DSHEA Requires Notification for Ingredient or Supplement?

Industry is not sitting quietly on FDA’s new dietary ingredient (NDI) Draft Guidance. At least that was the sense at the United Natural Products Alliance’s two-day seminar on the guidance, July 26 and 27. Industry takes issue with many aspects, including some nutrients not even being considered dietary ingredients, let along NDIs; a lack of an old dietary ingredient (ODI) list; and manufacturing changes to an ODI triggering an NDI.

But at the heart of the issue is FDA’s take that each supplement requires a NDI notification. For the past 17 years, since DSHEA’s passing, industry has thought of this as an ingredient notification, not a supplement notification. Industry says this was the intent of Congress when it passed the Dietary Supplement Heath and Education Act of 1994. Requiring notification on each supplement would stifle innovation and would create adulterated products out of most of what is on the market.

In DSHEA, industry says, Congress clearly separated supplements from food additives and drugs, creating less of a burden on supplements due to lesser risk of harm. However, requiring every new supplement to have an NDI notification, as is required per FDA’s thinking, many believe industry’s burden is heavier than what applies to food and is equal to that of drugs.

If a drug manufacturer changes a manufacturing process, it must notify FDA. According to FDA’s Draft Guidance, if a supplement maker changes a manufacturing process that chemically changes an ingredient, it must submit a notification.

Compared to food, if a frozen food maker adds sausage to its meat lovers’ pizza, it does not require FDA notification. However, for supplement manufacturers, adding a new ingredient to an existing botanical blend could require a notification per the Draft Guidance.

From FDA’s stance, the whole supplement is what matters when it comes to public safety. Two ingredients may be safe, but if you add in another, introduce a new manufacturing method and combine with an emulsifier, it might not be safe.

But, that’s not was Congress said, according to industry.

Still, it’s difficult to prove Congress’s intent, and it comes down to what DSHEA says: “There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe,” per section 413(a)(2) (emphasis is mine).

So, what does this say? FDA says this means each supplement. If industry thinks this means each ingredient, now it the time to tell FDA via the comments. What do you think? Did FDA misunderstand DSHEA?