Patent medicines during Prohibition

I’ve recently learned that patent medicines, which usually contained a lot of alcohol, somehow were exempt from Prohibition. In specific, one called Dr. Kilmer’s Swamp Root, which was made in Binghamton NY, seems to have been produced thoughout Prohibition, even though it had a 7% alcohol content. I get the impression it wasn’t the only one. Surely the FDA didn’t approve of these kinds of quack medicines. So how were they able to to do this?

If I recall, alcohol was permitted for both medical and religious (like Catholic Mass) purposes.

The story of Jamaica Ginger and “Jake Leg” provide a insight into the time-

(Quick Summary: A high Alcohol Patent medicine adds an adulterant to fool the Government dissolved solids test, said adulterant turns out to be a neurotoxin)

My impression is that while there was a crackdown on truly dangerous patent medicines (including those loaded with booze and opiates) as a result of the 1906 Pure Food and Drug Act, proof of efficacy was not a high priority during Prohibition days (and indeed, it is not mandated now).

A 7% alcohol content for a patent medicine wasn’t much compared to Lydia Pinkham’s (an “herbal” medicine for female complaints), which during Prohibition was available (according to Wikipedia) in a 40 proof strength, likely accounting for much of its popularity.*

And lots of docs wrote prescriptions during Prohibition for “medicinal liquor” (Scotch etc.) to treat conditions ranging from “debility” to “La Grippe”.

*Lydia Pinkham’s is still sold today, though the alcohol content isn’t what it was back in the 1920s-30s.

Even after Prohibition ended pharmacy alcohol remained popular. Pharmacists could sell straight ethanol or liquor as a medicine in addition to the patent medicines and they were in demand in ‘dry’ locations and jurisdictions where alcohol sales were banned on Sunday.

I assume somewhere along the way regulations reduced the alcohol content of OTC medications and prescriptions would be required for anything with a high alcohol content. OTOH I doubt anyone is checking on the distribution of ethanol as medicine as they do with class 1 drugs.

The courts had ruled that in order to prove fraud the FDA had to prove that the intent of the manufacturer was to defraud the public. So if the manufacturer thought they were efficacious they were not engaged in fraud.

Looking online, Lydia Pinkhams started out around 18% and is now about 9% and for what they charge for it these days, an alcoholic/underage/someone that can’t legally have booze is probably better off buying mouthwash. But during prohibition, I’m guessing 18% for not much money, it was probably well worth it. It was probably their sizzurp. Legal, from a doctor and didn’t risk blowing anyone up in the shed.

Might’ve been safer than a lot of the rotgut available during prohibition since it could be made with legally distilled ethanol.

Fernet Branca was a legal medicine in California (or all of U.S.?) throughout the Depression, probably a big factor in SF’s love for the stuff.

From 1906 they could watch for adulterated or mislabeled or putrid goods. It wasn’t until 1938 that they could screen for safety and not until 1962 that they could require proof of efficacy. At least according to Wikipedia.

"The (Dietary Supplement Health and Education Act of 1994) established that dietary supplements are a category of food and therefore are regulated as such—not as drugs. This means that manufacturers do not need to prove that dietary supplements are safe and effective before they can market them.’