Tuesday, April 17, 2018

Highly Concentrated Caffeine in Dietary Supplements

Products consisting of or containing only pure or highly concentrated caffeine have been linked to deaths and are deemed by FDA to represent a significant public health threat. FDA considers some of such dietary supplements to be adulterated under section 402(f)(1)(A) of the Food, Drug, and Cosmetic Act.

FDA, Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018).

Tuesday, April 03, 2018

First FDA Mandatory Food Recall Order

On April 3, 2018, FDA issued its first mandatory recall order for a food product. The order was issued to Triangle Pharmanaturals LLC for all its all food products containing powdered kratom. The order came after several products were found to contain Salmonella, and the company refused the agency’s request for a voluntary recall.

The Food Safety Modernization Act gave FDA the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA. These requests by FDA are titled, “Notification of Opportunity to Initiate a Voluntary Recall,” but are sometimes called the “last chance letter,” because the letter provides the company with a last opportunity to issue a recall before FDA enforcement action.

Sunday, January 14, 2018

Celebrating 20 years of advancing the understanding of food law at the Michigan State University Institute for Food Laws and Regulations

Tuesday, November 29, 2016

Food Regulation, 2nd edition, is now available!

The second edition of Food Regulation is now available.  It contains over 25 percent new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense. The text provides an in-depth discussion of the federal statutes, regulations, and agencies involved in food regulation. After an introduction to the history of food regulation, it covers current food regulations, inspection and enforcement, international law, and more. 

With explanation of the policies and food science behind the law, the text is designed for both food scientists and lawyers. Yet the book remains accessible to students and professionals alike. This is an excellent text for food science and food law and a practical reference for food industry professionals, consultants, and others. 

I hope you find it appetizing. If you would like more information, the Table of Contents is available here.  A copy of Chapter One is available here.  
To order from the publisher, click here. 
To order from Amazon, click here
To order the iBook, click here

Monday, November 21, 2016

VQIP Guidance Released

FDA has just released its Guidance for Industry: Voluntary Qualified Importer Program. The Food Safety Modernization Act (FSMA) directed FDA to create the Voluntary Qualified Importer Program (VQIP), which is a voluntary, fee-based program that is intended to expedite the review and importation of food for participants in the program.

To be eligible to participate in the VQIP, an importer must be importing food from a facility that has been certified by a third-party auditor accredited under FSMA and such certification must accompany the imported food. An importer that wishes to participate must submit a notice and application to FDA. The specific requirements for participation are outlined in the FDA guidance document.

A hat tip to David Acheson on his excellent summary and comments, You Can Now Expedite Entry of Your Imported Foods … If You Meet All Eligibility Criteria.

Tuesday, October 04, 2016

FDA to Revise the Nutrient Content Claim “Healthy”

The Food and Drug Administration (FDA) announced the start of a public process to redefine the “healthy” nutrient content claim for food labeling.

Under the food labeling rules, “healthy” and similar terms are generally an implied nutrient content claim. 21 C.F.R. § 101.65(d). A food must meet certain requirements to be eligible for the “healthy” claim.

FDA acknowledges that the 1993 regulation for “healthy” as a nutrient content claim is in need of an update. The latest nutrition science and the current dietary recommendations, among other things, has shifted from recommending diets low in total fat to now draw distinctions among the types of fat (unsaturated fats vs. saturated fats and trans fat) in the diet.

While FDA is receiving comments and reconsidering the regulation defining “healthy,” FDA states, “Because the rulemaking process can sometimes be lengthy, we intend to exercise enforcement discretion in the interim with respect to some of the existing criteria for the nutrient content claim “healthy” if the alternative nutrient criteria described below are met.”

FDA Guidance: Use of the Term “Healthy” on Food Labels and FDA’s Enforcement Discretion

Specifically, FDA’s Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not low in total fat, provided that: (1) The amounts of mono and polyunsaturated fats are declared on the label and (2) the amounts declared constitute the majority of the fat content.

The definition for “healthy” also includes a nutrient contribution criterion. Healthy dietary patterns not only restrict nutrients that increase risk of chronic disease, but also help assure nutrient adequacy to ensure sufficient intake of nutrients that are important in sustaining body function and reducing the risk of disease. The current definition of “healthy” focuses on foods providing a good or excellent source of nutrients for which there had been public health concern in 1993: vitamin A, vitamin C, iron, calcium, and dietary fiber.

Nutrient intakes have shifted over time, however, and vitamins A and C are no longer nutrients of public health concern. FDA now recognizes vitamin D and potassium as nutrients that should be encouraged in the diet, in addition to iron, calcium, and fiber.

Therefore, FDA intends to exercise enforcement discretion when the food contains less than ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, and fiber, but the food contains at least 10% of the DV per RACC of vitamin D or potassium.

FDA has requested information and comments docket number FDA–2016-D–2335  FDA also asks for input on issues related to the “healthy” claim, including:
  • Is the term “healthy” most appropriately categorized as a claim based only on nutrient content?
  • What types of food, if any, should be allowed to bear the term ‘‘healthy?”
  • What nutrient criteria should be considered for the definition of the term “healthy?”
  • What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling?
  • What is consumers’ understanding of the meaning of the term “healthy” as it relates to food?
Information and comments must be submitted to FDA by Jan. 26, 2017.

Thursday, July 07, 2016

United States v. Decosters Decision

Yesterday, July 6, the Eighth Circuit upheld the United States v. DeCoster three-month prison sentences and $100,000 fines for Austin “Jack” DeCoster and Peter DeCoster, respectively the owner and chief operating officer of Quality Egg, LLC. Over the years, several salmonellosis foodborne illness outbreaks were associated with eggs from DeCoster farms. In a 2010 outbreak that resulted in the present case, nearly 56,000 were sickened.

In a 2–1 decision, the appeals panel ruled that even though the DeCosters did not know that the eggs they shipped had Salmonella, they “are liable for negligently failing to prevent the salmonella outbreak” and that jail time is appropriate. The Food, Drug, and Cosmetic Act “punishes neglect where the law requires care.” See United States v. Park, 421 U.S. at 671 (the eponymous case for the Park doctrine, also known as the “responsible corporate officer” doctrine).

This case was notable for the number of amici on behalf of the DeCosters: The Washington Legal Foundation, Cato Institute, Chamber of Commerce of the United States, Pharmaceutical Research and Manufacturers of America, and the National Association of Manufacturers. Recently there has been a concerted push for abolishing strict liability from all federal law, including the Park doctrine of the Food, Drug, and Cosmetic Act.

No matter how you feel about mens rea, the DeCosters are poor poster children for eliminating Park doctrine strict liability under the Food, Drug, and Cosmetic Act. Strategically, a proposal to eliminate strict liability that applies to the Park doctrine stakes out a weak position. It defends wrongdoers whose negligence causes tens of thousands of serious illnesses. It defends wrongdoers whose negligence causes the deaths among the most defenseless, children and the elderly. Be prepare to answer the grieving mother who lost a child or the widow or daughter who lost her father, who was a decorated WWII veteran or decorated Korean War veteran.