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Want to Export Diary Products to China?

January 20, 2014

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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

Supreme Court to Hear Dispute Over Allegedly Deceptive Food Labeling

January 14, 2014

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The Supreme Court has agreed to hear a dispute between POM Wonderful and Coca-Cola involving the intersection between FDA food labeling requirements and the Lanham Act’s restrictions against deceptive product labeling and advertising.  At its essence, the Supreme Court is being asked to determine whether a private party can bring a Lanham Act claim against a food manufacturer for a food product whose label otherwise complies with FDA regulations governing the label.

POM Wonderful and Coca-Cola have been entrenched in litigation for years surrounding Coca-Cola’s marketing of pomegranate blueberry juice that contained only small amounts of pomegranate and blueberry juices (about 0.3% and 0.2%, respectively) and larger amounts of apple and grape juices.  POM Wonderful has long argued that Coca-Cola’s use of the term “pomegranate blueberry juice” is misleading to consumers given the actual ingredients in the product.

In 2012, the Ninth Circuit Court of Appeals determined that POM Wonderful could not

FDA Begins Accepting Electronic Submittal of Dietary Supplement Adverse Event Information

January 13, 2014

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On January 13, 2014, FDA announced that it would begin accepting adverse event information on dietary supplements electronically.  This policy applies to voluntarily-submitted information as well as information where reporting is mandatory (information submitted via the 3500A and 3500 forms).  As stated by FDA:

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), the manufacturer, packer, or distributor of a dietary supplement whose name appears on the label of a dietary supplement marketed in the United States is required to report to the FDA any serious adverse events received regarding their dietary supplement products when used in the United States.

Reporting of dietary supplement adverse events is critically important in protecting consumers’ health and safety. The FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product specific registration requirement, adverse event reporting is invaluable in

FDA Publishes Draft Rule to Address Intentional Adulteration of Food

FDA published a draft rule today designed to require the largest food businesses in the United States to take steps to address vulnerabilities in their operations to prevent the intentional adulteration of food – “food terrorism,” in other words.  The proposed rule will generally apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility.  Exempted from the rule are small businesses (less than $10 million in annual food sales), farms, food for animals, certain food holding facilities, and certain packing or labeling facilities.  As explained by FDA:

Under the proposed rule, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities then would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working,

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