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More than ever, American’s are purchasing over-the-counter (OTC) medications, supplements, and herbal remedies to self medicate and promote good health. But does the fact that these products can be purchased freely imply that they are absolutely safe for consumption? Do they go through the same FDA approval processes as other pharmaceutical products?

Generally speaking, for a new a new drug to sold in the US, its producer needs to submit a New Drug Application (NDA) to the FDA. Through the NDA, the producer presents studies that prove the safety and efficacy of the product. Once the FDA has approved the product, it can be sold to the general public, either as prescription-only or OTC, depending on the restrictions the FDA decides upon. The entire process is quite expensive for the drug producer. However, there are two ways in which a drug can enter the market without first acquiring FDA approval.

First, as a result of the Dietary Supplement Health and Education Act of 1994, manufacturers of supplements and botanical products are solely responsible for ensuring the safety of their products prior to market entry. There is no requirement for any studies on safety or efficacy to be conducted. And, should concerns regarding safety arise, the FDA is limited by the tremendous burden of proof required to regulate these products.

Ephedra, the Chinese herb containing the alkaloid stimulant ephedrine, exemplifies a botanical product that was able to circumvent the FDA’s NDA and approval process. Once sold in energy supplements and weight loss products, ephedrine was found by the FDA to “present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use” (FDA Ruling). The FDA could only attest to the lack of safety of ephedra after it had been on the market and caused many adverse reactions. And, even then, it took 10 years for the FDA to successfully remove it from the market.

Second, the FDA grants automatic approval to all of the substances contained in the Homeopathic Pharmacopoeia, which is authored by the non-governmental Homeopathic Pharmacopoeia Convention of the United States. Zinc gluconate, the primary ingredient of Zicam and a compound in the Homeopathic Pharmacopoeia, is marketed as a homeopathic cure for the common cold. And, since it is “offered for use in [a] self-limiting condition recognizable by consumers, [it] may be marketed OTC.” (FDA Compliance Policy Guide)

Literature suggests that zinc gluconate (at 33mM, the concentration used in Zicam) is ineffective at preventing the common cold (here is another study with similar results). And this is where complication begin to arise: if Zicam would have been required to submit an NDA, then its lack of efficacy alone would have kept Zicam off the market.

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But after 130 recent cases of anosmia, a temporary or permanent loss of smell, the FDA has issued a warning advising consumers to avoid using all three Zicam cold remedies. So, if Zicam poses even the slightest risk of anosmia and may elicit no more than a placebo effect, is it really worth using?

Botanical, supplement, and homeopathic products dodge the NDA requirement and are marketed under the guise of FDA approval. They imply to their consumers that the FDA acknowledges the safety and efficacy of their products. Automatic approval does not mean a product is safe and/or effective — it only means that congress created a loophole for manufacturers. Consumers need to realize this fact and exercise a greater degree of skepticism when dealing with these types of products.