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This article was co-authored with Paul Hsieh, M.D., co-founder of Freedom and Individual Rights in Medicine.
"You can't have that. It's not good for you."
We've all heard parents say that to their children at the grocery store checkout line countless times. While it may be appropriate for a mother to say to her 10-year-old, it's simply the wrong way to treat adults. Yet that would be the effect of new restrictions on dietary supplements proposed by Sen. Richard Durbin (D.-Ill.).
Durbin's innocuous-sounding Dietary Supplement Labeling Act (S 1310) is a reaction to scandal surrounding Lazy Cakes—cupcakes with added melatonin to help adults fight insomnia. Some adults who purchased the cakes allowed toddlers in their care to consume them, and those children subsequently became ill.
Manufacturers are already required to disclose any unusual ingredients in products such as brownies that parents otherwise reasonably expect to be safe for children. The company that manufactured Lazy Cakes, now sold as the Lazy Larry, has now started clearly labeling its products "For Adults Only."
Durbin's bill would go far beyond requiring manufacturers to add warning labels to any supplements the Food and Drug Administration (FDA) deems potentially dangerous. It would force most, if not all, supplement makers to submit proofs of safety for their products to the FDA. While supplements must comply with the FDA’s “Good Manufacturing Practices” to ensure that the products contain what they say and are not contaminated, the FDA does not currently evaluate supplements for efficacy. This new proposal would require manufacturers to submit evidence of each ingredient’s safety. The change would thus raise the costs of many supplements—and force others completely off the shelves—jeopardizing the thriving dietary supplement industry.
Currently, Americans enjoy the freedom to walk into any drugstore and purchase inexpensive dietary supplements that can help with conditions such as arthritis, digestive problems or vitamin deficiencies. Many health-conscious Baby Boomers preserve and protect their health through careful use of such supplements. The proposed law would interfere with their right to purchase these products for their best medical interests.
The law would decrease choice and innovation in the dietary supplements market by raising production costs for supplements. It also would favor larger manufacturers able to afford the expensive FDA approval process, while restricting competition from smaller manufacturers without such deep pockets.
Durbin's proposal would also limit consumer choice in another, more subtle, way. In a classic example of Fredric Bastiat's principle contrasting "that which is seen and that which is not seen,” politicians and journalists routinely criticize the FDA for approving prescription drugs that subsequently cause unanticipated harm, but rarely acknowledge the suffering endured by patients who could have benefited—but did not—from products denied FDA approval. The FDA thus has a powerful political incentive to err on the side of denying approval for pharmaceuticals. Durbin's proposal would extend that incentive to many dietary supplements.
By restricting the choice and availability of supplements, the FDA would reduce consumers' ability to find products that work best for them on an individual basis. Due to natural biological variation, individuals can respond differently to different supplements intended to help with, say, insomnia or indigestion. One person may respond well to supplement A but not supplement B, whereas another may experience the opposite effect. Consumers thus benefit when they have the widest possible range of supplements to choose from.
The Durbin bill would infringe on the freedom on millions of ordinary Americans to act in their best medical interests. The government should respect the freedom of manufacturers to sell, and of consumers to purchase, dietary supplements according to their best judgment, as long as there is no fraud or misrepresentation. American consumers are grown adults capable of deciding what's best for their own health. Congress and the FDA should treat them as such.