Can I import food for an industry conference WITHOUT an FSVP?

“Can I import food for an industry conference without an FSVP?”

This is one of the most common questions we receive and one that FDA answers explicitly in their recent FSVP Draft Guidance in the context of “food for research or evaluation”:

A.26 Q: Does the exemption for food for research or evaluation include food imported for consumption or distribution at trade shows?
A: Generally, no. Because food imported for consumption at trade shows typically is sold or distributed to the public generally (i.e., anyone who attends the trade show), exempting such food from the FSVP regulation would be inconsistent with the exemption provisions for food imported for research or evaluation stated in Question A.23 (see section 805(f) of the FD&C Act and 21 CFR 1.501(c)(1)). However, the exemption for research or evaluation would apply to food used in a defined study, conducted during a trade show, of a food involving a discrete set of test subjects who have agreed to participate in the study, because it does not appear that such food would be sold or distributed to the general public.

If you intend to leverage exemption 21 CFR 1.501(c), we recommend the following documenting the following information:

Prior to importation

While the “test subjects” may change following importation, consider documenting on company letterhead, prior to the trade show, the following information.

  • Dates and location of the trade show

  • Names and contact information for “test subjects”  and individuals responsible for the handling and of the research/evaluation activities related to the food

  • Name and expected quantity of food intended for each person, or to be shared by test subject group(s) (It should be realistic)

  • Procedures for receiving and storing food, prior and during the trade show, and for handling excess food (following the trade show) to ensure that it is not made available to the general public or unintended subjects

During the trade show

Consider maintaining a “sign-in” sheet to substantiate your use of imported food was restricted to the designated test subjects..

After the trade show

If you intend to destroy the food (or preserve it for another evaluation), consider generating a record that documents your actions. We recommend a table with rows that identify food and column that address units used, preserved and destroyed. Photos would be a valuable, supplemental record.

Don’t forget the conditions for the exemption!

If you intended to benefit from the “research and evaluation” exemption, you need to comply with all of 21 CFR 1.501(c), which states the following:

(c) Exemption for food imported for research or evaluation. This subpart does not apply to food that is imported for research or evaluation use, provided that such food:

(1) Is not intended for retail sale and is not sold or distributed to the public;
(2) Is labeled with the statement “Food for research or evaluation use”;
(3) Is imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of; and
(4) Is accompanied, when filing entry with U.S. Customs and Border Protection, by an electronic declaration that the food will be used for research or evaluation purposes and will not be sold or distributed to the public.

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