ANH-USA: Tell the FDA to Revise Their New Supplement Labeling Standards!

Tell the FDA to Revise Their New Supplement Labeling Standards!

The FDA has proposed new supplement labeling standards that reveal poor understanding of supplement science and lower Daily Values (DVs) for foods and dietary supplements. These changes to dietary supplement labeling would lead to complete confusion about how much vitamin A you are getting, as well as less potent supplements—these changes could make the national epidemic of nutrient deficiencies worse.

Please write to the FDA and ask them to review their new standards!

And if you missed our ultra-urgent alert on the attempt to ban folate from supplements buried in these new rules, please take action on that here.

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Stephen Ostroff

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Docket No. FDA-2012-N-1210

Dear [Decision Maker],

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As an informed consumer, I was extremely disappointed by the FDA's newly proposed dietary supplement labeling standards.

The FDA has proposed lower DVs for riboflavin, despite the fact that it's crucial to absorbing other nutrients, and nearly impossible to overdose on. The same "logic" has also been applied to the FDA's new recommendations for vitamins B12 and B6 - in fact, the toxicity potential for B12 is so low, not even the IOM could set an Upper Limit for it. I call on the FDA to evaluate more recent science that evaluates the effects of high doses of nutrients from foods and supplements, as well as looking at clear differences between synthetic and naturally occurring vitamins.
It's unclear why the DVs for zinc, B12, and B6 are being lowered, when deficiencies in these vitamins are quite common (e.g. B12 deficiencies affect up to 15% of the population) and are often exacerbated by drug usage (e.g. over-the-counter antacids like Prilosec and Zantac can cause B12 deficiencies).

B6 deficiencies, which often appear in conjunction with B12 deficiencies, are associated with microcytic anemia, scaling on the lips, cracks at the corners of the mouth, depression, confusion, and weakened immune function.

Mild B12 deficiencies can result in weakness, tiredness, pale skin, easy bruising or bleeding, and stomach problems. Severe B12 deficiencies can have alarming side effects, including cognitive difficulties, paranoia, and hallucinations, and can contribute to depression, nerve damage, and dementia.

Since animal products are the main sources of dietary B12, vegans and vegetarians are especially prone to B12 deficiency. The Vegan Society recommends vegans take a daily B12 supplement of 10 micrograms -- that's over four times the amount of the FDA's DV! It's incomprehensible that the FDA would lower the DV for nutrients that are critical to health, vital to special subpopulations, and that are harmless, even when over-consumed.

In the midst of an epidemic of metabolic syndrome and Type II diabetes (35% of the American population has pre-diabetes; 8.3% have diabetes), your agency is lowering the DVs for biotin and chromium -- two nutrients critical for blood sugar control. In addition, you're lowering the DVs of pantothenic acid, a B5 vitamin that can help manage adrenal stress and regulate blood lipids. Pantothenic acid, in any known dose, is not toxic to humans.

I see that the DV for calcium has been raised by 30%, despite the fact that excess calcium may promote arterial calcification, particularly if it's not taken with appropriate, balancing amounts of magnesium (other essential co-factors for calcium include vitamins K2 and D). If your agency wishes to reform its DVs, you shouldn't look at nutrients out of context: you should always consider their necessary co-factors as well as taking into account differences in bioavailability of different nutrient forms and the effects of genetic polymorphisms.

Your proposed rules say that alpha-tocopherol is the only biologically active form of vitamin E. This is patently incorrect: there are eight different forms of active vitamin E, the two most important being gamma- and delta-tocopherol. In fact, a 2009 study demonstrated that gamma- and delta-tocopherols slowed the growth of breast cancer by up to 80%. The fourtocotrienol isomers can also not be ignored, particularly given compelling evidence that reduce the rate of neurodegeneration.

In addition, your new calculation for vitamin A (from IU to mg RAE) fails to distinguish between synthetic beta-carotene and naturally derived beta-carotene in foods and plant concentrates. It is simply untrue that the only known benefit of beta-carotene is linked to its conversion to vitamin A or that vitamin A deficiency is not evident among Americans. I am concerned that under the proposed new rules, the amount of vitamin A that could be derived from a supplement may be seriously at odds with what's on the label.

These labeling changes could have a negative health impact for the tens of millions of Americans who live on the cusp of nutritional insufficiency. For most consumers, the new DVs will be woefully misleading. For example, consumers may think a supplement or food with a 100% DV of vitamin D is sufficient, when a more appropriate amount would read on the label as 125% to 625% of your DV!

It's good that the FDA is attempting to revise outdated DVs. However, the disastrous ramifications of confusing the role of beta-carotene and vitamin E and lowering vital nutrients' DVs far outweigh any benefit derived from the insignificant increases in some nutrients.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]