Every so often the FDA does or says something so biased against the dietary supplement industry that it is difficult to understand how we are supposed to consider ourselves as working together in any form of real partnership. The Annals of Internal Medicine recently published an article (Annals.org 20 Aug 2019) entitled Swallowing Problems and Dietary Supplements: Data From U.S. Food and drug Administration Adverse Event Reports, 2006-2015. All of the authors are from either the FDA Office in College Park Maryland or the Center For Disease Control in Atlanta, GA. The objective of the article was stated as ‘identifying and characterizing dietary supplement associated swallowing problems in relation to pill size’ by using 10 years of data from adverse event reports submitted to the FDA Center for Food Safety and Applied Nutrition and Adverse Event Reporting System. The background for the article states that FDA has provided voluntary guidance to pharma regarding the size of generic drug tablets and capsules. The FDA recommends that capsules or tablets should not exceed 17mm and must not exceed 22mm. “Currently”, the authors note, “similar guidelines do not exist for dietary supplements; however, these products have been implicated in swallowing problems, particularly among adults aged 65 years and older.”
Other important points from this report to pay attention:
- 6% of the reported swallowing problems involved females.
- Of the 64.5% of the reports that included age data, 76.8% of the reported swallowing problems involved adults 65 years or older.
- Ten dietary supplements accounted for 76.4% of swallowing problems and involved products with a mean pill length, width and height of 19.3mm, 9.8mm, 7.8mm respectively, all measurements in excess of the FDA guidelines for generic drugs.
- The incidence for reporting of swallowing complications was 12.7 times higher with the mean measurements reported above.
- Seven of the ten products accounting for 64.5% of all swallowing problems were multivitamins marketed to older adults.
- A single multivitamin product marketed to older women was involved in 40.6% of all the swallowing problem reports.
This brief research report implies that because the FDA regulates and guides the prescription market the problem of choking is not relevant. A 2016 report on Emergency Department visits for outpatient adverse drug events contradicts this implication. Moreover as reported in Injury Facts 2017, choking is the fourth leading cause of unintentional injury and over 56% of people who died from choking in 2015 were older than 74.
With that said, there are some key learnings from this report that the dietary supplement industry as responsible industry leaders should take into account. Primarily, the size guidelines set forth by the FDA for the generic drug industry listed above could and should be applied to supplements. Here are some simple safety takeaways the dietary supplement industry can easily implement to improve the safety profile of the products.
- Follow the guideline of keeping capsules or tablets below 17mm in length.
- Special consideration in this regard should be taken into consideration when marketing to the elderly and/or females.
- Alternative delivery formats (i.e., gummies, chews, liquid) may also combat swallowability issues
In total, despite author bias and focus, this report serves as a wake-up call for our industry. We have an opportunity to reinforce the overall safety profile of dietary supplements in comparison to pharmaceutical adverse events by taking the steps above.
Punzalan C, Budnitz DS, Chirtel SJ, Geller AI, Jones OE, Mozersky RP, et al. Swallowing Problems and Dietary Supplements: Data From U.S. Food and Drug Administration Adverse Event Reports, 2006–2015. Ann Intern Med. [Epub ahead of print 20 August 2019] doi: 10.7326/M19-0947
Andrew I. Geller, M.D., Nadine Shehab, Pharm.D., M.P.H., Nina J. Weidle, et al. Emergency Department Visits for Adverse Events Related to Dietary Supplements N Engl J Med 2015; 373:1531-1540 DOI: 10.1056/NEJMsa1504267
Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. JAMA. 2016;316(20):2115–2125. doi:10.1001/jama.2016.16201