It Depends On What You Mean

As we move further into our advocacy work and again more momentum, we often receive emails with questions. Recently, we received a really great question from one of our supporters. After our President, Paola Brown, wrote her response, she realized that many of our supporters may benefit from this information. So, for this week’s blog post, we decided to share her letter with you.

Dear Homeopathic Supporter,

Thank you so much for your concern about homeopathy. It is such an important system of medicine to us, and our access to it is critical.

Our organization is called Americans for Homeopathy Choice (AFHC).  As mothers who use homeopathy to care for their families, we came together in response to the FDA’s first Draft Guidance on homeopathy issued in December 2017. I’m writing to clarify a few things you touched on in your email so that you will have an understanding of our position on the FDA’s Draft Guidance.

First, you are technically correct in saying that FDA is not “ruling” that homeopathy is illegal. That is because FDA Guidances are not legally binding documents. They are, however, statements of FDA policy about how the agency will enforce the law. So it’s important to highlight that FDA is saying that it will treat homeopathic remedies as “illegal” for enforcement purposes.

The FDA has been very clear in its written statements and also to us during our in-person meetings with FDA senior officials that the agency intends to treat homeopathic drugs as “illegal” for enforcement purposes. This means that the FDA can take any homeopathic drug off the market without notice or formal prior review.

We steadfastly dispute that the FDA has the legal authority to treat homeopathy as illegal.

Just to be clear about what the FDA has written, let me quote from the revised Draft Guidance issued in October 2019 which simply repeats language found in the December 2017 Draft Guidance (now withdrawn):

Accordingly, absent a determination that a homeopathic drug product is not a “new drug” under section 201(p), all homeopathic drug products are subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act. There are currently no homeopathic drug products that are approved by FDA. (Underline added for emphasis. FD&C Act refers to the Food, Drug & Cosmetic Act of 1938 and its amendments.)

What the FDA is stating is that it believes there is no determination in the law, in agency proceedings or in court rulings that homeopathic drugs are NOT “new drugs” and that therefore the agency will henceforth treat them as “new drugs.”

We again dispute the agency’s position. We believe there is ample evidence in the record of FDA statements and findings over the years and in the FD&C Act and its amendments that demonstrate that homeopathic drugs are, in fact, NOT “new drugs” under the law.

The FDA’s new interpretation of the law, however, is embedded in the proposed Draft Guidance which outlines how the FDA will enforce the law. So, here is the second important piece of text from the Draft Guidance which demonstrates why we are saying that the FDA will treat all homeopathic drugs as illegal:

In the listing that follows, we clarify our general approach to prioritizing our enforcement and regulatory actions with regard to homeopathic drug products marketed in the United States without the required FDA approval. However, this guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time. (Underline added for emphasis.)

By following the FDA’s language closely, we can see that the agency has explicitly declared that it will treat all homeopathic drugs on the market today as “illegal” and therefore “subject to FDA enforcement action” under the proposed Draft Guidance.

The agency states the following:

  1. All homeopathic drugs are subject to premarket approval.
  2. There are currently no homeopathic drug products that are approved by the FDA.
  3. Any homeopathic drug product that is being marketed illegally is subject to FDA enforcement actions at any time.

Since “all homeopathic drugs are subject to premarket approval”—that  is, they are subject to going through the New Drug Application process—and no homeopathic drugs have gone through this process, all homeopathic drugs being marketed in the United States today are being “marketed illegally” which makes them “subject to FDA enforcement action.”

The Draft Guidance does not make an exception for properly manufactured and labeled homeopathic medicines—which are the safest category of drug the FDA regulates because they are nontoxic by definition. In fact, the FDA recently commenced enforcement action against properly manufactured and labeled injectable homeopathic medicines and means to force them out of the marketplace, not because they pose a danger to anyone—they are, after all, nontoxic and administered by a licensed physician—but because according to the FDA they are being “marketed illegally” since they are “new drugs” which have not gone through premarket approval, that is, through the New Drug Application process. Thousands of patients face the possible loss of medicines with an impeccable track record in supporting their health.

Not only that, but the FDA’s recent actions now confirm that the agency intends to take enforcement actions against many inherently safe, nontoxic homeopathy medicines that are properly manufactured and labeled instead of focusing on the real problem which is products claiming to be homeopathic that don’t meet homeopathic standards for quality, purity and/or dilution.

