Botanical Drugs versus Botanical Dietary Supplements

Do you know the differences between botanical drugs from botanical dietary Supplements? Please read on even if you know the answer.

There are only two botanical drugs approved by FDA as of today. Last January, FDA approved Fulyzaq, the first anti-diarrheal drug for HIV/AIDS patients. Fulyzaq (crofelemer) is only the second botanical drug approved by FDA. The drug is made from the sap of the Croton lechleri plant. It is indicated for the treatment of watery diarrhea due to the secretion of electrolytes and water in the HIV/AIDS patients gastrointestinal tract. FDA reported that a recent clinical trial of 374 HIV-positive patients established the safety and efficacy of the drug. In the study, nearly 18 percent subjects taking Fulyzaq twice daily experienced clinical improvements.

FDA approved the first botanical prescription drug, Veregen, in 2006. VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in patients 18 years and older. It is formulated as an ointment.
Approval of this first botanical drug came about two years after FDA issued a guidance for the submission of a New Drug Application (NDA) in 2004. Prior to my retirement from FDA, I was a member of a Committee that drafted this guidance.

Two important distinctions between botanical drugs versus supplements are product claims and designated uses. In some cases the formulations of botanical drugs and botanical dietary supplements can be similar, but labeling has to be different.

Moreever, a botanical drug can claim to treat, prevent, cure, mitigate or diagnose a disease, but a supplement cannot. Therefore in order to become a botanical drug, the manufacturer/marketer must obtain pre-market approval from FDA by submitting an IND application, and then move on to the extensive NDA process to confirm safety and efficacy.
(http://theintellectualmigrant.blogspot.com/2011/11/simplified-overview-of-new-drug.html)

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical (excluding tobacco), an amino acid, a concentrate, metabolite, constituent, extract, or combination of any of the above or a substance historically used by humans to supplement the diet.

Furthermore, it must also conform to the following criteria: intended for ingestion in pill, capsule, tablet, powder or liquid form, not represented for use as a conventional food or as the sole item of a meal or diet, and labeled as a "dietary supplement"

Based on the Dietary Supplement Health And Education Act of 1994 (DSHEA), the Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, and not as drugs. Therefore, pharmaceutical companies are required to obtain FDA approval, which involves assessing the risks and benefits prior to their entry into the market, dietary supplements do not need to be pre-approved by FDA before they can enter the market. Thus approval of new botanical drugs is a slow and tedious process, whereas dietary supplements are freely available for the consumers.

In September 2012, a report said sales of herbal dietary supplements in the United States rose by 4.5 percent in 2011. That report estimated 2011's U.S. sales as US$5.3 billion, whereas sales of the two botanical drugs approved was poor and sluggish.

I hope more botanical drugs are approved by FDA in the future. Botanical drugs in general have less side effects compared to the synthetic drugs.