By Karen Kier
Pharmacist on behalf of the ONU HealthWise team
"Be safe" is part of the Urban Dictionary as a statement of farewell. The Urban Dictionary is an online source started in 1999 to help us understand slang words and phrases. "Be safe" is a way to say goodbye and to stay out of trouble, especially with the law.
In his 1906 novel The Jungle, author Upton Sinclair warned of adulterated and unsanitary practices in the meat industry. The uproar about food impurities prompted Congress to pass the Pure Food and Drug Act of 1906. The act passed the United States House of Representatives with a vote of 240 for and 17 against. President Theodore Roosevelt signed the legislation on June 30, 1906. The act required drugs to meet purity standards, as well as be labeled with the active ingredients.
Prior to Sinclair’s novel, several journalists and politicians were trying to curb the drug and food industries, which were selling potions with no labeling or purity standards. In the 19th century, traveling salesmen sold potions called snake oil. There were no laws to regulate ingredients or labeling. Baby teething compounds contained opium and alcohol.
This reminded me of the Mayberry RFD episode when Aunt Bee is charmed into buying a miracle elixir from a traveling salesman. As the show goes on, Andy guesses the elixir is repackaged alcohol and Aunt Bee and her church friends are getting drunk on the potion. As sheriff, Andy arrests the ladies and puts them in Mayberry’s jail to sober up. Although this situation was a comedy, the purity of medications is no laughing matter.
One would think with the passage of the 1906 act with the recognition of the United States Pharmacopeia setting purity standards for drugs that we would not have anything to worry about. Then, the 1937 deaths of 105 patients who consumed an elixir of sulfanilamide prepared with the toxic diethylene glycol identified the flaws in the 1906 legislation. The 1938 Federal Food, Drug and Cosmetic Act was passed to allow the Food and Drug Administration to regulate new drugs being introduced to the market especially related to safety. In 1962, Congress passed the Kefauver-Harris amendment to the 1938 law to improve FDA oversight of new drugs to include evidence of efficacy along with safety.
Why the history lesson? There is a danger on our shelves, which is not regulated by any of these laws. Exempt products not included in these laws include supplements and natural products. Many erroneously believe the safety and purity of some of these products. Evidence has been around for years, but some recent studies confirm the danger of the mislabeling.
The FDA does try to warn healthcare professionals and consumers when there is a danger with drugs and supplements. However, supplements are not required to register with the FDA and many products are being sold without any regulation to quality or safety. The FDA site can be found at www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements.
Melatonin is an example of a supplement with documented increases in toxic cases especially in children. Melatonin is used to help with sleep and jet lag. Melatonin use in children has increased 530% since 2012. The product comes in various forms for children including gummy and chewable formulations. Data published in Morbidity and Mortality Weekly Reports showed high-dose melatonin in children can cause serious consequences. The report indicated in 2021 that 287 children required intensive care treatment with 5 needing mechanical ventilation from excessive melatonin doses. The report determined high-dose melatonin resulted in the death of 2 children.
A study published in the Journal of Sleep Medicine evaluated 30 different over the counter melatonin supplements found on consumer shelves. The study compared the amount of melatonin indicated on the label to the actual amount when analyzed in the lab. The products ranged from having 83% less melatonin than reported on the label to 478% above the labeled amount. If that is not disturbing enough, twenty-six percent of the samples had other drugs included with the melatonin that were not declared on the label.
A study was published in the Journal of the American Medical Association to evaluate CBD (cannabinoid) products. The researchers tested 105 products with 45 available from retail stores and 60 purchased online. Of the 89 products listing CBD on the label, 18% contained more CBD than labeled and 58% had less CBD. Only 24% of the products were labeled correctly. The study evaluated the THC (active ingredient in marijuana) content of the products. Sixty-two percent contained THC that either indicated the product was THC-free or did not declare THC on the label.
The Dietary Supplement Listing Act of 2022 was introduced in the Senate on April 26, 2022 to improve the transparency of supplements and to require them to register with the FDA. This would be an amendment to the Food, Drug and Cosmetic Act. The bill is endorsed by the American Medical Association and the US Pharmacopeia. Currently, the bill is stalled in a Senate committee.
Talk to your healthcare professionals to get more information on the safety of supplements.
Be safe!
ONU HealthWise is offering COVID-19 vaccines, as well as flu shots Monday through Friday from 10 AM to 5 PM. The bivalent COVID-19 vaccines are available. Clinics are Monday-Friday from 4:00-6:00 p.m. Please call the pharmacy for more information.
ONU HealthWise Pharmacy
419-772-3784
www.onuhealthwisepharmacy.com
