Regulators Setting Crosshairs on Unproven Homeopathic Products

December 19, 2017

By Noel Courage

Homeopathic products are a growing industry. As more products hit the market, and their popularity increases, regulators in the United States and Canada are being asked to help better protect the public.   

Homeopathic Medicines in the United States

The U.S. Food and Drug Administration (FDA) is going to be ramping up its enforcement practices for homeopathic products. Draft guidance was released on December 18, 2017 for industry comment (90 days). The guidance is the product of FDA public consultations with the public. 

Homeopathy is based on the theory that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people[1].

The products that are unproven and have the greatest potential to cause risk to patients will be first in the hot seat for enforcement action. The FDA is taking this approach where, homeopathic treatments are being promoted for serious diseases and conditions, such as cancer or heart disease, but have not been shown to have clinical benefits. The purpose of this action is to protect seriously ill members of the public from spending money on therapies that are not clinically helpful. In some cases, people may have such misplaced trust in homeopathic products that they forego conventional medical therapies. The FDA is also intending to address products that contain potentially harmful ingredients are not manufactured in accordance with good manufacturing practices. This is a different issue than lack of clinical efficacy, since such products may themselves harm a patient. An example is products containing belladonna, which have been used to treat infant teething pain but were allegedly toxic and harmed children.  

Under the FDA’s former policies since 1988, homeopathic products have been manufactured and distributed without FDA approval.

The FDA stated in a press release that it intends to focus its enforcement on the following kinds of products:

  • products with reported safety concerns;
  • products that contain or claim to contain ingredients associated with potentially significant safety concerns (eg. Infectious agents, controlled substances, toxic ingredients);
  • products for routes of administration other than oral and topical (eg. injectable products);
  • products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions (eg. cancer);
  • products for vulnerable populations (eg. infants, elderly, immunocompromised patients); and
  • products that do not meet standards of quality, strength or purity as required under the law.

Many homeopathic products should fall outside the risk-based categories described in the new draft guidance and will remain available to consumers.

The U.S. Federal Trade Commission (FTC) is also requiring homeopathic product marketing claims to be supported by competent and reliable scientific evidence for health claims. Efficacy and safety claims will be held to the same standard as other drug products making similar claims. The FTC also stated its policy view that, “Homeopathic theories are not accepted by most modern medical experts.” 

Homeopathic Medicines in Canada

Across the border in Canada, homeopathic medicines must be licensed prior to being sold. The Canadian Natural Health Products Regulations set out the rulebook for these products. There are specific quality requirements for the ingredients used in homeopathic medicines. While evidence is supposed to be required prior to product approval and licensing, there has been media criticism that products were being licensed without scientific evidence to back up the claims on their labels. One media investigation found that government enforcement was, “difficult to spot on drugstore shelves.”

The US and Canadian governments are talking about improving enforcement against unsupported health claims and other issues with homeopathic products. In the meantime, it still appears to be the Wild West for consumers. 

[1] Federal Trade Commission. “FTC Issues Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs.”  November 15, 2016.  Accessed December 19, 2017. 

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