The Alliance For Natural Health

FDA Needs a Lesson in Supplement Science


Alternative Medicine.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.

New DVs for Vitamins and Minerals: From “Abysmally Low” to Catastrophically Low

According to ANH-USA board member Dr. Ron Hoffman, the FDA’s newly proposed DVs are like “rearranging the deck chairs on the Titanic—it looks like they’re arbitrarily reshuffling nutritional standards that, by and large, are abysmally low.”

The FDA has proposed lower DVs for riboflavin, despite the fact that this vitamin is crucial to absorbing other nutrients, and nearly impossible to overdose on. The same “logic” (or lack thereof) has also been applied to the FDA’s new recommendations for vitamins B12 and B6. The toxicity potential for B12 is so low, not even the IOM could set an Upper Limit for it, but the recommended amount is lowered anyway to a miniscule 2.4 mcg. This would mean that a 5,000 mcg/day vitamin B12 product would have to be labeled at 208,333% of the DV—this might make some think this level would be too high or even dangerous, despite no evidence that it would do anything other than good to the vast majority of people.

By using inappropriate science, and ignoring the latest nutritional and nutrigenomic science, the DVs for zinc, B12, and B6 are being lowered. This is despite evidence that these deficiencies are quite common. B12 deficiencies, for example, affect up to 15% of the population and are often exacerbated by drug intake (e.g. over-the-counter antacids like Prilosec and Zantac can cause serious 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 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), the FDA is lowering the DVs for biotin and chromium—two nutrients critical for blood sugar control.

Selenium, copper and zinc are mineral powerhouses that fuel key antioxidant enzymes in the body. Selenium’s new DV is particularly low—just 55 micrograms, which is identical to the EU level (leading integrative MD Jonathan Wright recommends 200 mcg daily for disease prevention). Without these nutrients, your body’s free-radical defense system can be significantly compromised. And, with the nutrient content of our food dropping dramatically (vegetables have 76% less copper than they did in 1940), these minerals are more vital than ever.

FDA is also lowering the DVs of pantothenic acid, sometimes known as vitamin B5. This vitamincan help your body to better manage adrenal stress and regulate blood lipids. Pantothenic acid, in any known dose, is not toxic to humans.

The Higher DVs Are Nothing to Celebrate

While the slightly increased DVs for vitamins C and D, as well as magnesium, are a welcome step in the right direction, they are still woefully insufficient:

  • Vitamin C has been raised to 90 milligrams; the Life Extension Foundation recommends between 400 and 1,000 milligrams a day.
  • Vitamin D has been raised to 800 IU (20 mcg). The ideal amount varies depending on weight and personal chemistry, but at least 1,000 to 5,000 IU a day is usually needed to keep vitamin D in the optimum range (as measured by a blood test accepted by conventional medicine).
  • Magnesium has been raised to just 420 milligrams; the optimal amount again varies greatly by individual and lifestyle, but is closer to at least 500 milligrams and can be considerably higher for athletes.

On the downside, the DV for calcium has been raised by 30%, despite the fact that excess calcium may promote arterial calcification. This is particularly true if it’s not taken with such key co-factors as vitamin K2 and vitamin D, as well as an appropriate, balancing amount of magnesium.

If the FDA wishes to reform its DVs, it should look at all the available relevant nutritional science, including how nutrients interact with cofactors, differences between synthetic and natural forms, and malabsorption issues and genetic polymorphisms that affect many Americans.

Changes to Vitamins’ Units of Measure

The FDA is also proposing changes to the units used for the amounts of vitamins A, D, and E in supplements.

These fat-soluble vitamins’ units of measure are changing from International Units (IU) to new, nutrient-specific measurements. Some of this is a good idea. The trouble with measuring vitamin D in IU is that each IU is unique to that vitamin. This can be confusing.

People naturally think that 10,000 IU of vitamin D is equivalent to 10,000 IU of vitamin A, but it isn’t. Moreover, the IU measurement scale of vitamin D happens to have used high numbers.

Since IU is an arbitrary scale, 5,000 IU could just as easily been expressed as 50 IU, even though it’s the same amount. 5,000 IU of vitamin D expressed in micrograms is 125 mcg, which does not sound as intimidating and is the amount many adults should be taking daily if they’re not exposed to sunlight at the right hours and right seasons. However, these smaller numbers may also make consumers believe they need less vitamin D than before, and add an extra layer of confusion for consumers attempting to understand valuable research done before the conversion.

If the FDA stopped there and just converted IU to mcg, it would all be well and good, but of course it plans to do much more with vitamins A and E, as discussed above. In addition, the change to mcg and mg is another indicator of the FDA’s wish to “harmonize” with Europe, where these measurements have been used for years.

We’ll be heavily criticizing the FDA in our submission to their proposed rule that will be submitted before the deadline closes on June 2. Even more importantly, we’ll be explaining why these labeling changes could be so damaging to the health of Americans, why the nutritional science the FDA has relied on is out-of-date, and how labeling can be improved to ensure citizens and health professionals are given all the information they need to make informed decisions about their health.

With this New Labeling Scheme, Who Wins?

Big Business. First, these DV changes could save the makers of fortified foods and Big Pharma’s bargain-basement supplements millions of dollars. For example, Kellogg can put less vitamin B12 in its Special K, but still say it contains 100% of your DV.

Fans of Codex and EU Harmonization. The changes in units of measurement for folate, niacin, and vitamin A harmonize FDA regulations with Codex’s guidelines on nutrition labeling. Additionally, the changes in DVs are, according to our colleagues at ANH-Europe, a “clear signal of a strong desire by the FDA to edge ever closer to the much more restrictive approach long associated with European regulation.”

Synthetic nutrients and medicines. The FDA’s nutrient conversions are a sneaky way of valuing synthetic nutrients over natural ones: by using synthetic nutrients as the “gold standard,” the FDA ignores the potential benefits of natural nutrients for many individuals—especially those unable or less able to convert synthetic nutrients into forms the body can use.

How These Changes Will Affect You

How much of a nutrient your body absorbs varies greatly depending on your individual biochemistry and genetics, availability of nutrient co-factors, the soil the food was grown on, how you cook or prepare it, and where you’re getting your nutrients. To use a one-size-fits-all approach is not only misleading—it could very well be dangerous.

According to Dr. Ron Hoffman, these labeling changes can potentially have “a negative health impact for the tens of millions of Americans who live on the cusp of nutritional insufficiency.” For consumers who are new to or not well-versed in supplementation, 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 it clearly isn’t optimal for most.

It’s good that the FDA is attempting to revise outdated DVs. However, the disastrous ramifications of lowering vital nutrients’ DVs far outweigh any benefit derived from the insignificant increases in some nutrients.

This new supplement label guidance once again reveals that the FDA is not only hostile to supplements and biased in favor of drugs—it is also woefully lacking in an understanding of the science of supplements.

In this context, it is noteworthy that the FDA has now been put in charge of farms and farmers by the recent Food Safety Modernization Act. As we have also pointed out, this agency knows absolutely nothing about farming, and is already trying to push around small organic farmers and limit their use of natural farm manures.

What is really needed here is to split up the FDA into three agencies, one each for drugs, food, and supplements. That way an agency that is currently all about drugs and whose budget is supported by drug companies could begin to learn something about food and supplements.

Action Alert! The FDA’s labeling changes show a poor understanding of supplement science, will confuse consumers, and could endanger the long-term health of Americans, most of whom are teetering on the edge of one form of nutritional deficiency or another. Write to the FDA TODAY, and ask it to revise its new standards for DVs.


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