Natural Health Remedies | Health Blog

Off-label Drugs Get Free Pass from FDA


Off-label drug usage is based almost exclusively on anecdotal evidence – just like most herbs and neutraceuticals — except for the fact that the FDA allows physicians to promote such usage.

A bill before the New York State Assembly intends to force supplement manufacturers to add a warning label to their products indicating whether or not the product has been tested by the FDA. The bill states that, “no person shall manufacture, sell or expose for sale any product which shall be termed as a dietary supplement or nutritional supplement without branding or labeling such product with a statement which is clearly discernible to a customer that the product has or has not been tested by the United States Food and Drug Administration.” Understand, supplements already bear a label that says, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease,” so this new label will be in addition to that one.

Now here’s a case of ignorance compounding ignorance. (If the scenario applied to a bank account, the owner of that account would be reveling in accrued wealth.) Not only do the members of the New York Legislature seem to have a mindless and self-defeating vendetta against nutritional supplements, they also appear to be under the impression that the FDA actually tests nutritional products. What maroons!! Or as David Seckman, Executive Director of the Natural Products Association points out, “It doesn’t make any sense. FDA doesn’t test products.”

Seems that those who put that bill on the table better go and hide under it. That’s right — the Food and Drug Administration does NOT test products — not cosmetics, not food, not even pharmaceuticals, and certainly not supplements.

The testing of products falls to the manufacturer. The FDA, then, enforces such testing, inspects manufacturing plants, and sets testing guidelines, but again, it relies on the manufacturers to run their own clinical evaluations. Pharmaceutical companies are required by law to “test” their products. Supplement manufacturers, because they use ingredients that are generally regarded as safe by the FDA, are not. By law, supplement manufacturers fall into a different category than drug companies. They do not need to run their products through clinical trials before marketing them, as long as the products are manufactured and marketed in compliance with the Dietary Supplement Health and Education Act (DSHEA) and with manufacturing requirements put forth by the FDA that govern quality control, ingredient testing, plant construction, etc.

Obviously, the big snafu here is that the legislators, who are out to score political points, are absolutely clueless when it comes to understanding the law. Another disturbing fact, though, is that the New York Senate takes for granted that an FDA stamp of approval, if such a stamp actually existed, would mean a product is certifiably safe. In their dreams!!! If it were true, how do the legislators explain such debacles as the FDA approval of aspartame, which even the FDA admits causes brain tumors, mammary tumors, pancreatic tumors, ovarian tumors, pituitary adenomas, uterine tumors, and so on? How do they explain the fact that a panel of five leading experts who sat on the FDA’s own Drug Safety and Risk Management Advisory Committee admitted in a 2006 report published in The Archives of Internal Medicine that agency-mandated testing often misses serious problems with drugs and doesn’t adequately protect consumers?

How do they explain the fact that numerous drugs have been recalled from the market after FDA-mandated testing and approval (including, Seldane, PPA, Baycol, Rezulin, Trovan, Bextra, Propulsid, etc.) because they caused severe side effects and in many cases, deaths. For instance, the FDA approved the blood-thinner Heparin, which caused 81 deaths from contamination, and Vioxx was withdrawn from market in 2004 after demonstrating an increased incidence of heart attacks and strokes in long-term users. (The FDA now admits Vioxx may have caused as many as 139,000 heart attacks. Yeah, let’s hear it for FDA testing.) According to the New England Journal of Medicine, 14 percent of all pharmaceutical drugs that were rushed through the approval process within a few months of an approaching deadline turn out to have severe safety problems. That margin of error is huge.

Certainly, the FDA has kept some dangerous drugs off the shelves. But the point is, the FDA stamp of approval doesn’t mean a product is safe, and even more to the point, it doesn’t mean that it’s good for you (high-fructose corn syrup is an approved commodity, for instance). Trying to scare consumers into avoiding nutritional products with a label indicating that the FDA hasn’t “tested” them is just plain ignorant. It’s also dangerous…and highly predictable. Three years ago, when New York City instituted the first ban on trans fatty acids in city restaurants, many in the alternative health community celebrated. I did not. I clearly stated my belief that the trans fat ban was merely the nose of the camel getting inside the tent and that soon enough we would see the rest of the camel moving in with us. And now thanks to the bicameral buffoons of the New York State Assembly, we have.