Protect Free Speech About Natural Products

The Food and Drug Administration (FDA) recently released a “guidance” describing the substantiation needed by infant formula products to make structure/function claims. In the guidance, the FDA “recommends” that double-blind randomized controlled trials (RCTs) be used to substantiate structure/function claims on these products.

In other words, infant formula should be treated like drugs.

This latest move has implications far beyond infant formula products. The FDA is putting all natural health food producers on notice: to make any health claims, you’d better have RCTs to back them up.

Write to the FDA and tell them to protect free speech about the benefits of natural health products.

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Protect free speech about natural foods

Dear [Decision Maker],

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I was disappointed to read the recent guidance on substantiating structure/function claims for infant formula.

In the guidance, the FDA "recommends" that double-blind randomized controlled trials (RCTs) be used to substantiate structure/function claims on these products.

In other words, infant formula should be treated like drugs.

I am worried that this latest move has implications far beyond infant formula products, and will be applied to natural health foods and other products that many, many consumers rely on. The effect of this standard will be to deny consumers important information about these products and foods.

RCTs are incredibly expensive, and the FDA and FTC know full well that natural product companies--which by law cannot patent-protect their products--wouldn't be able to afford one, let alone two, RCTs. Additionally, RTCs are a terrible match for food (or supplement) research. A drug molecule can be better isolated in its effects than food can--but even with pharmaceuticals, interactions with other drugs are largely ignored, which leads to many deaths.

Foods and supplements are, by contrast, simply part of our diet, and how they are used by the body depends on co-factors. For example, supplemental calcium should not be taken without supplemental K2. Vitamin D is also important to getting calcium into your bones and not into your blood vessels. But isolating calcium for an RCT would miss all of that.

In addition, the effect of a food or supplement will depend on whether the subject is deficient in that nutrient in the first place. No one is nutritionally deficient in a drug.

I urge the FDA to abandon this RCT standard.

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