Potential Park Doctrine Case?

FDA announced a food seizure at a Ridgewood, N.Y. warehouse that manufactures and distributes kosher food products, after FDA investigators found widespread rodent infestation in the facility.  The agency press release cited conditions including “live rodents, a dead, desiccated rodent, and what appeared to be rodent tracks, rodent gnaw holes, and rodent excreta pellets in or near food products.”

If this sounds familiar, it should.  The facts, on first blush appear to bear resemblance to those in the famous case of U.S. v. Park, which cemented strict liability for violations of the Federal Food, Drug, and Cosmetic Act.   In Park, “there was still evidence of rodent activity in the building and in the warehouses and we found some rodent-contaminated lots of food items.”

As the agency has been itching to increase use of the Park Doctrine since the start of Commissioner Hamburg’s tenure, it will be interesting to see if FDA uses the similar facts to pursue a criminal charge.

FDA yanks soy lecithin labeling exemption without warning – very poor form

Without warning to industry, the Food and Drug Administration’s (“FDA”) withdrew their May 2, 2006 guidance document entitled “Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act” (the “2006 Guidance”), in essence yanking six years of precedent and labeling practices with respect to labeling soy lecithin as an allergen.

As background, the 2006 Guidance had announced that FDA had chosen to exercise its enforcement discretion with regards to food labeled on or after  January 1, 2006, in which lecithin derived from soy was used solely as a component of a release agent and the label for such food did not declare the presence of soy as required under the Food, Drug and Cosmetic Act (“FDCA”).  On February 25, 2013, at 78 FR 12761, FDA published a notice of withdrawal, entitled “Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance” (the “Withdrawal”) that indicates that FDA is withdrawing its enforcement discretion as outlined in the 2006 Guidance due to its belief that “… there has been sufficient time for all manufacturers of foods that use lecithin derived from soy as a component of a release agent to revise the labels for such foods to be consistent with the requirements of [the regulations].. . .” and that FDA “. . . no longer believe[s] it is appropriate to consider the exercise of . . . enforcement discretion with regard to foods that use lecithin derived from soy as a component of a release agent . . .”

The FDA provided virtually no advanced warning to the withdrawal.  There are questions as to whether FDA complied with its internal policies in issuing this withdrawal.   In addition, the experts we have spoken with believe there is no health concern with this use of soy lecithin.   FDA’s action, if it stands, will require allergen labeling for food products processed using soy lecithin as a release agent.

The agency’s decision to withdraw the guidance may be grounded in some unknown health issue.  However, the fact that we have no clear understanding of the agency’s underlying reasoning and no warning is just bad form on the part of the agency.

UK Meat Industry to Start DNA Testing in Wake of Horse Meat Scandal – Indication of Growing Expectations for the Food Industry

The UK Meat Industry plans to introduce DNA testing in wake of the horse meat scandal of  recent months.  The issue is of course one of economic adulteration/fraud and not one of safety (at least from initial reports, and lets not forget the ill-advised and now reversed “ban” on horse slaughter in the US).

The big picture, however, points to the increasing expectations of the food industry to implement programs to identify and prevent economic adulteration.

FDA Announces Final Rule on Administrative Detention of Food

The U.S. Food and Drug Administration (FDA) today announced a final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. This action makes the criteria consistent with changes to the Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act (FSMA). The final rule adopts the interim final rule “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” published in May 2011, without change. The interim final rule amended the criteria for ordering administrative detention to permit FDA to administratively detain food it believes is adulterated or misbranded. The interim final rule became effective in July 2011.

Before the passage of FSMA, FDA was able to detain a food product only when it had credible evidence that a food product presented a threat of serious adverse health consequences or death to humans or animals. Under the final rule, the FDA can detain food if it believes that the food is adulterated or misbranded. The agency can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether to take further enforcement action, such as seizure.

For more information: