The FDA caution against the potential risks of homeopathic products.
According to some estimates, a third of adults and more than 11% of children in the United States are using complementary health approaches.
In 2012, the Centers for Disease Control and Prevention (CDC) analyzed a sample of almost 89,000 adults.
They found that over 40,000 of these were taking “nonvitamin, nonmineral dietary supplements,” and that over 5,000 were using homeopathic treatments.
According to some sources, homeopathy is a $1.2 billion industry in the U.S. As more and more people start to purchase these products, the risk of unsafe products reaching consumers is also rising.
To prevent this, in 2017, the FDA issued a draft guidance document wherein they explained how they assess the risks of homeopathic products.
Now, they have revised this document and are asking the public for feedback and input on the new version.
The FDA are also withdrawing a previous compliance policy guide — entitled “Conditions Under Which Homeopathic Drugs May be Marketed” — which they issued in 1988, as the policy no longer reflects their current thinking.
Dr. Norman E. Sharpless, the acting commissioner of food and drugs, and Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research, authored the FDA statement that details these two new steps.
FDA urge public to review draft guidance
In their statement, the FDA explain the need for safeguarding the public from the potential risks of homeopathic products.
Homeopathic drugs, they say, “are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons.”
“These products have the potential to cause significant and even permanent harm if they are poorly manufactured,” they claim.
As part of the revision of the 2017 draft guidance, the FDA have now detailed which categories of homeopathic products pose a higher risk to public health, and which particular ingredients and methods of administration are less likely to be safe.
They are also planning to give details on “products for vulnerable populations, and products with significant quality issues.”
The FDA call for the public’s help in revising this draft before it is final. In their statement, they say, “We encourage the public to review this revised draft guidance and comment before it is finalized.”
“We will consider feedback gathered through this new public comment period, the more than 4,500 comments interested stakeholders submitted on the original 2017 draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic [drugs].”
The final version of the document will “provide transparency regarding the categories of homeopathic drug products that [the FDA] intend to prioritize.”
Withdrawing compliance policy guide
The FDA have also withdrawn their compliance policy guide (CPG) entitled “Conditions Under Which Homeopathic Drugs May be Marketed.”
The main reason for this withdrawal is that since issuing the CPG, the FDA have encountered several situations in which homeopathic drugs posed a significant risk to human health — even though the products, as labeled, appeared to meet the conditions described in the policy. The FDA write on their website:
“CPG 400.400 is inconsistent with our risk based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking. Therefore, it is appropriate to withdraw [it].”
These two steps are part of a larger effort to protect the public from potentially harmful homeopathic products.
As part of this effort, the FDA have issued over 10 warning letters to homeopathic drug producers, with recent recipients including Kadesh Inc., U.S. Continental Marketing Inc., Fill It Pack It Inc., and Bershtel Enterprises LLC dba WePackItAll.
According to the FDA, these companies have worked together to produce and package eye drops in nonsterile conditions, which could cause serious eye infections.
The FDA also encourage consumers and healthcare professionals alike to report any adverse health effects or problems with homeopathic products to their MedWatch Adverse Event Reporting program.