FDA Law Blog: Could The Delaney Clause Rear Its Head Yet Again?

FDA Law Blog: Could The Delaney Clause Rear Its Head Yet Again?

Could The Delaney Clause Rear Its Head Yet Again? Posted: 05 Oct 2017 06:45 PM PDT By Ricardo Carvajal – Occasionally we peruse FDA’s inventory of food and color additive petitions under review as a reminder of what might lie on the horizon.  The current list includes some that have gotten considerable attention, and others that have largely flown below radar.  Among the latter, one stands out for its potential to offer a reminder of the nettlesome nature of the Delaney Clause. By way of background, the Delaney Clause is a provision in the FFDCA that prohibits FDA from approving a food additive if it is found to induce cancer in man or animal, and is so named after the legislator who insisted on its inclusion in amendments to the FFDCA (there actually is more than one such provision in the FFDCA, but that’s beyond the scope of this posting.)  Attacked from the beginning as an unscientific approach to the complex challenge of assessing potential carcinogenicity, the Clause has spawned literally decades of litigation as the agency worked to administer it in light of our advancing scientific understanding of the disease – or rather suite of diseases – that it was intended to address. One of the food additive petitions under review invokes the Delaney Clause to ask that FDA amend its food additive regulations to disallow the use of seven synthetic flavoring substances, and to prohibit their use.  The petition contends that the substances have been found to induce cancer in man or animal by the National Toxicology Program of the U.S. Department of Health and Human Services, as well as the California Environmental Protection Agency’s Office of Environmental Health Assessment (the office that administers Proposition 65).  Submitted by a coalition of consumer advocates and filed on January 4, 2016, the petition is getting long in the tooth.  The FFDCA establishes a 6-month timeframe for the review of food additive petitions.  Although extensions are the norm, recent history has shown that consumer advocates are disinclined to wait indefinitely for agency action.  Thus, as the 2-year anniversary approaches for this petition, it’s reasonable to expect movement either in the form of a substantive response by the agency, or a lawsuit to compel action. If indeed the substances in question are found to induce cancer in man or animal within the meaning of the Delaney Clause, then FDA’s hands may be tied – regardless of whether the currently approved uses of the substances meet the safety standard otherwise applicable to food additives (reasonable certainty of no harm).  The resulting revocation of food additive approval could call into question the regulatory status of any foods to which those substances have been added.  Further, it could prompt additional petitions seeking similar action with respect to other substances for which there is evidence of human or animal carcinogenicity.  Ultimately, the only fix might lie in a statutory amendment that would – once and for all – bring the FFDCA’s approach to potential carcinogens in line with contemporary scientific understanding.  Anyone want to take odds on that outcome?