New FDA Rule on Dietary Supplements Will Not Alleviate Consumer Confusion
Statement of Bruce Silverglade, Director of Legal Affairs, Center for Science In the Public Interest
“The FDA’s new regulation on supplement claims will make it difficult for consumers to distinguish between beneficial and worthless products.
The FDA regulation allows companies to make claims about conditions associated with heart disease, cancer, memory loss, pregnancy and other serious health matters without any pre-market review by the agency. As a result, the marketplace may be flooded with thousands of deceptively labeled nostrums.
Under the new regulation consumers of the 21st century will have to follow the same adage as consumers of the 19th century — “Buyer Beware.”
The FDA’s new regulation creates hairsplitting distinctions between claims that require FDA approval and those that do not. For example what difference does it make if a company is prohibited from claiming that a supplement will lower cholesterol levels but is permitted to claim that a supplement can help maintain normal cholesterol levels. Such distinctions will be lost on most consumers.
The final rule is not entirely FDA’s fault. Congress tied the agency’s hands with weak legislation that allows companies to make unfounded claims. Congress should require supplement producers to demonstrate that supplements are safe and that claims are true.”
Contact Jeff Cronin (jcronin[at]cspinet.org) or Ariana Stone (astone[at]cspinet.org).