Unsubstantiated health claims for COVID-19 infections are led by cannabidiol: return of snake oil medicine
Tóm tắt
The United States Food and Drug Administration (FDA) monitors, inspects, and enforces the promotion of products by companies that claim to mitigate, prevent, treat, diagnose, or cure COVID-19. The introduction of COVID-19-related diagnostics and therapeutics during the pandemic has highlighted the significance of rigorous clinical trials to ensure safety and efficacy of such interventions. The objective of this report is to provide a descriptive review of promotional violations of health products for COVID-19 infection. Warning letters issued by the FDA’s Center for Drug Evaluation and Research were retrieved over an 18 month period (March 6, 2020, to August 30, 2021) to identify promotional violations. FDA violation letters categorized as “Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)” were reviewed. A content analysis was performed for each letter to identify categories for product type, promotional venue, violation type, and country of origin. For cannabidiol-related violations, a content analysis was repeated within its own product category. A total of 130 letters were reported. Across all letters, cannabidiol products were the most frequent subject of violation (15/130; 11.5%). Of the cannabidiol letters, all reported the promotion of unapproved products (15/15; 100%), misbranding (15/15; 100%), and/or had claims that lacked scientific substantiation (14/15; 93.3%). All promotional violations were linked to websites (15/15; 100%), along with other mainstream venues: Facebook, Instagram, YouTube, Twitter, LinkedIn, and email. Lastly, the cannabidiol products were described to provide therapeutic benefit to COVID-19, by acting as an anti-viral (5; 33.3%), pro-inflammatory (1; 6.7%), anti-inflammatory (7; 46.7%), immune-booster (5; 40%), immune-suppressor (2; 13.3%), and/or other (2; 13.3%). Despite the urgent need for COVID-19 treatments, promotional material by companies must comply with standard regulatory requirements, namely substantiation of claims. As the pandemic persists, the FDA must continue their efforts to monitor, inspect, and enforce violative companies. Cannabidiol-related substances led the spectrum of products with unsubstantiated claims to treat COVID-19 infection. Improving awareness among the public, healthcare providers, and stakeholders highlights the value of drug approval process, while protecting public safety.
Tài liệu tham khảo
Bramstedt KA. Unicorn poo and blessed waters: COVID-19 quackery and FDA warning letters. Ther Innov Regul Sci. 2021;55(1):239–44. https://doi.org/10.1007/s43441-020-00224-1.
Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health. 2017;107(8):e1–e12. https://doi.org/10.2105/AJPH.2017.303818.
Jackler RK, Chay C, Brook D, et al. JUUL advertising over it first three years on the market. Standard: SRITA White Paper. Stanford School of Medicine; 2019. https://tobacco-img.stanford.edu/wp-content/uploads/2021/07/21231836/JUUL_Marketing_Stanford.pdf. Accessed August 28, 2021
Kinsella M, Fowler G, Boland J, Weiner DI. Trump administration abuses Thwart US pandemic response. In: Brennan Center for Justice. https://www.brennancenter.org/our-work/research-reports/trump-administration-abuses-thwart-us-pandemic-response. Accessed August 28; 2021.
Kuehn BM. Spike in poison control calls related to disinfectant exposures. JAMA. 2020;323(22):2240. https://doi.org/10.1001/jama.2020.8307.
Mayo MP. Hornswogglers, Fouflushers & Snake-Oil Salesman: True Tales of the Old West’s Sleaziest Swindlers. Guilford: TwoDot; 2015.
National Academies of Sciences, Engineering, and Medicine. Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda. The Health Effects of Cannabis and Cannabinoids. Washington, DC: The National Academies Press; 2017. https://doi.org/10.17226/24625.
Popp M, Stegemann M, Metzenford MI, Gould S, Kranke P, Meybohm P, et al. Ivermectin for preventing and treating COVID-19. Cochrane Database of Syst Rev. 2021. https://doi.org/10.1002/14651858.CD015017.pub2.
Sheikhan YN, Pinto A, Nowak D, et al. Compliance with cannabis act regulations regarding online promotion among Canadian commercial cannabis-licensed firms. JAMA Netw Open. 2021;4(7):e2116551. https://doi.org/10.1001/jamanetworkopen.2021.16551.
Snowden FM. Epidemics and society: from the black death to the present. New Haven: Yale University Press; 2019.
The New York Times. Health officials warn people not to treat COVID with a drug meant for livestock. New York: The New York Times; 2021. https://www.nytimes.com/2021/08/21/world/ivermectin-fda-covid-19-treatment.html. Accessed 30 Aug 2021
U.S Food & Drug Administration. Labeling Requirements – Misbranding. U.S Food & Drug Administration 2017. https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding
U.S Food & Drug Administration. FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns. U.S Food & Drug Administration 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details
U.S Food & Drug Administration. Beware of fradulent coronavirus tests, vaccines, and treatments. U.S Food & Drug Administration. 2021a. https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments
U.S Food & Drug Administration. FDA Regulation of cannabis and cannabis-derived products, including cannabidiol (CBD). Food & Drug Administration. 2021b. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#statesallowing
U.S Food & Drug Administration. FDA regulation of dietary supplement & conventional food products containing cannabis and cannabis-derived compounds. U.S Food & Drug Administration 2021c. https://www.fda.gov/media/131878/download
U.S Food & Drug Administration. Warning letters and notice of violation letter to pharmaceutical companies. https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/warning-letters-2020. Accessed Aug 28, 2021d.
Vidot DC, et al. The COVID-19 cannabis health study: results from an epidemiologic assessment of adults who use cannabis for medicinal reasons in the United States. J Addict Dis. 2021;29(1):26–36. https://doi.org/10.1080/10550887.2020.1811455.
Wagoner KG, Lazard AJ, Romero-Sandoval A, Reboussin BA. Health claims about cannabidiol products: a retrospective analysis of U.S Food and Drug Administration warning letters from 2015 to 2019. Cannabis Cannabinoid Res. 2021. https://doi.org/10.1089/can.2020.0166.
Weir A. Henry VIII: The king and his court. New York: Ballantine Books; 2002.
Witek TJ. Please don’t call it medical marijuana unless it is; but it probably isn’t. Can J Public Health. 2021;112(1):74–7. https://doi.org/10.17269/s41997-020-00333-2.
Witek TJ, Schwartz R. The cannabis conundrum. Look both ways before crossing a deserted road. Annals ATS. 2020;17(3):264–6. https://doi.org/10.1513/AnnalsATS.201908-581PS.
Zagrodney K, Sheikhan NY, Pinto AM, et al. Drug advertising violations: a longitudinal analysis of FDA enforcement letters from 2005-2019. Pharmaceut Med. 2021;35(1):31–8. https://doi.org/10.1007/s40290-020-00370-9.