The FDA will say that its interpretations of the FD&C Act and the Act’s amendments in the Draft Guidance are not legally binding. But, I would say, “Ask the owners of the company whose injectable homeopathic medicines have been seized and impounded at the border by FDA enforcement personnel whether the Draft Guidance is ‘legally binding.’” Again, I would say, “Ask the patients who are suffering because they are being denied medicines which they have relied on for years to alleviate that suffering whether the Draft Guidance is ‘legally binding.’”

We should note that the Draft Guidance is still under review and has not been adopted by the agency, so we find it curious that the agency is taking action as if the guidance has been adopted.

The consequences that both manufacturers and patients are suffering are those which legally binding actions would, in fact, inflict. The FDA is being challenged in court over the seizure of injectable homeopathic medicines at the border. It seems from where we sit that these are, in fact, serious legal matters.

FDA senior staff members have confirmed in meetings with us that they intend to treat homeopathic drugs as “illegal” for enforcement purposes.  They have confirmed that they believe they have the authority to take any homeopathic drug off the market with no notice or hearing of any kind. Any assurances they make that the “majority” of homeopathic medicines will be unaffected fly in the face of the plain language of the Draft Guidance which makes no exceptions. And, it is little comfort to those who will lose access to the homeopathic medicines they need if the “majority” of medicines that the FDA refers to does NOT include the medicine or medicines they depend on to maintain their health.

To understand our concern about New Drug Applications, I would suggest reading this 2019 Policy & Medicine article on the cost of drug development. It states:

Developing a new prescription medicine that gains marketing approval is estimated to cost drugmakers $2.6 billion…. This is up from $802 million in 2003—equal to approximately $1 billion in 2013 dollars, and thus a 145 percent increase in the ten year study gap.

The New Drug Application system is designed to address the safety problems of chemical pharmaceuticals which are toxic by their very nature. By contrast, homeopathic medicines from the inception of the FD&C Act in 1938 have been exempted from the NDA process by the FDA precisely because homeopathic medicines are nontoxic.

In 2017 the agency abruptly, without cause and without any prior notice to homeopathic drug makers or users revised its position in an informal announcement. It is our argument that homeopathic remedies are old drugs and are not subject to the NDA process which was designed for the chemically toxic and inherently dangerous “new drugs”.

We argue that the FD&C Act of 1938 explicitly recognizes homeopathic medicines as a class of drugs which are inherently safe (and distinct from chemical pharmaceuticals). The law also recognizes that homeopathic drugs are subject to the provisions of the Homeopathic Pharmacopeia of the United States, through which they are evaluated for safety and efficacy—not the NDA process.

Chemical pharmaceuticals, however, due to their inherent lack of safety, are required by law to demonstrate that their benefits outweigh their risks before they can be marketed as drugs.

AFHC will continue to engage the FDA and members of Congress until we have secured long-term protection for the full range of homeopathic medicines that people depend on to maintain their health.

Because the FDA’s policy and actions pose such a large threat to homeopathy, our organization, AFHC, has submitted two Citizen Petitions. The FDA denied our first petition. But in connection with that petition, the agency withdrew the 2017 Draft Guidance and offered a revised Draft Guidance in 2019. This revision was released the same day our first petition was denied. While the revised 2019 Draft Guidance was a slight improvement—it included a definition of homeopathy, something which had been absent in the 2017 document—AFHC continues to be concerned about FDA’s position that they intend to treat homeopathic drugs as “new drugs.”

Please know that on June 5, 2020, we filed our second Citizen Petition with FDA under the APA.

It may be helpful to read and review our information about that petition: https://homeopathychoice.org/fdacomment/  Please feel free to ask us any further questions you might have about our petition, our legal and legislative activities and our educational campaigns about homeopathy.

We believe strongly that homeopathy is a very important option for consumers seeking health choices for themselves and their families. We believe that the law guarantees access to this choice. And, we believe that the FDA’s policies and enforcement actions are unfortunate and misguided and will limit consumer access to inherently safe, nontoxic homeopathic drugs—a key health option for American consumers.

Thank you so much for your concern about homeopathy, and please do let us know if you have further questions.  We would love to engage in a dialogue if you are so inclined.

Paola

Paola Brown, President

Americans for Homeopathy Choice

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