In Apparent Shift, FDA Engages on “Natural”

By Ricardo Carvajal –

FDA is publishing a Federal Register notice asking for information and comments on the use of the term “natural” in human food labeling, “including when, if ever, the use of the term is false or misleading.”  The notice purports to be based partly on the agency’s receipt of three citizen petitions asking for a regulatory definition, and a fourth asking that the term be prohibited.  The notice also acknowledges requests from several Federal courts for an administrative determination on use of the term “natural” for foods containing bioengineered ingredients – requests that the agency thus far has denied (see our previous post here).

The publication of the notice comes as somewhat of a surprise, given that the agency had indicated little interest in revisiting its longstanding policy on “natural.”  However, recent developments – including deepening controversy over the labeling of bioengineered foods and whether such foods qualify as “natural” – may have prompted a reassessment of the merits of expending agency resources on the issue.  In addition to the requests for an administrative determination noted above, FDA received a citizen petition from the Grocery Manufacturers Association asking in part for the issuance of a regulation authorizing “natural” claims on bioengineered foods.  Although not mentioned in FDA’s notice, Vermont’s new GMO labeling law will prohibit such claims on foods marketed in that state, assuming the law withstands judicial challenge.  Accordingly, one of the sixteen issues on which FDA requests comment is whether agricultural practices such as genetic engineering should be factored into any revised definition of “natural.”

We anticipate that issues not raised in FDA’s notice will be raised in comments to the docket.  For example, as we noted in a prior posting, USDA has issued draft guidance (see here and here) on the determination of whether a substance is natural or synthetic for purposes of organic food labeling – a distinction that has been cited in litigation challenging the use of “natural” claims.  Stakeholders would thus be well advised to monitor FDA’s docket, which is expected to go live on November 12.