. FDA Letter in Response to Petition for Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure (Hypertension). https://www.fda.gov/media/155304/download. February 24, 2022.
[6] See Dr. Joanna M. Shepherd Bailey’s report entitled, Economic Impact Statement of the FDA’s Draft Guidance for the Dietary Supplement Industry regarding New Dietary Ingredient Notifications. https://anh-usa.org/wp-content/uploads/2011/08/ANH-USA-comment-to-FDA_economic-impact-of-draft-NDI-guidance.pdf. February 24, 2022.
