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FDA Toughens Enforcement of Homeopathic Products

FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people.

First, the Agency has withdrawn Compliance Policy Guide (CPG) Sec. 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” The CPG was issued in 1988 and described an enforcement policy that permitted unapproved homeopathic drugs to be marketed if certain conditions related to labeling, ingredients, manufacturing, and other considerations were met. In withdrawing the CPG, the Agency observed that products that seemed to meet the criteria described in the CPG nonetheless caused or could have caused serious harm. 

Second, the Agency has revised its draft guidance entitled “Drug Products Labeled as Homeopathic.” The revised draft guidance describes enforcement priorities for homeopathic drugs marketed without required approval. According to the revised draft guidance, these priorities include:

•Products with reports of injury that, after evaluation, raise potential safety concerns.  For example, MedWatch reports on other information submitted to the Agency can indicate or signal a potential association between the product and an adverse event, medication errors, or other safety issues.

•Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised by products that contain or purport to contain:

– An infectious agent with the potential to be pathogenic;

– A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 812;

– Multiple ingredients that, when used in combination, could result in possible interactions, synergistic effects, or additive effects of the various ingredients; and,

– Ingredients that pose a risk of toxic, or other adverse effects, particularly when the ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process.

  • Products 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 or conditions. . . .

  • Products for vulnerable populations. . . .

  • Products with significant quality issues. . . .

The revised draft guidance stresses that “nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements.” It further emphasizes that “any homeopathic drug product that is being marketed illegally is subject to FDA enforcement at any time.”

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Eleanor (Miki) A. Kolton, Greenberg Traurig Law Firm, Washington DC, Healthcare and Cybersecurity Law Attorney
Of Counsel

Eleanor (Miki) A. Kolton has wide-ranging legal, administrative and management experience in medical practice law; HIPAA, Stark, Medicare and CMS regulations; with the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); and other civil and administrative law areas. She possesses executive corporate experience and broad clinical background in a variety of health care settings, including the ability to understand scientific and medical community cultures, business challenges and concerns.

Prior to joining the firm, Miki...

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Justin Prochnow, Greenberg Traurig Law Firm, Denver, Healthcare and Litigation Law Attorney
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Justin J. Prochnow assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries. Justin works closely with companies to ensure regulatory compliance with statutes and regulations enforced by the Food and Drug Administration, the Federal Trade Commission and other regulatory agencies. This includes the review of product labels, labeling, advertising, websites and other marketing materials. Justin assists companies with responding to governmental and regulatory actions, including FDA inspections and warning letters, FTC Civil Investigative Demands, and ASRC and NAD cases. He prepares and reviews business documents for industry members, including consulting, manufacturing, supply and distribution agreements. Justin and his team also defend industry companies from both governmental agencies and civil litigators in litigation ranging from breach of contract cases to the growing number of class actions alleging false and misleading advertising.

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Christopher Health Care & FDA Practice Greenberg Traurig's Houston
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Christopher M. Koepke is a member of the Health Care & FDA Practice in Greenberg Traurig's Houston office.

Christopher has diverse and deep experience at the intersection of legal, scientific, and policy issues. Prior to joining the firm, Christopher served as regulatory counsel in the U.S. Food and Drug Administration (FDA) Office of Regulatory Policy, where he focused on policy development across numerous aspects of the FDA’s regulation of drugs and biologics. He also participated in responding to citizen petitions touching a broad array of topics. In addition, Christopher...

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