Homeopathy began in the 18^th century, based off of teachings from a German scientist, Samuel Hahnemann. The main concept in homeopathy is that, “like cures like” (similia similibus curentur) meaning that disease causing substances can also be used to cure those same diseases, if the substances are greatly diluted.

The FDA is considering whether homeopathic drugs should be treated like OTC drugs and undergo clinical trials to be proven safe and effective, as well as obtain approval for labeling. The new calls for regulation are in response to the current boom of the homeopathic industry in recent years. The last time that homeopathic drugs were examined by the FDA was in 1988. In 1988, homeopathic products were only a multimillion-dollar industry in the United States. According to the Center for Disease Control and Prevention, sales of homeopathic products reached nearly $3 billion in 2007. Due to the increased sales volume of homeopathic products and concern in recent years, the FDA believes that it now has more information to work with in order to make a decision.

Currently, homeopathic drugs are subject to various FDA administered laws and regulations. In particular, homeopathic drug manufacturers must also comply with certain FDA regulatory requirements, explained here in the compliance policy guide and explaining the conditions under which homeopathic drugs may be marketed. Further, manufacturers must also comply with the Food, Drug, and Cosmetic Act. Accordingly, industry advocates argue that the current regulatory scheme is more than adequate to ensure that consumers who choose homeopathic products receive safe and effective products.

Currently, the FDA is gathering information about homeopathic drugs in order to determine if they should be regulated like other over the counter medicines, like aspirin or decongestants and require approval for marketing. Because the state of laws and regulations applicable to homeopathic drugs may be changing very soon, any person or company in this industry should be on alert for changing requirements for their products. It is important to consult with an expert before any new policy comes into effect to ensure full compliance with new laws and regulations.

We offer comprehensive FDA compliance assistance, including label reviews and reviews of health claims to help our clients ensure that their products are in full compliance with FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.

Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of the afflicted are women.  The active ingredient in the Oxytol is called Oxybutynin, which belongs to a class of drugs known as anticholinergics.  It has the distinction of being the first drug from this class made available for over the counter treatment (“OTC”) for overactive bladder. 

When the original Federal Food, Drug and Cosmetic Act was enacted in 1938, there was no clear distinction between OTC drugs and prescription drugs. It was not until 1951, with the passage of the Durham-Humphrey amendments, that this issue was addressed and specific standards for classification of OTC drugs were created. The Durham-Humphrey amendments required that drugs that are not likely to be used safely without supervision from a doctor be dispensed by prescription only.  These prescription-only drugs were essentially deemed unsafe as they were believed to be habit-forming, toxic, have the pote

ntial for harmful side effects, or are for the treatment of maladies that cannot be diagnosed by a layman. The Durham-Humphrey amendments also provided that all other drugs that do not meet the criteria for unsafe drugs can be sold OTC.

The process of taking a drug from prescription to OTC status is called an “Rx to OTC switch.” This switch can happen in two ways, either by a manufacturer’s submission of additional information about the drug or by an “OTC drug review.” In 1972, OTC drug review began in order to review on an ongoing basis the safety and effectiveness of all drugs that are permitted for non-prescription use.  Through the OTC drug review process, experts in the field then will review the active ingredients to determine if they are indeed safe and effective. The second way a drug is approved for OTC use is through the new drug application process. Under this process, the manufacturer must submit information to the FDA that clearly shows the drug is appropriate for self-administration. Often, the information will include the submittal of studies showing that the product label can be easily read and understood by the consumer without the aid of a healthcare professional. More information about the Rx to OTC switch process may be accessed here.

If you have additional questions with Rx to OTC switch process or the FDA’s regulation of drugs, please contact us at contact@sglawfl.com.

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