FDA Regulation of Homeopathic Remedies

Take the liver and heart of a Barbary duck and allow it to sit at room temperature for 40 days until it liquefies. Next, dilute the liquefied goo at the ratio of one part goo to 100 parts water. Continue diluting at the same ratio. After 12 such dilutions, there will be no more molecules of duck goo remaining. For good measure, dilute 188 more times for a total of 200 dilutions. Next is the genius part. Package your last dilution in a box with the description of “Anas Barbariae Hepatis et Cordis Extractum” (Latin is impressive) and sell it as Oscillococcinum – “Nature’s #1 Flu Medicine.” Look for it on the shelf at CVS or Walgreens – it’s really there, along with a slew of other homeopathic “medicines.”

Proponents of homeopathy maintain this all makes sense since the “active” ingredient (duck goo) “imprints” its antiviral power on the water. Is it safe and effective? Well, it’s certainly safe since there’s nothing in it. Effective? It’s at least as effective as water. Nevertheless, it sits on the shelf and I suspect people assume the FDA has verified its efficacy. Therein lies the rub. The FDA does not test or approve any homeopathic remedies. Instead, the Food, Drugs and Cosmetics Act of 1938 defines as a drug any product found in the US Homeopathic Pharmacopoeia (HPUS). The barrier for entry into the HPUS is very, very low.

The good news is that the FDA is holding a hearing and seeking comments to determine if it should change this policy and subject homeopathic nostrums to an approval process that demonstrates their safety and efficacy. I suspect it will be quite an uphill battle as big money comes out to fight against being required to show their products actually do what they say they do. The other barrier are the loyal fans of homeopathic medicines that don’t care to be encumbered by any scientific evidence because they “just know it works for me.”

The link below offers a rather complete discussion of the FDA hearing and its context. It’s an interesting read.




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