FDA Needs a Lesson in Supplement Science

 

We love keeping you informed of events going on in our industry; here is a great example of changes that need to happen:

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It’s true that many people can convert beta-carotene into vitamin A. It’s also true that many people cannot. And that’s just the beginning of the errors in the agency’s new labeling guidelines. Action Alert!

The FDA’s new labeling guidelines demonstrate, in a variety of ways, how unfamiliar the agency is with the latest supplement science. For example, the FDA reckons there are no known benefits of the carotenoid pigments in fruit and vegetables other than their role in being converted to vitamin A. It says there is no evidence that Americans suffer from vitamin A deficiency—and it makes no difference whether you get it directly from preformed vitamin A or indirectly from beta-carotene.

Although it’s true that beta-carotene is converted into vitamin A in the liver, there are huge differences in the conversion rate, depending both on the individual and whether the beta-carotene is synthetic or delivered naturally (via foods or supplements).

The FDA’s new way of measuring vitamin A (mg RAE instead of IU) simply eliminates the distinction between synthetic beta-carotene and naturally derived vitamin A. ANH-USA’s scientific director, Dr. Rob Verkerk, notes that “It’s a travesty that the FDA thinks the only beneficial role of beta-carotene is its conversion—variable as it is according to its source and the individual—to vitamin A. It also appears to have completely ignored the key roles of other provitamin A and non-provitamin carotenoids.”

The result? Under the new rules, the amount of vitamin A actually derived from a supplement may be wildly different than what’s on the label.

“They’ve picked one vitamin A isomer, and they’re trying to tell us what’s equivalent to that,” integrative pioneer Jonathan Wright MD told ANH-USA. “But everyone has different enzyme systems; some people are lousy at turning beta-carotene into retinol. It’s a one-size-fits-all approach to health that doesn’t work.” Indeed, a reputable study suggests that as much as 45% of the population cannot convert beta-carotene into the vitamin A (retinol) our body needs.

The new rules will also change folate’s unit of measurement from micrograms to “micrograms Dietary Folate Equivalent (mcg DFE)”. Essentially, one mcg DFE = 0.6 mcg of folic acid, based on the idea that folic acid is much more bioavailable than dietary folate. As pointed out by Dr. Verkerk, this is a gross generalization—how well you process folate comes down to your individual biology and genetics.

Additionally, in its new rules, the FDA fails to discuss its methodological approaches to evaluating differences in bioavailability between folic acid and dietary folates—in fact, the difference cited by the FDA appears to be based largely on a single study of non-pregnant women. This is ironic because whenever the benefits of supplementation are discussed, the FDA dismisses one or more studies as inadequate evidence.

We’ve told you before about how the FDA is attempting to ban folate from dietary supplements through these new labeling guidelines, presumably to reserve this vital B9 vitamin for Big Pharma. So you can readily see the apparent contradiction here.

The agency, on the one hand, is saying that only folic acid can be on the label, which effectively bans natural folate and equivalent (polyglutamic) forms, and on the other hand is talking about how—incorrectly—to label folate.

Right now we are concentrating on lifting the effective ban on folate. It would be egregious for the government to take this natural form of a critical B vitamin away from American consumers and restrict it to drug company use. While fighting this all-important battle, we also have to point out the error in folate labeling.

In addition to vitamin A and folate, the FDA also shows a complete lack of understanding of vitamin E. For example, according to the text of the new rules, alpha-tocopherol is the only biologically active form of vitamin E.

When we told this to Dr. Jonathan Wright, he exclaimed, “What baloney!” In fact, there are eight different forms of active vitamin E, the two most important being gamma- and delta-tocopherol. A 2009 study demonstrated that gamma- and delta-tocopherols slowed the growth of breast cancer by up to 80%! And, you certainly shouldn’t ignore the four isomers of tocotrienols that have been shown to reduce neurodegeneration.

Other planned changes to dietary supplement labeling would lead to less potent and useful supplements, which in turn could lead to more national nutrient deficiencies.

The FDA—together with the quasi-governmental Institute of Medicine (IOM)—is, in practice, opposed to high levels of nutrient supplementation. The agency can’t for the time being directly limit the nutrient levels of dietary supplements (e.g., it can’t put a cap on how much vitamin D a multivitamin contains). But it can influence what is available through changes to dietary supplement labeling, including the Daily Values (DVs) listed on Supplement Fact labels (equivalent to the Nutrition Facts labels for food).

DVs are meant to be a simple percentage of how much of a nutrient you need in a day. However, since the DVs for vitamins and minerals are either based on the IOM’s extremely low Recommended Daily Values (RDVs) or Adequate Intakes (AIs), they completely discount the potential benefits of high-dose supplementation. The result is proposed DVs that are, in some cases, even lower than the EU’s Recommended Daily Allowances—and the EU is notorious for requiring extremely low nutrient levels.

To read entire article, click here: http://www.anh-usa.org/fda-needs-a-lesson-in-supplement-science/