FDAs New Sneak Attack on Supplements
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.
Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute New Supplement in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplementsand if so, under what rules.
Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIsthat is, on new supplements. They had to do this because it was mandated by the recent Food Safety Modernization Act.
We have reviewed the very complicated new regulations in detail. In the hands of an agency charged with regulating supplements fairlyone not hostile to supplements the way FDA isthey might be made to work. But in the hands of the FDA, which wants everything, supplements and drugs alike, to go through the vastly expensive new drug approval process, we fear the new rules will be used to forbid the development or sale of any new supplementswhere new means anything after 1994, when DSHEA was passed.