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Would it be constitutional for a US state or the federal government to prohibit the sale of homeopathic "remedies"?

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    – Pat W.
    Feb 25 at 14:37

5 Answers 5

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Would it be legal for a US state or the federal government to prohibit the sale of homeopathic "remedies"?

Yes.

There are all sorts of medical treatments and drugs that are illegal. In general, Food and Drug Administration (FDA) approval is already required to sell drugs, and they impose a requirement that a drug be both safe, and more effective than a placebo. Homeopathic "remedies" are, by and large, safe, because they don't do much of anything, but are one of the treatments most scientifically well-established to be ineffective.

It probably wouldn't even require legislation for an FDA regulation to declare that anything labeled "homeopathic" (even without accompanying "remedy" language) is, by virtue of that label claiming to be an effective remedy, and to ban that. The barrier to doing so is political and not legal.

The U.S. Constitution does not afford you a legal right to use anything that you want as a drug.

There might be some opportunity for someone to try to claim a religious exemption, but that isn't an easy case to make, because homeopathic remedy advocates almost always claim a pseudo-scientific, rather than a religious basis for using them.

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    – Dale M
    Feb 26 at 0:06
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A state could not do this because of 21 USC 379(r) and other similar federal preemption laws. This subsection reads:

(a)In general Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—

(1)that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and

(2)that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

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The US Constitution says nothing about medications or supplements. Regulation is overseen by the federal department called the Food and Drug Administration (FDA), which was given authority by Congress in 1938 with the Federal Food, Drug, and Cosmetic Act to oversee food safety, drugs, medical devices, and cosmetics.

The FDA makes a legal distinction between drug and dietary supplement. A drug is allowed to claim its intent to "diagnose, treat, cure or prevent any disease" after a lengthy FDA drug approval process pharmaceutical companies go through. (In addition, many healthcare providers prescribe "off-label use", but that's a whole another topic.) In contrast, a dietary supplement can carry a "Structure/Function" claim that is substantiated by the manufacturer, and must include a disclaimer that the claims have not been evaluated by the FDA and the substance is not intended to "diagnose, treat, cure or prevent any disease". For more details, here is the text at the FDA website:

Dietary Supplements

Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread such a disease is in the United States. These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim. For more information about the difference between structure/function claims and disease claims, see 21 CFR 101.93, entitled "Certain Types of Statements for Dietary Supplements," and FDA’s January 6, 2000 final rule entitled "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body" (65 Fed. Reg. 1000).

Homeopathic products are detailed on an informational FDA page.

How are homeopathic products regulated?

Under the Federal Food, Drug, and Cosmetic Act, homeopathic products are subject to the same requirements related to approval, adulteration and misbranding as other drug products. There are currently no homeopathic products approved by FDA.

On December 6, 2022, FDA issued a final guidance, Homeopathic Drug Products, that describes the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. Since homeopathic drug products have not been approved by FDA for any use, they may not meet modern standards for safety, effectiveness, and quality.

This guidance proposes a comprehensive, risk-based enforcement approach to homeopathic products marketed without FDA approval.

FDA’s approach will prioritize regulatory and enforcement actions involving unapproved homeopathic products that pose the greatest risk to patients. Many homeopathic products fall outside the risk-based categories described in the guidance. FDA intends to focus its enforcement authorities on the following kinds of products:

  • with reported safety concerns;
  • that contain or purport to contain ingredients associated with potentially significant safety concerns;
  • for routes of administration other than oral or topical, e.g. for use as an injection or taken nasally;
  • that claim to treat or prevent serious and/or life-threatening diseases and conditions, such as cancer;
  • marketed to vulnerable populations, including children, pregnant women and the elderly; or
  • with significant quality issues.

In 1988, the FDA issued Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” which described the agency’s enforcement policy. On October 24, 2019, FDA withdrew CPG 400.400 because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement action.

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What do you mean by "Homeopathic Medications"? If you are asking if the actual substance then the answer is that it would not be legal because you would be making water illegal.

Homeopathy is a pseudo-science. The idea behind it it that water has a 'memory' for things it has encountered before. You dilute the bad substance with water and shake it up. You repeat until there is no actual amount of the bad substance left. There is no plausible method for it to work. Some German guy had an idea a couple of hundred years ago that this might work and started selling it.

There is no plausible scientific reason for it to work. Any homeopathic "medicine" you might take could be replaced with any other homeopathic "medicine" (or pure water) and have the same results. Just try to find an actual explanation of how the "medication" is prepared. The idea behind it is 'like treats like'. So if you get bitten by a rattlesnake, you take rattlesnake venom to cure you. But you dilute it.

The problem is that the normal dose is diluted to 1% 30 times. I think a good reason for math classes and how your high school math could be used in everyday life is to just think about that. If you dilute it that much, the resulting water would have 1/10e60 molecules from the original 'bad' substance.

That is an astounding number. Earth only has about 1.4e46 molecules of water. While you are almost guaranteed to have molecules of water that have passed through my bladder (and Hitler's, and every person and animal that has ever lived including dinosaurs), you probably don't have any molecules of the substance you were diluting. There is no mechanism put forward to account for any positive benefit from a harmful substance being diluted to the point of non-existence that doesn't account for everything else the water should 'remember' from where it's been before.

Given that, it is legal for the government to regulate claims of efficacy. While what you are getting, if the 'homeopathic medicine' is prepared correctly, is 'pure' water, the government can protect its citizens by preventing you from claiming that your water will cure disease.

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My understanding is that anything not addressed by the Constitution can be addressed by Federal, State and local jurisdictions. So if there is nothing in the Constitution that guarantees that a substance marked as homeopathic a homeopathic remedy can not be regulated, then the Federal, State, or local jurisdictions can pass laws to regulate them. Most OTC remedies are subject to the rules set forth by the FDA.

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    The 9th Amendment indicates that "The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.” reaganlibrary.gov/… Feb 24 at 14:27

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