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FDA Extends Animal Food Rule Comment Period

FDA has announced that it is extending the comment period on its proposed rule regarding Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals until March 31, 2014.  FDA is also extending the comment period on the related Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm to the same date.

Gear Up for the FDA’s Menu Labeling Regulations

Gear Up for the FDA’s Menu Labeling Regulations

January 23, 2014

Authored by: Sara Ahmed and Brandon Neuschafer

The FDA’s highly anticipated proposed rules regarding menu labeling are set for release just around the corner, and businesses and elected officials are already reacting.

The proposed rules apply to chain restaurants, retail food establishments, and vending machines with 20 or more locations and require that menus be labeled with caloric information and that certain nutritional information be made readily available to patrons.

While some chain retailers applaud the idea of nationwide uniform labeling requirements for the sake of ease, others are concerned about the cost and efficacy of the proposed rules.

Domino’s CEO J. Patrick Doyle has been a dissonant voice in the debate since 2011.  Maine’s Senator Angus King is another critic, and joining him are both members of the Senate and House that have sponsored S. 1756 and H.R. 1249 , bills aimed at amending the FD&C Act.  Congresswoman Renee Ellmers, who supports the amendment, claims that the FDA’s proposed “one-size-fits-all

Bryan Cave Obtains Dismissal of Nutritional Supplement Patent Infringement Litigation

January 20, 2014


Bryan Cave has been in the news recently for its representation of Pinnaclife Inc., regarding patent protection for nutritional supplements.  A California federal trial court judge dismissed claims that Pinnaclife infringed CreAgri Inc.’s patents for olive-based, anti-inflammatory supplements, ruling that CreAgri didn’t know the supplement would reduce inflammation when it filed the patent. San Francisco Partner Lee Marshall was quoted saying that Pinnaclife was glad the court recognized the importance of data in designing nutritional products. Litigation over nutritional supplements is increasing, he said, and many supplement patents lack the analytical rigor of pharmaceutical drugs. “If you have a nutritional supplement or a pharmaceutical drug, and you think it’s going to work, that’s not enough to get a patent,” Marshall said. “You need good data to demonstrate efficacy.”

The case is CreAgri Inc. v. Pinnaclife Inc., Case No. 5:11-cv-06635 in the United states District Court for the Northern District of California.

Want to Export Diary Products to China?

January 20, 2014


China has recently modified the requirements for imports of milk and dairy products into the country, and FDA is working to assist US producers and manufacturers compete in the Chinese market.  FDA has begun preparing a list of milk product manufacturers and producers who want to export into China, as China has indicated that products from manufacturers and producers not on the list may be denied entry into China.  For purposes of this list, “milk product” does not include raw milk, but does otherwise include milk products as identified in 21 C.F.R. 1240.3(j).

Participation in the list is voluntary, and interested entities “cannot be subject to any pending judicial enforcement action or a pending FDA warning letter, and would need to either have had a FDA inspection within 3 years, or be on the Interstate Milk Shippers List or the U.S. Department of Agriculture list, Dairy Plants Surveyed and

FDA Declines To Determine Whether GMOs Are “Natural” (But The Debate Is Far From Over)

GMOs have been in the news a lot recently, from General Mills’ announcement that Cheerios will be labeled GMO-free to apples that don’t rust.  One important development that has received less attention is FDA’s decision to decline an invitation by several judges to define whether “natural” and “all natural” claims can be used with respect to products containing GMOs.  The request came from three federal judges district court judges, two in California and one in New Jersey, whose dockets have pending lawsuits alleging consumer fraud by food manufacturers who market (or marketed) products containing GMOs as “natural.”

In its response to the judges, FDA stated that although it does have a policy on what “natural” means with respect to food (“nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be

Litigation Heats Up Surrounding the Validity of COOL After Appellate Arguments

The battle continues between key players in the meat industry against USDA’s Country of Origin Labeling “COOL” law, which was finalized in May 2013.  On January 9, 2014, the U.S. Court of Appeals for the D.C. Circuit heard oral arguments.

COOL requires retailers licensed under the Perishable Agricultural Commodities Act to label certain meat products with information regarding where the animal was born, raised, and slaughtered.

On the one hand, Plaintiffs American Meat Institute et al. argue that COOL infringes the meat industry’s First Amendment rights and is wasteful and costly for the meat industry based on USDA estimate that COOL compliance will cost somewhere between $53.1 million and $192.1 million.  On the other hand, USDA’s counter-arguments focus on a consumer’s “right to know” his/her food.

If other labeling laws, which have had mixed results, are any sort of indication, it is fair