August 24, 2000

Re: GRAS Notice No. GRN 000035

Dear Dr. Dushenkov:

The Food and Drug Administration (FDA) is responding to the notice, dated November 16, 1999, that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received your notice on November 17, 1999 and designated it as GRAS Notice No. GRN 000035.

The subject of your notice is hempseed oil. The notice informs FDA of the view of Consolidated Growers and Processors, Inc. that hempseed oil is GRAS, through experience based on common use in food, for use as a flavoring agent, adjuvant solvent, vehicle, stabilizer, thickener, emulsifier, or texturizer in food at the minimum amount required to produce the intended technical effect.

Data and information that you present to support the GRAS determination

We summarize below the information that you provide to support your position that the use of hempseed oil in food is GRAS through experience based on common use in food.

FDA's evaluation of the data and information in your notice

Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the FFDCA), a substance that is added to food is not subject to the requirement for premarket approval as a food additive if its safety is generally recognized, among qualified experts, through experience based on common use in food. Under 21 CFR 170.3(f), "common use in food" requires a substantial history of consumption for food use by a significant number of consumers. Thus, the fact that something may be used as a food does not, in itself, demonstrate that such use is safe, unless that use is sufficiently broad to demonstrate to qualified experts that the use in food demonstrates safety. Accordingly, we have evaluated your submission in the context of whether the uses that you describe demonstrate safety.

FDA evaluated Items 1 through 4 (in the table above) under the standard set forth in 21 CFR 170.3(f). In FDA's view, the limited use of hempseed oil that these references describe does not constitute evidence of a substantial history of consumption for food use that is required under 21 CFR 170.3(f) to demonstrate safety.

FDA also evaluated Item 5 under the standard set forth in 21 CFR 170.3(f). In FDA's view, the referenced statement that hempseed oil rarely was used for food undermines your position that hempseed oil was commonly used in food prior to 1958.

Under section 201(s) of the FFDCA, a GRAS substance must be generally recognized as safe "under the conditions of its intended use." Because Items 6 through 10 describe the use of hemp seeds rather than hempseed oil, FDA did not consider these references to be relevant to the intended use that you describe in your notice.

FDA obtained a copy of Executive Order 12919, which supersedes Executive Order 10480. Executive Order 12919 delegates authorities and addresses national defense industrial resource policies and programs under the Defense Production Act of 1950. Executive Order 12919 defines "food resources" for the purpose of the Executive Order as a variety of agricultural commodities, including wool, tobacco, mohair and other materials. Given this context, it is FDA's view that this Executive Order does not provide evidence of experience based on common use in food within the meaning of section 201(s) of the FFDCA.

The electronic mail message from the Consumer Education Staff in FDA's Center for food Safety and Applied Nutrition answered a question from a consumer. That question was whether hempseed oil has been approved by FDA for use as a food or as a food additive. The response from the Consumer Education Staff does not address the question, raised by your notice, whether there was a substantial history of consumption for food use by a significant number of consumers prior to 1958. Moreover, under 21 CFR 10.85(k), the opinion expressed in that electronic mail message that hempseed oil is an eatable oil is an informal opinion that represents the best judgment of the Consumer Education Staff at that time; that electronic mail message does not necessarily represent the formal position of FDA and does not bind or otherwise obligate or commit the agency to the views expressed.

Conclusions

FDA has evaluated the information that you discuss in your GRAS notice as well as other data and information that are available to the agency. Your notice describes some use of hempseed oil within one foreign country but does not show that use was sufficiently widespread to demonstrate safety. Your notice also cites a reference that hempseed oil rarely was used for food; describes uses of the related substance, hemp seed; references an Executive Order that includes hemp and several other inedible products in its definition of food resources for the purposes of that Executive Order; and cites an electronic mail message of an FDA employee in response to a question from a consumer about whether hempseed oil has been approved by FDA. As Dr. Linda Kahl of the Office of Premarket Approval discussed with you by telephone on April 7, 2000 and June 9, 2000, it is our view that this information does not provide a sufficient basis for a determination that hempseed oil is GRAS, through experience based on common use in food, under the proposed conditions of use. Given that you based your GRAS determination on common use in food, we did not evaluate whether there would be a basis for GRAS status through scientific procedures.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the Internet (at http://vm.cfsan.fda.gov/~lrd/foodadd.html).

⁽¹⁾In response to our telephone request on January 7, 2000, you provided a copy of this reference. Although your notice describes the date of this reference as "1986," the copy that you provided indicates that this reference dates from 1896 rather than 1986.

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