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The Daily Intake

Legal and Regulatory updates for the food and supplement industry

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FVM Futures

Posted on July 19, 2016

FDA releases Foods and Veterinary Medicine (FVM) program’s future plans.

  • FDA’s Foods and Veterinary Medicine (FVM) program encompasses the Office of Foods and Veterinary Medicine (OFVM), the Center for Food

…
Continue Reading FVM Futures

Recalls Revisited

Posted on June 9, 2016

HHS OIG issues early alert criticizing FDA’s food recall procedures.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has

…
Continue Reading Recalls Revisited

Honing in on “Healthy”

Posted on May 10, 2016

FDA to revisit definition of “healthy” on food labels.

  • FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  

…
Continue Reading Honing in on “Healthy”

Pets and Vets: Therapeutic Vet Diet CPG Finalized

Posted on May 3, 2016

FDA finalizes enforcement policy with respect to therapeutic veterinary diets.

  • As a general matter, companies may not make therapeutic or “drug” claims in connection with the marketing of food or

…
Continue Reading Pets and Vets: Therapeutic Vet Diet CPG Finalized

Lunch Lines, Lunch Fines

Posted on March 30, 2016

USDA proposes rule to enhance enforcement of nutrition standards in schools.

  • Enacted in 2010, the Healthy, Hunger-Free Kids Act (HHFKA) set nutrition standards for schools.  First Lady Michelle Obama is

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Continue Reading Lunch Lines, Lunch Fines

Ninth Circuit Neutralizers

Posted on March 25, 2016

Ninth Circuit puts food labeling challenge on hold pending FDA action.

  • As food industry stakeholders are well aware, “natural” claims invite the risk of consumer class action challenges in the

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Continue Reading Ninth Circuit Neutralizers

Cheese Controls

Posted on February 9, 2016

FDA revisiting its safety criteria for raw milk cheese.

  • For years, FDA has been warning consumers about the potential health risks associated with consuming raw milk products (i.e., products made

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Continue Reading Cheese Controls

Ample Samples

Posted on November 30, 2015

FDA targets cucumbers and hot peppers as part of its FY 2016 sampling program.

  • Since 2014, FDA has been developing a robust surveillance sampling program intended to promote food safety. 

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Continue Reading Ample Samples

The Nuances of “Natural”

Posted on November 10, 2015

FDA requests comments on “natural” definition.

  • As food industry stakeholders are well aware, the use of the term “natural” in food labeling and advertising is fraught with ambiguity and risk

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Continue Reading The Nuances of “Natural”

IND Inroads

Posted on October 30, 2015

FDA stays portions of IND guidance and provides greater flexibility to research health benefits of foods.

  • As a general matter, human clinical research studies to evaluate the therapeutic benefits of

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Continue Reading IND Inroads

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Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm’s attorneys on matters of technical complexity. Many of our attorneys also have government experience and expertise in multiple areas of the law.

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