Successful supplement companies fully understand DSHEA
ingredients (NDIs) are safe before they reach the market, according
to an article in the Food and Drug Law Journal (FDLJ), but the
supplement industry as a whole still needs to get to grips with the
system.
The article, entitled "Premarket Notifications of New Dietary Ingredients - a 10 Year Review" was written by Michael McGuffin, president of the American Herbal Products Association and Anthony Young, a partner at Washington based law firm Kleinfeld, Kaplan & Becker.
"The FDA has developed some consistency in implementing the regulations for new dietary ingredients," said McGuffin. "But, the agency needs to make information available more promptly, and marketers of new dietary ingredients need to better understand the detailed application of these regulations."
Since the DSHEA was passed nearly 10 years ago the FDA has received 145 notices of proposed new ingredients. It has objected to nearly half of these notifications, either because the submissions were incomplete or provided inadequate data to support the safe use of the ingredient, or because the ingredient or the final product did not fall within strict legal definitions.
The article concluded that, "the notification system for new dietary ingredients is working", but that "implementation has been less than perfect".
The authors were much less concerned with procedural hitches than with the need for the supplement industry to whole-heartedly learn how to use the system.
"The fact that so many submissions have been made for dietary supplements, for which no submission is required, simply taxes the resources of companies and the agency," said the authors.
"Every industry relies upon the development of new products," said McGuffin. "Companies that learn to navigate the FDA review process for new dietary ingredients will have a real market advantage in an industry that demands innovation."
The article even goes so far as to suggest that those manufacturers, which do not bother to engage with this regulatory process will fall behind in the long run.
"The ability to provide the requisite information that is the basis for a legitimate conclusion that the ingredient is safe may well differentiate between successful and unsuccessful companies," said the authors.
To help companies comply, the report offers practical suggestions explaning how to file a notification that is acceptable to the FDA.
