The Current and Future Regulation of Dietary Supplements
Americans have it good when it comes to access to dietary supplements, too good, some would argue. In comparison to most other industrialized countries, there are virtually no restrictions on the type or strength of nutritional supplements which can be purchased in the United States. The only significant limitation on the sale of supplements is that disease and cure related claims cannot be made by supplement manufactures without FDA approval. And the FDA has approved very, very few disease related claims for supplements. (Even Saw Palmetto, which is fairly widely recommended by urologists for Benign Prostrate Disease cannot carry such a claim.)
The situation is much worse in the rest of the world, and especially in Europe. Many European countries have adopted the highly restrictive CODEX standards for dietary supplements. CODEX standards all but eliminate the consumer’s ability to purchase dietary supplements in therapeutic or meaningful preventive dosages. The net effect of CODEX is that useful dietary supplements will be as hard to get as prescription drugs in many European countries. In fact, it might be a lot harder to obtain real dietary supplements in Europe because CODEX will likely squash the demand and cause manufacturers to simply withdraw from these unprofitable markets.
There has been much written and debated during the last few years about whether CODEX is coming to the United States (see for example my slide presentation to the 2005 IAACN conference listed in the “Publication” page in this website), but as long as key members of Congress continue to support the consumer’s broad right of access to these products, we should be safe from a direct application of CODEX to supplements in the United States.
That does not mean that dietary supplements will not receive increased federal regulatory attention. They have, and will continue to do so.
In December 2006, Congress passed and President Bush signed the “Dietary Supplement and Nonprescription Drug Consumer Protection Act.” This bill was sponsored by Senate supplement supporters like Tom Harkin and Oren Hatch, as well as anti-supplement Senators Dick Durbin and Ted Kennedy. On the House side, Henry Waxman was, as usual, a main driving force behind the legislation. The bill requires dietary supplement manufacturers to put on the label a telephone number for consumers to report a “serious adverse event.”
Although many in the supplement industry predicted grave consequences if the bill passed, I believe it will have no impact on consumes and little impact on the supplement industry, when it takes effect in 2008.
Only a “serious adverse event” needs to be reported. That means basically death or a life threatening experience, which normally would require hospitalization and/or medical or surgical intervention to prevent death or a life threatening experience. With a few highly publicized exceptions (Ephreda, and an illegally genetically altered batch of Tryptophan), generally speaking, dietary supplements do not cause life threatening experiences. Therefore, it seems unlikely that there will be large numbers of “serious adverse event” reports flooding manufacturers.
Second, only the manufacturer (or by agreement with the manufacturer, a distributor of a privately labeled supplement) has the responsibility make the “serious adverse event” report. Retailers and other providers of supplements, such as health care practitioners have no reporting requirement. Therefore, I do not see that this new law will have much of an impact on consumers or the dietary supplement industry.
But of course, this might not be the last dietary supplement bill promulgated by the new Democratic Congress. Based on direct personal contacts, I believe that some of the key Democratic legislators knowledgeable about the issue think there is too much access to, what they feel are supplements of unproven value. More restrictive legislation may be in the works. However, I have found some of the key legislators to be reasonably fair and open-minded.
I would also expect continued efforts by the FDA in its rulemaking capacity to attempt to increase its role of overseeing or regulating dietary supplements. In addition, since Europe and much of the rest of the industrialized world is adopting CODEX, the FDA and their some of the more extreme supporters might be further emboldened to propose more restrictive legislation or rulemaking.
Therefore, I would expect that the dietary supplement industry and the consumers which it services will face continuing challenges and increased regulatory pressure. I think the key to positive legislative and administrative progess will be to find a proper balance between protecting consumer choice and protecting the consumer from harm; a difficult, but not impossible task.