BEWARE the FDA‘s latest plan to “help” dietary supplement consumers

“I’m from the government and I’m here to help you.” Once again, the U.S. Food and Drug Administration (FDA) has set out to prove that these are the 10 most worrisome words in the English language.

What is the FDA up to this time? It’s recommending changes to the Nutrition Facts labels you see on food packages and the Supplement Facts labels you see on dietary supplements.

On the surface, this seems pretty harmless—perhaps even helpful. For instance, the FDA wants food labels to reflect realistic serving sizes and to state how much sugar has been added to a product.

But hidden in all the FDA’s self-aggrandizing PR about how these new labels will make your life better are some proposed changes that could seriously affect your health.

Bottom line: The FDA wants to reduce its recommended Daily Values (DVs) for nutrients you literally cannot live without.

When less isn’t more

That’s right—the FDA actually wants you to take fewer B vitamins, copper, selenium, chromium, and zinc. Nutrients that fight cancer, prevent cognitive impairment, give you energy, help you manage stress, lower your cholesterol, and balance your blood sugar.

So how does this translate into a Nutrition Facts label? Let’s say the label on a carton of skim milk says a serving of that milk contains 20 percent of the vitamin B12 you need each day. But if the FDA gets its way, the new label will say that a serving gives you a larger percentage of B12.

Sneaky, right? By lowering the DV for vitamin B12 and other nutrients, the FDA will make you think you’re getting more of those nutrients per serving of food, when instead, you’re actually getting fewer.

This plays right into Big Food’s hands. Manufacturers can save millions of dollars with lower doses of nutrients in their “fortified” foods and still claim they’re providing 100 percent of the recommended DVs.

The same reasoning applies to Supplement Facts labels. On a multivitamin, for instance, the current label may say that one serving contains 100 percent of your DV for vitamin B12. But if the FDA succeeds in lowering the B12 DV, your multivitamin could say you’re getting a percentage of B12 that’s so high, it can seem dangerous.

Of course, that’s good news for big pharma, which can then get away with even smaller doses in its already-useless daily multivitamins.

And in the end, the new DVs will further the FDA’s long-held stance that dietary supplements “don’t work,” because the proposed doses will be even more inadequate.

The FDA’s recommended DVs for the dietary supplements you use every day have always been shockingly low. But if this government agency has its way, they will soon be catastrophically low.

Granted, the FDA is proposing that DVs for magnesium and vitamins C and D be increased. But the new levels are still woefully insufficient according to the latest research.

This new labeling initiative boils down to the fact that the FDA remains ignorant, if not outright hostile, to dietary supplementation to prevent diseases. It’s sad but true: Even with the tens of billions of tax dollars spent every year on health research, the government-industrial-medical complex remains willfully in the dark when it comes to basic human biology, diet, and nutrition.

But the news is not all gloomy. You still have time to take action against the FDA’s proposed new food and supplements labels (see “Make your voice heard” below)

Here’s what you need to know to make an informed comment about the FDA’s catastrophic new labeling plans.

A lesson in Daily Values

The FDA’s recommended Daily Values are meant to provide a simple guideline on how much of a nutrient the average adult needs each day. But the government relies on nutritional science that is hopelessly out of date to set these DVs. In fact, in many cases, research shows DVs should be substantially higher than what federal bureaucrats believe.

The FDA’s proposed labeling changes are ostensibly meant to update “outdated” DVs. But for consumers who are not well versed about dietary supplementation, the new DVs are shamefully misleading.

As my friend and colleague Dr. Ron Hoffman says, the proposed new 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.”

Basically, the FDA is proposing three key changes to the recommended DVs on food and supplements labels. Each of these changes is a giant step backwards for nutritional science. Not to mention good health for all Americans.

Change #1: B vitamins and minerals

The FDA has proposed lower DVs for vitamin B2 (riboflavin) despite the fact that B2 is essential for helping the body absorb other key nutrients—and it is nearly impossible to get too much of it.1

The FDA also wants to cut DVs for vitamins B6 and B12. Even though the potential toxicity of B12 is practically nonexistent. (The threat is so low, the Institute of Medicine never set an upper limit for it.) Plus, research shows that 39 percent of the population doesn’t get enough of this key vitamin.2 Vegetarians and people who take over-the-counter antacids or the diabetes drug Metformin are particularly prone to B12 deficiency.

Inadequate levels of vitamin B12 can cause weakness, fatigue, bruising, and stomach problems. Severe deficiency may lead to anemia, cognitive impairment, depression, and nerve damage.

Vitamin B6 deficiency often appears together with B12 deficiency. A lack of B6 may lead to anemia, confusion, depression, and impaired immune function.

The FDA also wants to lower the DV for two other B vitamins—B5 (pantothenic acid) and biotin (vitamin B7).

Vitamin B5 is key for helping your adrenal glands manage stress, and can also lower cholesterol. There is no known dose of B5 that is toxic to humans.

Biotin is important for balancing blood sugar. In the midst of our modern diabetes epidemic, reducing the biotin DV is incomprehensible.

In addition, the FDA wants to change how folate (vitamin B9)is listed on dietary supplement labels. It’s complicated, but this change could effectively ban natural folate from supplements and restrict it to drug company use. I will tell you more about how this ploy is playing out in a future article.

For now, suffice it to say that if the FDA succeeds with its folate plan, it would be a major loss to natural health because not only does this critical vitamin help prevent birth defects, but it has also been shown to fight cancer and depression.

Unfortunately, the FDA isn’t stopping its DV-lowering mania with B vitamins, either. It’s also targeting the essential minerals copper, selenium, zinc, and chromium.

Like biotin, chromium is key for balancing blood sugar. And selenium, copper, and zinc fuel key antioxidant enzymes in the body.

