More threads by David Baxter PhD

David Baxter PhD

Late Founder
Natural Treatments For Psychiatric Conditions Are Unregulated
Monday, 3 April 2006

Hundreds of "natural" treatments are marketed for psychiatric conditions but are essentially unregulated by the FDA, according to the April issue of The Carlat Psychiatry Report.

According to a review conducted by The Carlat Psychiatry Report, hundreds of natural treatments are currently marketed for psychiatric disorders in the United States, an industry that is largely unregulated by the FDA.

While the FDA strictly regulates conventional psychiatric pharmaceuticals, such as Prozac and Ritalin, "natural" treatments (compounds that are not created in a laboratory) fall under the special category of "dietary supplements." In 1994, Congress passed a little-known law called DSHEA that drastically scaled back the FDA's authority over dietary supplements.

The result has been that hundreds of products have been introduced over the last decade for treating psychiatric problems without undergoing the review process required of standard medications.

An example cited by the newsletter is a product called "Brain Focus," produced by Z-labs and marketed on their Web site ( Brain Focus is a blend of 17 vitamins and herbals, none of which have been proven to be effective for any psychiatric disorder in large placebo-controlled studies. Nonetheless, it is advertised as "clinically tested to improve memory and focus." Such a claim is legal because it does not mention a specific psychiatric disease.

According to current government regulations, as long as a label doesn't say that a supplement actually cures a specific disease, positive health claims are allowed under a category known as "Nutritional Support Statements."

According to The Carlat Psychiatry Report: "If asked to, manufacturers are required to produce some sort of 'substantiation' for their claims. However, unlike the FDA approval process, evidence need not be based on placebo-controlled double-blind trials; case series, small open trials or even suggestive animal trials are sufficient."

The Report concludes by recommending that psychiatrists and patients scrutinize the claims on supplement labels: "We recommend that psychiatrists ask their patients whether they are taking dietary supplements and find out what is in them. Many patients will be surprised to learn that the health claims on the labels often are based on tiny unreplicated studies. They may then decide that there are better ways to spend their hard-earned money."

The Carlat Psychiatry Report is edited by Daniel Carlat, M.D., an assistant clinical professor of psychiatry at Tufts University School of Medicine in Boston, MA.

The full text of the article can be found at The Carlat
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