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In Focus: The "miracle health cures" that didn't pan out and when government regulation began

A long history of problematic medicine and peddling scams led to agency regulations in use today
Posted: 4:30 PM, Sep 21, 2021
Updated: 2021-09-21 18:26:06-04
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BALTIMORE — It can be hard to decipher health claims and when a product works as advertised.

Dr. Lydia Kang, a Baltimore native, wrote a book called "Quackery" detailing fake 'miracle' cures that have duped desperate people for hundreds of years.

"The book is full of, of examples in history, where we did all sorts of treatments that were just terrible, they did not work. And they were in many cases, very, very harmful." says Kang. "Things like strychnine, and mercury and arsenic that, you know, we thought were good for us were actually really horrible."

In England, in the 17th century, one popular, yet expensive remedy was called Mumia - made of ground up Egyptian mummies.

Kang described how scammers would try to profit, in gruesome detail, "And there was a lot of stuff going on with people, hawking fake mummy, so they would take sometimes dead bodies that were not Egyptian, and they would sort of dry it up and ground it up. And they would be like, 'Hey, I have some fake Mumia.'"

She added, "It was like kind of a similar thing, where people are just trying to fake out the consumer for the sake of making money."

In the United States, the Food and Drug Administration didn't start regulating imported drugs until 1848 and domestically produced drugs until 1906.

According to its website, the original Food and Drug Act was signed into law by President Teddy Roosevelt in 1906 before the agency was called the FDA.

Meanwhile, the Federal Trade Commission didn't open its doors until 1915 where it was tasked with protecting consumers from unfair business practices.

The two agencies now work together to protect consumers from products that fraudulently claim to have some health benefit.

In just the last few months, the FTC has sued a PPE marketer "for falsely promising quick delivery of N95 face masks"; has settled a case against Dr. Stephen Meis, who was accused of making "bogus health claims" for a COVID-19 treatment plan in which he has to pay more than $100,000 in refunds; and sent cease and desist demands to 10 companies suspected of making diabetes treatment claims without the required scientific evidence.

The FTC says that it "files a complaint when it has 'reason to believe' that the named defendants are violating or are about to violate the law and it appears to the commission that a proceeding is in the public interest."

But what exactly does the FDA regulate?

The Food, Drug and Cosmetics Act defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."

Another law, passed in 1994, details how the FDA is expected to regulate 'dietary supplements.'

The Dietary Supplement Health and Education Act of 1994 contains this long definition for 'dietary supplements':

“(ff) The term “dietary supplement” -
“(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
“(A) a vitamin;
“(B) a mineral;
“(C) an herb or other botanical;
“(D) an amino acid;
“(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
“(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
“(2) means a product that -
“(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or
“(ii) complies with section 411(c)(1)(B)(ii);
“(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
“(C) is labeled as a dietary supplement; and
“(3) does -
“(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and
“(B) not include -
“(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
“(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,
which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.
NIH

The Act also creates the Office of Dietary Supplements, tasked with studying the effects of supplements.

The FDA also has an Office of Unapproved Drugs and Labeling Compliance to, among other things, "identify and address fraudulent and dangerous drugs."

"As long as there were those gaps in our knowledge and gaps in care, people are going to fill them in with trying to find their own their own answers," said Kang.

If you suspect a fraudulent health claim, or have had an adverse side effect to a dietary supplement, both the FDA and the FTC have forms on their websites to submit complaints and to look up current recalls and notices.

Click here to file a complaint with the FDA.

And report fraud to the FTC by clicking here.