Viking Blog – December 20, 2021
The United States has a long history of well-marketed panaceas, over-hyped health fads, and frightening curatives that, oftentimes, had worse effects than whatever condition they were intended to treat. Some of these ingredients could have great therapeutic benefits—in certain circumstances—but could also be quite dangerous when used in over-the-counter products. Others proved deleterious to health and were banned from inclusion in comestible products and cosmetics, or in some cases outlawed entirely. Lithium, better known today for its use as a treatment for some patients with Bipolar Disorder, was included in sodas and tonic waters, as were plant-derived stimulants such as cocaine and strychnine. Derivatives of the opium poppy, such as laudanum and morphine, found their way into cough medicines and sleep aids. Arsenic, mercury, and lead were each used as beauty aids and cosmetics. Radioactive elements had their heyday in the 1920s, when components such as radium were dissolved into beverages like RadiThor, with the promise of energy, mental acuity, and enhanced libido. Instead, they displaced calcium from bone tissue, resulting in gruesome damage to bones and teeth, damaged eyesight and blood cells, and led to cancer. While these cases from the past can seem both extreme and absurd from today's perspective, the fight to keep consumers safe is ongoing.
The process of establishing legal protections and guardrails surrounding food, drugs, and cosmetics in the US began in 1820 with the writing of the first United States Pharmacopoeia, a centralized list of standard, recognized drugs. As medicine and technology advanced, so did the need for consumer protection. A series of laws and Supreme Court rulings filled out the framework for the safe production, sale, and availability of food products, drugs, and cosmetics. 1848's Drug Importation Act tasked the US Customs Service with stopping shipments of tainted or poor-quality drugs from entering the country. From 1905 to 1955, the American Medical Association oversaw a voluntary vetting process that required drug companies to furnish proof that their drugs worked as claimed in order to be advertised in any of the AMA's medical journals. 1906 saw the passage of the original Food and Drug Act, which banned states from buying and selling food, beverages, and drugs that were adulterated or mislabeled. In 1911, the Supreme Court heard the case of United States v. Johnson, regarding how the existing law defined misbranding. The opinion of the court, as written and delivered by Justice Oliver Wendell Holmes, Jr., stated that mislabeling or misbranding:
"shall apply to all drugs or articles of food, . . . the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein, which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the state, territory, or country in which it is manufactured or produced. . . . An article shall also be deemed to be misbranded: In case of drugs: First. If it be an imitation of, or offered for sale under the name of, another article. Second. [In case of a substitution of contents] . . . or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances contained therein."
However, the Court determined that the law in its contemporary form did not specifically address labeling claims about any curative or therapeutic uses, only the contents of and/or identity of a product. Congress responded by passing the Sherley Amendment in 1912, which took a first step towards banning the use of fraudulent claims about a drug's effectiveness. However, its wording required that intent to defraud be proven: “The phrase "false and fraudulent" as used in the Sherley amendment to the Federal pure food and drugs act must be taken with its accepted legal meaning, and thus it must be found that the statement regarding the curative or therapeutic effect of the article was made with actual intent to deceive–an intent which may be derived from facts and circumstances, but which must be established."
Congress began a multi-year process of legislative wrangling in 1933, when the FDA recommended completely overhauling the 1906 Food and Drug Act. As is often the case, a tragedy was needed to push lawmakers past procedural arm wrestling and to take real action. The S.E. Massingill Company released a formulation of Sulfanilamide, a powerful but bitter antibiotic. The drug was solubilized using diethylene glycol, which gave the elixir a sweet, palatable taste. Unfortunately, diethylene glycol (commonly used today in antifreeze solutions and brake fluid,) when ingested, quickly becomes absorbed through the gastrointestinal tract and reaches the liver, spleen, brain, and kidneys, as well as being stored in adipose (fat) tissue. It is metabolized into two main compounds, HEAA (2-hydroxyethoxyacetic acid) and DGA (diglycolic acid), and can cause severe damage to all affected organ systems, including renal failure, hepatitis, pancreatitis, neurological damage, coma, and death. 107 patients who received Massengill's Elixir of Sulfanilamide, died rather horribly.
This unfortunate catalyst resulted in the passage of the Federal Food, Drug, and Cosmetic Act of 1938. New provisions in the law expanded protections to cover cosmetics and therapeutic devices, eliminated the proof of intent to defraud in misbranding cases from the Sherley Amendment, required safe maximum tolerances for poisonous components whose use could not be avoided, and required that new drugs be shown to be safe before they could be sold or marketed.
The Durham-Humphrey Amendment was added in 1951 to account for and define drugs that were restricted to prescription status by a licensed medical practitioner, versus those that were available over-the-counter to any consumer. The 1962 Kefauver-Harris Amendments fortified the safeguards before a drug company could bring a product to market, requiring more thorough drug trials conducted with informed consent, and raising the bar on proof of any medical claims.
Although the United States has come a long way in terms of protecting patients and consumers, it is most definitely an ongoing battle/high stakes game of Whac-A-Mole. Consider the litany of fake COVID cures, including, famously, the colloidal silver liquids and lozenges sold and promoted by Sherrill Sellman with the help of televangelist Jim Bakker in the early months of 2020. On a February 12 broadcast, Bakker referred to the emerging coronavirus pandemic as “this influenza that is now circling the globe,” and Sellman claimed that the “Silver Solution,” “[had] been proven by the government that it has the ability to kill every pathogen it has ever been tested on, including SARS and HIV.” No such proof exist, yet she continued to make such claims on her podcast, websites, and social media pages. Bakker was sued by the Missouri Attorney General and has been ordered to desist in his claims and sales of the product, as well as to pay restitution to viewers of his program who sent money to him in exchange of the fake COVID cure. The FDA and the Federal Trade Commission issued a warning letter to Dr. Sellman on June 1, 2020, after finding her products and claims to be in violation of multiple sections the Federal Food, Drug, and Cosmetic Act, including misbranding of drugs, making unsupported claims about their use and efficacy, and violating interstate commerce rules.
Yet, the FDA has issued almost 200 such warning letters between March 6, 2020 and September 28, 2021 solely for fraud related to coronavirus claims, and more than 1200 warning letters for overall fraud, misbranding, and sale of unapproved drugs. While the march of time and science have certainly made things safer for the consumer, it is still very important to be cognizant of potential risks and fraud. As each regulation is written into law, charlatans and money-hungry opportunists seem to find ways to skirt the edges and push counterfeit products and dangerous misinformation.