NPA Urges Societies to Report Adverse Events
WASHINGTON, D.C. – A new policy announced by the American Medical Association ignores the superior safety record of nutritional supplements and extremely low adverse event rates as compared to other Food and Drug Administration (FDA) regulated products like pharmaceuticals and even conventional food. The new AMA policy also downplays the significant and proven health benefits of nutritional supplements as millions of Americans look for ways to support their immune systems and wellness during the COVID-19 pandemic.
“Nutritional supplements are strongly regulated in the United States and their safety record is far superior to prescription and over the counter drugs, and even conventional foods: we don’t have a Vitamin C crisis in America, we do have an opioid crisis,” said Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association. “Granted, there is no substitute for a healthy diet, exercise and good choices, and people should always speak to their doctor before deciding to take a supplement. But the truth is that few of us get enough nutrients from food alone and nutritional supplements are essential to millions of Americans who use them each and every day to support their health.”
Nutritional supplements play a critical role in supporting the health of millions of people in the United States and around the world, especially those who are from areas without adequate access to nutritious foods:
- Zinc deficiency can compromise immune function and increase the risk of infection, affecting an estimated 30% of the global population.
- A World Health Organization (WHO) report specifically showed benefits of zinc supplementation and immunity respiratory viruses in children.
- According to available data,95 percent of adults and 98 percent of teens have an inadequate vitamin D intake and 61 percent of adults and 90 percent of teens do not get enough magnesium.
- More than23 million Americans, including 6.5 million children, live in food deserts – areas that are more than a mile away from a supermarket.
The Natural Products Association (NPA) in a letter to medical societies including the AMA, urged healthcare providers to provide more detailed information for adverse events related to nutritional supplements. A more detailed account of these events will help policymakers and healthcare providers better understand how they occur.
“Adverse events from supplements are extremely low given their widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors,” said Dr. Fabricant.
Healthcare providers can report adverse events to manufacturers or FDA through the safety report portal. This system, the Center for Food Safety and Applied Nutrition (CFSAN)-Adverse Event Reporting System (or, CAERS) is the same system as MedWatch, which is FDA’s reporting program for FDA-regulated products. MedWatch (and CAERS) receives information from the public; when necessary, this information will inform safety alerts.
“We agree that the FDA can do a better job by using all of the enforcement tools it has available to protect consumers but regulating vitamin C like a drug isn’t the answer. Rather than opining about regulations and misleading Americans about the safety of nutritional supplements, the AMA would be better off urging its members to do a better job reporting adverse events associated with nutritional supplements,” said Dr. Fabricant.