There is also abundant evidence of selenium’s benefits in preventing cancer and other chronic diseases,yet the FDA still wants to lower the DV to just 55 mcgs.3 (This dose, incidentally, is identical to the level set the by world’s ultimate bureaucracy—the European Union). While it certainly is possible to get toxic doses of selenium, I believe that 200 mcg a day is more appropriate for disease prevention.

Change #2: Vitamins C and D, magnesium, and calcium

As I mentioned earlier, the FDA is proposing increased DVs for several nutrients—vitamins C and D, magnesium, and calcium. Unfortunately, these supposedly “improved” dosages are still negligently low.

The proposed new DV for vitamin C is 90 mg. However, some experts recommend as much as 2,000 mg daily of this key nutrient. A dose that has been shown to help boost immunity and prevent cardiovascular disease, cancer, cataracts, and gout. And because your body routinely flushes out any excess vitamin C, it’s difficult to overdose on this vitamin.

In the face of a long-standing national epidemic of vitamin D deficiency, the FDA has finally decided to raise the DV for this powerhouse nutrient to 800 IU. But the ideal amount of D, which research shows helps prevents everything from cancer to depression, is at the very least 2,000 IU a day, increasing to 5,000 IU depending on your weight and metabolism.

The DV for magnesium, which can reduce the risk of cardiovascular disease, type 2 diabetes, and osteoporosis, is being raised to 420 mg. The optimal amount varies greatly by individual and lifestyle, but is generally closer to 500 mg a day.

And then there’s calcium—the only nutrient DV that the FDA has actually increased too much, apparently not understanding that the only way to get optimal calcium is from the diet.  Trying to formulate or take appropriate levels of calcium supplements is a fool’s errand—and yet, the industry is full of useless calcium supplements.

The FDA proposes boosting the calcium DV by 30 percent, despite well-documented evidence that too much of this mineral may increase the risk of cardiovascular disease—especially if it’s not taken in the appropriate form or isn’t accompanied by enough magnesium and vitamins D and K2.4

Change #3: Vitamins A and E

The FDA’s proposed alterations to how vitamin A and E are labeled on dietary supplement containers seem subtle. But the effects are definitely far from subtle.

The FDA wants to measure vitamin A in a new way that eliminates the distinction between synthetic and naturally derived versions of the vitamin. But because synthetic vitamin A metabolism varies substantially among people, you might not be getting the actual amount of the vitamin the supplement label says you are.

For vitamin E, the FDA plans to only recognize one form: alpha-tocopherol. But there are actually eight different active forms of this remarkable vitamin. Failure to use these different forms in some studies has led to false alarms about the “risks” associated with vitamin E (most notably a supposed increased risk of heart disease).

But studies that have used the proper forms (by way of a mixed tocopherol supplement) and adequate doses of vitamin E have shown that the vitamin can substantially reduce serious threats like breast cancer and Alzheimer’s disease.5,6

Overall, the proposed new FDA Nutrition Facts and Supplement Facts labels appear to fly in the face of the latest nutritional and genetic science, or simply use inappropriate science. And that not only puts your health at risk, but also moves the country backwards in terms of recognizing the need for improved dietary supplementation.

The FDA needs to be stopped. Protest these disastrous changes to the labeling laws today and let the government know you can live—and thrive—better without its misguided “help.”

 


 

Nutrient DV Optimal dose based on the latest research
Vitamin B2 (riboflavin) 1.3 mg 50 mg
Vitamin B6 1.7 mg 50 mg
Vitamin B12 2.4 mcg 100 mcg
Vitamin B5 (pantothenic acid) Less than 5 mg 50 mg (but there is no upper level that is known to be unsafe)
Vitamin B7 (biotin) 30 mcg 15,000 mcg
Folate 400 mcg 400 mcg
Vitamin A 3,000 IU 15,000 IU
Vitamin E 15 mg 2,000 mg (mixed tocopherols)
Vitamin C 90 mg 2,000 mg
Vitamin D 800 IU 2,000-5,000 IU
Chromium 25-30 mcg 450 mcg
Selenium 55 mcg 200 mcg
Copper 900 mcg 1 mg
Zinc 8-10 mg 35 mg
Magnesium 420 mg 500 mg
Calcium 1,200 mg There is no calcium supplement that is safe and effective. You must get calcium from food: dairy, eggs, fish, meat.

 

Make your voice heard

Let Big Bureaucracy know that you won’t stand for reduced daily values of dietary supplements that are scientifically proven to fight disease and save lives.

You can comment online at http://www.regulations.gov or by mail at:

Division of Dockets Management (HFA-305)

Food and Drug Administration

5360 Fishers Lane, Rm. 1061

Rockville, MD 20852

Make sure to include “FDA Docket No. FDA-2012-N-1210” and “RIN 0910-AF22” on any mailed comments.

Sources:

1University of Maryland Medical Center. Vitamin B2 (Riboflavin). http://umm.edu/health/medical/altmed/supplement/vitamin-b2-riboflavin. Accessed April 21, 2014.

2 Tucker KL, et al. Plasma vitamin B-12 concentrations relate to intake source in the Framingham Offspring study.Am J Clin Nutr. 2000 Feb;71(2):514-22.

3 El-Bayoumy K. The protective role of selenium on genetic damage and on cancer (Review). Mutat Res 2001;475:123-39.

4Bolland MJ, et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 2010;341:c3691.

5 Zhong S., et al. Dietary crotenoids and vitamins A, C, and E and risk of breast cancer. J. Natl. Cancer Inst. 91 (1999) 547-556.

6 Dysken, MW, et al. Effect of Vitamin E  and Memantine on Functional Decline in Alzheimer Disease – The TEAM-AD VA  Cooperative Randomized Trial. JAMA. 2014; 311(1): 33-34.