On July 9, the Archives of Internal Medicine published the commentary, “The Consequences of Ineffective Regulation of Dietary Supplements” by Donald Marcus, MD, from Baylor College of Medicine in Texas and Arthur Grollman, MD, from Stony Brook University in New York.
Drs Marcus and Grollman conclude: “The consequences of DSHEA [the Dietary Supplement Health and Education Act of 1994] for consumers include the expenditure of tens of billions of dollars annually on ineffective and potentially dangerous dietary supplements.”
The commentary also calls for internists to strongly support the controversial draft guidance for new dietary ingredients (NDI), and “they should urge Congress to revise DSHEA to give the FDA the authority required to effectively regulate dietary supplements”.
To read the commentary, please click here.
In response to the commentary, Cara Welch, PhD, senior VP of scientific and regulatory affairs for the NPA said: “The commentary gets it wrong about dietary supplement regulation and may needlessly scare people into not taking products they use to support their health.
“It’s been long established that supplements provide nutrients we sometimes miss in our regular diet. Before taking any supplements, the Natural Products Association advises Americans to discuss supplement usage with their healthcare provider.”
“It’s important to note that supplements are a fully-regulated industry under the Dietary Supplement Health and Education Act. We’ve said it before and we’ll say it again. The Food and Drug Administration has all the authority it needs to regulate supplements under DSHEA. And the FDA agrees. Their officials have testified before Congress that they have all the tools they need to effectively regulate supplements.”
Enforcement, not more regulations
Welch continued: “The FDA regulates the safety, manufacturing and labeling of supplements, while the Federal Trade Commission has the primary duty of regulating supplement advertising. The FDA and the FTC have the authority to regulate company websites and take action against companies that step out of line.
“Instead of more regulations, NPA believes the supplement industry needs enforcement of existing regulations. We have time and again called on Congress to provide the resources needed to fully enforce the law.”
“The commentary relies on an old Office of Inspector General report from 2001 to produce an inappropriate estimate for the supposed number of annual adverse event reports. In fact, current AER data shows that supplements have an excellent safety record considering the volume of supplements sold annually to the tens of millions of Americans who take them.
“Furthermore, studies have found that supplement usage could save billions in health care costs through a lower incidence of sickness and ailments.”
The commentary also hit on the subject of adulteration, a topic that NPA shares concern about, said Welch. “These illegal products are not supplements and we support continued government efforts to crack down on those who make illegal drugs marketed as supplements,” she said.