Development of a List of Pre-DSHEA Dietary Ingredients - PowerPoint Presentation

Development  of a List of Pre-DSHEA Dietary Ingredients
Development  of a List of Pre-DSHEA Dietary Ingredients

Development of a List of Pre-DSHEA Dietary Ingredients - Description

October 2017 Is this a safe harbor Or a rabbit hole 2 FDAs resources including inspections and oversight are dwarfed by the size and scope of the DS industry Already we see that adulterated and dangerous supplements including powdered and liquid highly concentrated caffeine ID: 714737 Download Presentation


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Development of a List of Pre-DSHEA Dietary Ingredients

October 2017Slide2

Is this a “safe harbor”?

Or a rabbit hole?


FDA’s resources, including inspections and oversight, are dwarfed by the size and scope of the DS industry.

Already we see that adulterated and dangerous supplements, including powdered and liquid highly concentrated caffeine,


, and others are left on shelves until consumers are hurt or killed.

Perhaps all of FDA’s resources should instead be directed to examining the data – for example, on Yohimbe – and getting the most dangerous or adulterated supplements off the market.

The risk here is that FDA will spend time and energy on a list that will be used mainly for marketing purposes by the industry and incorrectly labeled a “safe harbor,” yet the agency will not have made any determination about safety, just prior use, and consumers will again be deeply confused about whether FDA reviews supplements for safety. Slide3

Making the list is worth it if and only if:Industry is not able to use the listing in marketing or labeling claims It requires bona fide, not self-serving or industry-generated, evidence of both identity and prior use (excluding affidavits & trade association lists);

Concurrent with developing such a list, FDA flags pre-94 ingredients that are known to have safety risks at this time, based on the type of safety evaluation outlined in the NDI guidance;

The list upholds many of the key distinctions flagged by FDA in the draft NDI guidance:

It is sensitive to intake level and population exposures;

It excludes synthetics on those terms and


constituents;It excludes changes to identity of source material (e.g., part of the plant) or meaningful alteration from manufacturing process changes; It includes only ingredients marketed for use in a dietary supplement or food ingredients that have not been chemically altered and were used in food;It excludes excipients and processing aids, as well as indirect additives and the other categories identified by FDA in the draft guidance; and…


Making the juice

worth the squeezeSlide4

Novel combinations should not be listed absent a demonstration of safety


“When dietary ingredients are combined, they can interact. In some cases, these interactions can present risks to consumers. For example, adverse effects—such as low blood pressure, low heart rate, gastrointestinal distress, and in severe cases, irregular heartbeat—may occur when a new dietary ingredient with cholinesterase-inhibiting properties (such as


A or galantamine) is combined with another dietary ingredient that is a cholinergic agonist (e.g.,


bark extract). To have a basis to conclude that a dietary supplement that combines an NDI with one or more pre-DSHEA dietary ingredients will reasonably be expected to be safe, it is necessary to consider whether the addition of the other dietary ingredients will affect the safety of the NDI or the resulting dietary supplement.”


7. If I want to market a dietary supplement containing several pre-DSHEA ingredients that haven’t previously been marketed together, do I have to submit an NDI notification?

No. The NDI notification requirement applies only to dietary supplements that contain at least one NDI. If each of the dietary ingredients in a dietary supplement was marketed in the United States before October 15, 1994, marketing these ingredients together for the first time in the same dietary supplement does not create an NDI or trigger the NDI notification requirement.

UNPA Comments: On average, supplements contain 9 ingredients.Slide5

Making the draw on resources match the gain

FDA should first convene a process to examine pre-94 ingredients and combinations that pose a risk to public health;

Once the status of these ingredients is clear, FDA could then proceed to compile a list based on industry submissions of adequate evidence of prior use, as above;

Information on manufacturing process and other aspects of products relevant for identity or safety must be made public;

The list should eventually be made an exclusive repository of pre-94 status (though new applications could be accepted for listing based on evidence);

It should not perpetuate the GRAS loophole (self-affirmed GRAS ingredients should be excluded);

The consequence of exclusion from the pre-94 list merely means companies have to file an NDI and there could be a reasonable time

for doing so.


Thank you!



Director, Regulatory Affairs

Center for Science

in the Public Interest


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