Monday, June 06, 2022

Federal Dietary Supplement Registry bills

 Dietary Supplement Legislation Misguided & Inflationary

A bill sponsored by Senators Durbin (D-IL) and Braun (R-IN) - S.4090, the Dietary Supplement Listing Act - mandates a registry of all dietary supplements, citing safety concerns. Meanwhile, the Senate Health, Education, Labor, and Pensions (HELP) Committee also added mandatory product registration for this non-drug category to must-pass prescription drug user fee legislation S.4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA). 

These concerns are overblown; the proposed solution draconian. Why treat an overwhelmingly safe food category as inherently dangerous? Multivitamins, vitamin C, calcium, fish oil, and common nutrients are non-toxic, with few safety concerns.

Senator Durbin uses Adverse Event Reports (AERs) as justification. But Mr. Durbin knows AERs are defined as associative, not proof of a causal relationship. I manage a team handling dietary supplement AERs for a responsible manufacturer, which are promptly investigated and reported to the FDA. The few AERs we receive are typically caused by pre-existing conditions/known drug effects, not supplements. And many dietary supplement AERs received by FDA involve multivitamin choking issues, not toxicity. 

There are potential interactions between certain ingredients and certain drugs. A published report of Mayo Clinic patient records identified only five such ingredients, noting only minor negative drug interactions. Statistics from the authoritative American Association of Poison Control Centers confirm zero deaths are associated with dietary supplements most years. Official AERs, not necessarily caused by supplements, showed only 166 hospitalizations and 22 deaths over an 11-year, 4-month period. By contrast, CDC estimates 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths from foodborne diseases each year; food allergies cause 15 million illnesses, 30,000 ER visits and 150–200 deaths. Taking a dietary supplement is statistically far safer than eating a meal. 

If there is a safety issue, FDA already has the power to ban products, as it did with the herb ephedra. Facility registration is already mandated in existing Bioterrorism and Food Safety laws, but S.4090 inexplicably removes carefully designed antiterrorist protections. The National Institutes of Health already have a huge dietary supplement label database, which the FDA seeks to duplicate in a wasteful agency rivalry. 

S.4090 imposes large fines - and jail terms - for not getting advance bureaucratic permission to market any supplement, even vitamin C. Companies must seek registration numbers and identify individuals to be severely penalized for infractions, with sales restricted by agency refusal or delay. Why does the FDA need absolute veto power over every vitamin; adding red tape and inflationary costs? The FDA already has statutory authority to inspect manufacturers, review labels and batch records, and confirm AERs are being properly handled/reported. Since the rationale is lack of enforcement of existing laws, how does piling on new regulations, fees, and harsh penalties solve that persistent agency problem? An analogy: would new laws lowering the speed limit and requiring drivers to keep mileage logs stop speeders, or is enforcement the real solution? 

The dietary supplement industry welcomes reasonable consumer protections. We supported laws giving FDA authority over ingredients, label claims, Good Manufacturing Practices (GMP), facility inspections, food safety practices, facility registration, adverse event reporting, steroid bans, and allergen labeling. We’ve repeatedly lobbied Congress for higher FDA enforcement budgets to weed out bad actors, but oppose universal pre-market approval.

Why is a safe food category – dietary supplements – targeted for harsh regulation and higher costs, strangling innovation and consumer needs? If safety is the issue, why shouldn’t riskier food manufacturers (allergens and food poisoning) also need pre-market approval, their employees targeted for prosecution and fines? This is a punitive bill targeting an overwhelmingly safe product category for no justifiable reason. 

Neil Edward Levin, CCN, DANLA

NOW Health Group

Bloomingdale, Illinois

Thursday, May 19, 2022

North Macedonian medical conference presentation

 I'm giving a remote presentation tomorrow morning 5-20-2022 at the Macedonian Association of Internal Medicine conference I'm listed on page 7 of the program.

Wednesday, January 12, 2022

Methylfolate versus folic acid for MTHFR polymorphisms

Methylfolate is a very expensive pharma-patented ingredient in a supplemental form that is not generally required by people. Even those with genetic polymorphisms can convert folic acid to methylfolate, though less efficiently due to their genetic differences, and still benefit from folic acid supplementation. 

Since a main concern with MTHFR polymorphisms is the production of less active forms of the MTHFR enzyme due to genetically driven variations in its composition (such as the substitution of alanine with valine), the polymorphisms are most noted for increasing the need for folates (of any form, rather than a particular form). This is because higher quantities of these weaker MTHFR enzymes are needed to compensate for their lower activity levels and methylfolate is a cofactor in the enzyme production, so more dietary folic acid or folates are also needed. 

The medical literature on folic acid has been misrepresented on the Internet to falsely imply that folic acid will not work in individuals with MTHFR polymorphisms. But even people with the most severe polymorphisms can still convert folic acid to methylfolate and eliminate signs of folate insufficiency, particularly high homocysteine levels, according to clinical trials. Here is one example where increasing folic acid intake for individuals with these polymorphisms resolved the problem of high homocysteine levels caused by their weaker MTHFR enzymes:

The folic acid was converted to methylfolate and utilized by these study subjects to make more of these enzymes, which is needed to resolve the health concerns over high homocysteine levels, despite the subjects having polymorphisms that cause weaker versions of the enzymes to be produced. 

The CDC is even more direct, reporting, “You might have read or heard that folic acid is not safe if you have one or two copies of the MTHFR C677T variant. This is not true. Even if you have one or two copies of the MTHFR C677T variant, your body can safely and effectively process the different types of folate, including folic acid.”

So the widespread myth that people with MTHFR polymorphisms cannot process folic acid has been disproven in authoritative research showing that they actually need to increase folic acid intake (or methylfolate intake) to produce enough of the weaker enzymes to resolve the health concerns, including elevated homocysteine levels and potential neural tube defects in their offspring.