LIFE SCIENCES CLIENT ALERT: FDA Issues Proposed Enforcement Policy Regarding Homeopathic Drugs
Marking a potentially dramatic new direction, on December 18, 2017, the U.S. Food and Drug Administration (“FDA”) issued a press release and Draft Guidance announcing a new proposed enforcement policy regarding homeopathic drugs. If finalized, the new enforcement policy would change the existing compliance policy focusing on labeling requirements which has been in effect for about 30 years. The changes come about a year after the FDA found homeopathic teething products containing belladonna did not accurately state the actual amount of belladonna in the products and after some teething products were allegedly linked to reported injuries and deaths in children.
As stated by the FDA in its Draft Guidance, homeopathy is an alternative medical practice first recognized in the late 1700s. Homeopathy is generally based on two main principles: (1) that a substance which causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses; and (2) the more diluted the substance, the more potent it is. The FDA states that proponents of such drugs claim that a significantly diluted aqueous solution, consisting mainly of water molecules, retains therapeutic properties due to a “memory” of the substance diluted in it. The FDA further states that historically homeopathic drugs have been identified through “provings,” in which substances are administered to healthy volunteers in concentrations that provoke overt symptoms. Symptoms experienced by volunteers are recorded to indicate possible therapeutic uses for the substances. The FDA states that in homeopathic practice if a substance elicits a particular symptom, individuals experiencing that symptom would be treated with a diluted solution made from that substance.
Citing the increase in the use and mass marketing of homeopathic drugs in recent years, the FDA states that it intends to use a risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. The FDA has identified six (6) types of homeopathic drugs which it believes have the greatest potential to cause risk to patients. Homeopathic drugs which do not fall under these categories are not subject to the new guidance. The six areas are the following:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- products recommended for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- products for vulnerable populations; and
- products that do not meet standards of quality, strength or purity as required under the law.
The FDA specifically noted and singled out as examples of drugs subject to enforcement being infant and children’s products containing belladonna and nux vomica (e.g. strychnine); and products marketed for “serious conditions,” such as cancer and heart disease.
We will continue to monitor this issue and will advise of any developments, including when the Guidance is finalized.
Disclaimer: This update is intended to educate generally on certain issues and is not intended to provide legal or professional advice. The information and opinions expressed in this document are solely those of the authors and do not necessarily represent the views or opinions of any current or former clients of Segal McCambridge Singer & Mahoney, Ltd.
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