In December of 2017, The Federal Drug Administration issued a Draft Guidance proposing that the guidelines governing the manufacture and sale of homeopathic remedies in the United States for the last thirty years be withdrawn and replaced by an updated version.
The process began two years earlier when the FDA initiated a review of the regulatory structure of homeopathic products. The reasons given were that the current guidelines had not been updated since they were put in place in 1988, that the market for homeopathic remedies had considerably in that time, and that allegedly there safety concerns regarding their manufacture and sale.
At that time, there was a public hearing to determine the need for clarification of the current guidelines. The homeopathic community responded by voicing general approval of them as they had served the profession and consumers well, but also made recommendations about how they could be upgraded.
Those recommendations were ignored in the 2017 proposal and instead wishes to put in place guidelines that would give the FDA the arbitrary power to ban a considerable portion of the remedies currently available.
In 1988, the FDA in conjunction with the American Association of Homeopathic Pharmacists formulated the current guidelines, known as the Compliance Policy Guide 400.400. It has been by all accounts a great success providing clear direction to the industry to make and sell homeopathic products. It also formed the basis by which substandard or mislabeled products were eliminated.
The background to the formulation of CPG 400.400 is the following:
"For many years (from 1938-1988) homeopathic drugs were sold in a regulatory vacuum. FDA action was based on institutional understanding and informal agreements between agency officials and industry members. This caused the FDA to regulate in an unpredictable manner that made the homeopathic industry unsafe from a regulatory and investment standpoint; and the practice of homeopathy open to the whims of local regulators. During the period, the FDA viewed all homeopathic remedies as prescription drugs. From 1982-1988, the industry, professional and consumer members of the community through the American Homeopathic Pharmacists Association (AHPhA) worked with the FDA in the development of a regulatory framework called a Compliance Policy Guide (CPG). Although the community didn't get every provision that it sought, it is argued that the community obtained about 80% of its requests. The new CPG strengthened the definition of the homeopathic drug, set forth guidelines for the prescription and nonprescription drugs and made clear packaging and labeling guidelines. "1
Since the safety record of homeopathic remedies has been excellent over the last 3 decades, the question that arises is what exactly is the goal of revising CPG 400.400? Is there a subtext involved in fixing a mechanism that isn't broken?
The FDA states that the new proposed guidelines will prioritize enforcement actions against homeopathic remedies containing the following2:
1. Infectious agents with the potential to be pathogenic.
2. Controlled substances, that is, drugs for which one must get a doctor’s prescription.
3. Multiple ingredients that, when used in combination, raise safety concerns due to possible interactions, synergistic effects, or additive effects of the various ingredients.
4. Ingredients that pose potential toxic effects, particularly when those ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process.
But in point of fact, a correctly labeled homeopathic remedy is neither pathogenic nor could it be consider a controlled substance (though it could derive from such a substance). And, CPG 400.400 already provides the FDA authority to take appropriate action in regard to mislabeled products.
Furthermore, there are no known dangers associated with 'combination remedies' - those that include more than one ingredient - as long as taken appropriately. This is no different than any over the counter pharmaceutical product.
A clearer picture of the real motivation behind instituting new guidelines can be found in the proposal to give the FDA authority to ban a particular homeopathic remedy because such remedies “may cause users to delay or discontinue medical treatments [using pharmaceuticals] that have been found safe and effective.”
Put simply, the FDA is concerned that too many people are using homeopathy as their first line of treatment and avoiding having to resort to pharmaceutical products. Given the efficacy, safety and affordability of homeopathic remedies in contrast to the dangers and cost associated with the use of many pharmaceutical drugs, this would seem like a good thing... unless you were in or influenced by the business of selling pharmaceuticals.
The homeopathic community has been encouraging those interested in preserving access to remedies to take advantage of the comment period on the FDA Draft Guidance. Interested persons need to act immediately as the window for comments closes on December 1st.
Specific information can be found at: https://www.homeopathycenter.org/fda-comment-period-extended-0
Also, people can support a petition drawn up by Americans for Homeopathy Choice (https://homeopathychoice.org/petition/) asking the FDA to:
1. Form an FDA advisory committee on homeopathy.
2. Withdraw the Draft Guidance on Drug Products Labeled as Homeopathic dated December 2017 which threatens to severely restrict the availability of homeopathic remedies..
3. Convert Compliance Policy Guidance 400.400 (with minor changes) into a regulation. This is the policy that has guided the agency since 1988 and resulted in high standards of quality assurance in the manufacture of homeopathic remedies even as choice and availability continues to grow.