FDS Intensifies the Pressure on the Manufacturers of Homeopathic Drugs in the United States

The FDA announced that it had issued 5 warning letters to companies that manufactured and marketed homeopathic drugs for human use. This occurred on the 14th of May. Four of the letters were issued to the four companies which jointly manufacture and package homeopathic eye drops that are indicated for post eye surgery use. (eg cataracts or glaucoma). The fifth letter was sent to a manufacturer of human drugs that are labeled as homeopathic remedies for serious diseases such as blood poisoning, liver problems, chicken pox, measles, mumps, suicidal tendencies, pediatric vaccination complications and other things.

The 11 warning letters are in order with the FDA’s revised guidance and enforcement policy for human homeopathic drugs, announced in the draft form on the 18th of December 2017 which included the following risk-based enforcement priorities:

  • Products that report safety concerns
  • Products that include ingredients associated with potential safety concerns
  • Products that have a route of administration other than oral or tropical
  • Products that mare meant to be used for prevention or treatment of serious/life threatening diseases or conditions
  • Products that are intended for vulnerable populations
  • Products that do not meet standards of quality, strength or purity as set by the law.

As the revised enforcement policy is intended to supersede the existing homeopathic drug compliance policy from 1988 however, the FDA has not finalized the revised policy yet. The proposed draft guidance garnered about 3,250 comments after the period for comments was extended to the 21st of May 2018. It is likely taking the FDA a lot of time to review and consider these comments in proposing a final version of the policies. Despite this, the FDA appears to have adopted the revised policy and carries out enforcement actions that are relevant to it. The increased activity this year could indicate that the FDA is getting closer to finalizing the revised enforcement policies yet it may be too soon to tell.