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FDA Releases Final Rule Allowing Voluntary Risk Reviews of Food Additives to Continue

The Food and Drug Administration (FDA) says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” (GRAS) reviews.

The agency recently released its GRAS final rule for its food additive program, switching reviews from a more formal but slower “petition-based” process to a voluntary “notification” process.

Under the federal Food, Drug and Cosmetic Act (FD&C Act), any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

The use of a food substance may be GRAS either through scientific procedures or, for a substance used in food

The FDA Dishes Out Food Label Changes

The current food label will soon be no more. After two decades, the Food and Drug Administration (FDA) just finalized the new Nutrition Facts label for packaged foods. Making it easier for consumers to make better informed food choices, the FDA announced that the changes are based a combination of public input, updated scientific information, new nutrition and public health research, and more recent dietary recommendations from expert groups.

For more information on the label changes from the Bryan Cave Food and Beverage Industry Team, see this client alert.

The European Commission Takes Back the Reins on Novel Food

With the continuing influx of foreign foods, algae, insects, microorganisms and foods with new molecular structures in our diets, the European Union has decided to put in place a harmonized procedure to vet – or not – these “novel foods” before they are placed on the market. This procedure is set out in the recent EU-wide Regulation which will enter into force beginning 2018. “Novel food” is defined as any food product which was not generally consumed in the European Union before 1997 (the date of the first European legislation on this subject) or innovative food developed using new technologies.

Bryan Cave lawyers Kathie Claret and Raphael Roditi prepared this article on the new regulation, which will be of interest to food manufacturers and importers in the EU.

What do FDA’s Preventive Controls Rules Actually Mean?

St. Louis Partner Brandon Neuschafer authored an article Nov. 10 in Refrigerated & Frozen Foods magazine concerning the FDA’s Preventive Controls Rules. Released on Sept. 10, the rules aim to shift the focus of U.S. food safety away from incident response and toward prevention. “FDA expects that many large facilities are already doing a vast majority of what is now being required,” Neuschafer wrote. “Those facilities may still need to develop additional documentation or tweak procedures. Interesting and complicated issues swirl around companies who are not themselves food facilities, but are technology and equipment providers to such facilities.” Click here to read his full article.

The Demise of Country of Origin Labeling (COOL)

The Demise of Country of Origin Labeling (COOL)

May 26, 2015

Authored by: Sara Ahmed

Digest has been tracking the U.S. Country of Origin Labeling (“COOL”) rules that the WTO decided last year violate international fair trade rules.  It was the third time the WTO found COOL to be unfairly discriminatory.

In response to the threat of retaliation by Canada and Mexico, last week, the House Agricultural Committee voted to repeal a portion of COOL.  Under the bill, beef, pork, and chicken products will likely no longer state where the animals were born, slaughtered, and packaged.  The USDA had previously tried to no avail to revamp the rules upon the WTO’s prior rulings.

The U.S. National Farmers Union’s President, Roger Johnson, has been vocal in his feelings against the move to repeal portions of COOL and stated: “The House Agriculture Committee has succumbed to lobbying and scare tactics from foreign governments and multinational meatpackers and inserted itself prematurely into the WTO process by voting for a bill

WTO Rules on Country of Origin Labeling

WTO Rules on Country of Origin Labeling

October 23, 2014

Authored by: Sara Ahmed

You may recall prior Digest posts regarding the World Trade Organization’s evaluation of the validity of the US Country of Origin Labeling (“COOL”) law.

On Monday, the WTO decided against the United States and has held that the COOL violates international fair trade rules. This is the third time the WTO has found COOL to be unfairly discriminatory and it is instigating Canada and Mexico to prepare to impose trade sanctions on US products such as wine and chocolate.

Consumer groups have also voiced their disappointment about the recent decision. Renee Hunt, a spokeswoman for the Ohio Ecological Food and Farming Association, an organic advocacy group, said: “It comes at the expense of consumers and American livestock farmers…Consumers want to have the choice of where their meat comes from, but, instead, Big Ag’s interests are protected.”  Chris Waldrop, policy director at

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