The just-released New Dietary Ingredient draft guidance from FDAwill likely cause a lot of heartburn for ingredient suppliers and dietary supplement manufacturers and marketers, and it should. Of course, FDA has been hinting at its position for years now, suggesting that new extraction techniques would likely lead to an ingredient being considered an NDI, that new combinations of ingredients could create the need for a new NDI submission, etc. DSHEA created this NDI concept in 1994 and it has taken FDA almost 17 years to actually provide its opinion in the form of a guidance document. But, the document is here, and if you are in the supplement industry, you need to read it. There is still the opportunity to submit comments, but this document does express FDA's current thinking...and it ain't good. We are partnering with the Council for Responsible Nutrition (CRN) to produce a live webinar examining the document and what it means for industry. For more information or to register, click here.
Here are some highlights from the NDI guidance document:
Is a substance that was a component of a conventional food marketed before October 15, 1994, a NDI if the component was not a dietary ingredient marketed in the U.S. before October 15, 1994?
Yes, assuming the component meets the definition of a dietary ingredient. The mere presence of a substance as a component of a conventional food that was marketed before October 15, 1994 does not establish that the substance was marketed as a dietary ingredient before that date. Similarly, the fact that the component may have been isolated as part of an analytical chemical procedure to examine the composition of the previously marketed food before October 15, 1994, is not sufficient to establish that the component is a pre-DSHEA dietary ingredient or even that it is a dietary ingredient at all. If it is not a dietary ingredient, it is ineligible to be a NDI.
Is a dietary ingredient marketed outside the U.S. prior to October 15, 1994, considered to be a NDI if it was not marketed in the U.S. before that date?
Yes. Submitting documentation that the ingredient was marketed in any other country before this date does not establish that the ingredient is not a NDI. The only kind of marketing that is relevant to whether a dietary ingredient is a NDI is marketing in the U.S. before October 15, 1994.
If I change the manufacturing process for a dietary ingredient that was marketed in the U.S. prior to October 15, 1994, and the changes alter the chemical composition or structure of the ingredient, does that make the ingredient a NDI?
Most likely. If the changes in your manufacturing process alter the chemical composition or structure of the ingredient, the resulting compound is probably a NDI and a notification to FDA would be required. For example, using a solvent to prepare an extract from a pre-DSHEA dietary ingredient creates a NDI because the final extract contains only a fractionated subset of the constituent substances in the original dietary ingredient. In addition, changes that alter the composition of materials used to make the ingredient, such as using a different part of a plant (e.g., using an extract of plant leaves where the root extract from the same plant is a pre-DSHEA dietary ingredient), would create a NDI.
If another manufacturer or distributor has already submitted a notification for a particular NDI, and I intend to market a dietary supplement containing the same NDI, should I also submit a NDI notification?
Yes. Section 413(a)(2) of the FD&C Act (21 U.S.C. 350b(a)(2)) makes clear that any dietary supplement that contains a NDI is deemed adulterated unless the manufacturer or distributor of the dietary ingredient or the dietary supplement submits a NDI notification at least 75 days before introducing it into interstate commerce. The statute places the obligation for submitting the notification on each manufacturer or distributor. The original notifier conducted its safety evaluation based on the characteristics and intended use of the specific product under review, including the composition and labeling of the dietary supplement that the notifier was proposing to market. Any other manufacturer or distributor who wishes to market its own dietary supplement containing the same NDI should submit a NDI notification to FDA explaining its own basis for concluding that this new product containing the NDI will "reasonably expected to be safe" under the conditions recommended or suggested in the new product's labeling.
There is a lot more in this guidance document, but I thought the selections above might be enough to get people to read it.