An editorial in the New England Journal of Medicine published in the 1 February edition calls for tougher regulations in light of egregious violations of the Dietary Supplement Health and Education Act (DSHEA) and lax enforcement of existing regulation by the US Food and Drug Administration (FDA).
The editorial's author, Pieter Cohen, MD, of Harvard Medical School, notes that since DSHEA was passed in 1994, the number of dietary supplements on the market has exploded from 4,000 in 1994 to more than 55,000 in 2012. Only 170 new supplement ingredients have been submitted to the agency during that time for safety assessment purposes.
Cohen notes that FDA has proposed new guidance on the existing DSHEA regulations, which allow the agency to require industry to prove that their product exhibits a "reasonable expectation of safety." The new guidance on New Dietary Ingredients (NDI) would require in vitro, animal and tolerability testing for new products or products marketed at greater doses than their historical norms. Further, the guidance would make distinctions between new and old ingredients, including what manufacturing methods would make an ingredient "new".
While Cohen lauds FDA for its efforts, he does "not believe the FDA has gone far enough," saying that FDA's acceptance of historical data instead of experimental data doesn't take into account the poor methodology of historical data and lack of adverse event tracking.
"Furthermore, the FDA would not require studies in humans for ingredients lacking documented historical use. Under the guidance, not even single-dose tolerability studies in humans would be required for these novel ingredients," said Cohen. "Finally, the guidance would not mandate that all data - both favorable and unfavorable - be submitted to the FDA; a manufacturer could perform multiple studies and submit only the favorable data."
The proposed guidance has come under fierce attack from the supplement industry. "If the supplement industry were subjected to pharmaceutical industry-like regulation, consumers would bear the burden of increased costs and reduced availability to a wide variety of products," Duffy MacKay of the Council for Responsible Nutrition said in a statement to Natural Products Insider.
FDA, led by the Division of Dietary Supplement Programs Director Daniel Fabricant, has pushed back, calling the gap between the marketed supplements and dietary ingredients subjected to FDA review over the last decade and a half unacceptably large.