OTC and RX Drugs

Before a botanical product is marketed as a drug with a claim to diagnose, treat, cure, or prevent a disease, it must first be approved by the FDA. The revision of the Food, Drug, and Cosmetic Act in 1962 required all drugs marketed after that time to be proven both safe and effective.

This revision presented the FDA with the challenge of updating its approval of hundreds of drugs already on the market that had not been proven effective. The FDA set up panels of experts to review the active ingredients of these drugs, many of which were sold over-the-counter.

However, many herbal products were found to be either unsafe, ineffective, or simply lacking sufficient evidence to evaluate (Tyler, 1993). In order to obtain drug status for a new botanical product, or for one that failed a previous evaluation, manufacturers must submit a New Drug Application (NDA) to the FDA.

This requirement holds whether the new drug is to be sold as an OTC or Rx drug. The NDA must contain evidence of the product’s safety and efficacy. This evidence is usually in the form of pharmacological studies, ranging in scope from in vitro assays and small animal studies to randomized, double-blinded clinical trials in humans, with an emphasis on the clinical studies.

The benefit to pharmaceutical firms which manufacture synthetic chemical drugs is that their research is rewarded by patent protection for a substantial period of time. However, as most herbs have previously been marketed in a traditional form, and thus are not new or unique, they are not eligible for patent protection.

There are some exceptions when a botanical is prepared in a unique form (for example, the ginkgo extract EGb 761) or for a previously unknown use. Without patent protection, most manufacturers are unwilling to spend the money necessary to conduct the research required for a new drug application.

In addition, manufacturers may find it easier to forego scientific studies as they can easily sell their products as dietary supplements. The Commission on Dietary Supplement Labels (1997) recommended that the FDA establish a “review panel for OTC claims for botanical products that are proposed by manufacturers for drug uses” (p. 57).

However, in April 1998 the FDA published a notice responding to the commission report, indicating that the agency considers such a review to be “premature” at this time. The FDA did not give an explanation for their decision (FDA Notice, 1998).

Petitions formally requesting that valerian and ginger be recognized as old OTC drug ingredients were filed with the FDA in 1994. Nearly six years later, the agency issued a response provisionally accepting the supporting data, which was largely European, but only under very stringent conditions.

Valerian and ginger have yet to become OTC drugs. Numerous experts agree that a select number of botanicals are proper candidates for OTC drug status.

Although this would mean that some plant extracts would be available both as dietary supplements and OTC drugs, it is likely that many American consumers who currently would not use a certain herb as a dietary supplement would accept and use that same herb if it were offered as a drug that has received FDA (government) approval.

Likewise, physicians, pharmacists, and other health care providers would be far more inclined to recommend, or at least not discourage, the use of an herba OTC drug. The reasons being that OTC drugs are manufactured under stricter good manufacturing practices, and OTC products have mandatory labeling which includes dosage recommendations, cautions, and warnings.

Although manufacturers of botanical products are welcome to submit their products for review under the new drug approval process, it does not appear that the FDA is prepared to actively welcome OTC applications for botanicals as old drug ingredients.

That is, for a botanical to achieve OTC status, it must have all the scientific research required for a new drug. It is unlikely to be “grandfathered in” as an old drug without that documentation.