How Do You Regulate Legalized Fiction?

How Do You Regulate Legalized Fiction?

n 1938 Congress passed the Food, Drugs and Cosmetics Act, part of which defines as a drug any product in the US Homeopathic Pharmacopoeia (HPUS). This designation was due to the Senator who sponsored the bill, Senator Royal Copeland, a homeopath.

As a result of the law, anything nostrum in the HPUS is considered legal. The only premarket approval for a homeopathic nostrum is finding its way into the HPUS, which does not require the standards of safety and efficacy that real medications have to meet.

As a result the FDA has failed at any form of regulation of homeopathic products.

As evidenced by the FDA guidance documents…the Court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs, and has instead attempted to delegate this authority to the non-governmental organization that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.

The FDA has tried and failed in the past, but are interested in regulation again:


“The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.”

Homeopathic products are legal and the FDA knows they are useless, a conclusion repeatedly supported by reviews of homeopathy.

While homeopathy is often used for relatively mild illnesses, it is also offered as treatment or prevention or diseases that can kill: asthma, malaria and meningitis.

It will be interesting to see what the FDA can do. Homeopathy is nothing that does nothing but a legalized nothing. Reading Conditions Under Which Homeopathic Drugs May be Marketed is kind of sad, the FDA being required to recognize the processes by which products are added to the HPUS such as provings. It is a sorry sight that an organization that usually is based on reality is forced by law to use fantasy.

It will take an act of Congress to remove the inappropriate and special designation of homeopathic nostrums. So it is unlikely that the FDA can remove homeopathy. Since the nostrums are intrinsically unable to have effect, they will also have no ill effects, the usual reason the FDA has to pull a supplement off the market. The danger from homeopathy comes from using the nostrums instead of real medications, which will make potential regulation interesting and challenging.

The FDA is asking for comments. Interested groups should participate.

Points of Interest 03/27/2015
Points of Interest 03/26/2015

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