Posts Tagged ‘ Homeopathic ’

Put the FDA in Charge of Homeopathic Products

December 3rd, 2009. By Hunter West

The Zicam issue brings to the fore yet another issue involving the mandate of the US Food and Drug Administration (FDA), the federal health regulator that has jurisdiction over medical devices and medical drugs—and food. A wieldy mandate indeed and one that, due to funding and staffing issues, the agency has been hard-pressed to undertake effectively. 

That said, naturopathic products, natural-health potions and homeopathic elixirs do not fall under the FDA’s regulatory mandate for approval. 

Given the growing popularity of homeopathic products, the FDA’s mandate should be expanded. 

“Many of our clients believed the FDA had evaluated Zicam before it reached the market,” said lawyer Robert Gordon, a partner with the New York law firm Weitz & Luxenberg. “In fact, Zicam products were not regulated or approved by the FDA because they were listed as homeopathic treatments that use natural ingredients. Mounting evidence from the scientific community is proving Zicam with zinc should never have been sold. Some trusting users are now paying a price with their health.”

The status quo only confuses the public. To be fair, nowhere on the labels for products such as Zicam does it say that the product carries FDA approval. And yet, when there is a problem with a product—homeopathic or otherwise—which agency undertakes the issue of the health alert?

The FDA. The latter is also involved in the negotiation and co-ordination of voluntary product recalls—as it was for Zicam—for products the FDA was not required to approve. That, together with the blurring of the lines between what is medicinal and what isn’t, leaves Joe Q. Public at a loss to explain just who is running the show.

The same holds true for dietary supplements and other weight-loss remedies that use natural ingredients. If it’s homeopathic, then a product does not have to satisfy the FDA before it goes to market.

But here’s the rub: various medicinal ingredients, either on their own or in concert with other ingredients, can elicit side effects and other dangerous risks. Hence the requisite testing required of the manufacturers, with the subsequent vetting through the FDA before the product is approved for sale.

However, just because an ingredient is listed as ‘natural’—a mineral, herb or otherwise—doesn’t automatically suggest it is safe. Natural products can hurt you too, if used in the wrong way and in misguided combination with either another product or in association with an incorrect indication.

People who have used Zicam nasal spray for colds have reported a loss of their sense of smell. Sometimes it is immediate. For others the loss occurred after prolonged use. Some had their sense of smell return after they stopped using Zicam. Others are fearing that their smell loss (and concurrent loss of the ability to taste food) may be permanent, and lawsuits have been launched.

All, because of zinc. Zinc on its own has a benefit to the human body. It’s actually integral, in proper balance with copper, to maintaining a healthy system. However, zinc up the nose is apparently a problem, as various studies and a flood of reports to the FDA now show.

Would this have happened, had this product been required to go through the rigorous FDA approval process?

The FDA is under the gun due to the perception of lax oversight. The agency’s critics cite too many close ties, funding and otherwise, with pharmaceutical companies that only serves to cloud its objectivity. Defenders of the FDA cite the fact that the agency has suffered through years of chronic under-funding and staff shortages and thus cannot hope to cope with a regulatory environment that now sees drugs and medical devices increasingly manufactured offshore.

And now this.

The FDA needs to promote to the American consumer that it does not have jurisdiction over homeopathic products—at least at the approval stage—and therefore the consumer cannot assume that a homeopathic product he is buying comes with the FDA stamp of approval.

Either that, or Congress needs to provide a massive funding and staffing boost to the FDA in order to undertake its current mandate, together with the adoption of a new mandate to regulate the homeopathic industry.

The FDHA—the US Food, Drug and Homeopathic Agency.

Has a nice ring to it.  

Tags: FDA, Homeopathic, Zicam
Posted in Drugs/Medical, Emerging Issues | 9 Comments »