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omega-3 Archive

Food Labeling: Why Every Product Needs Attorney Label Review

October 27, 2014

by Jason Foscolo

Labels that do not comply with federal regulations are a significant source of legal liability for food businesses. Even established giants like Bumble Bee Foods fail to understand this from time to time.

Bumble Bee Omega 3

Going All-In on the Omega Claim

Bumble Bee is currently engaged in a lawsuit alleging that its canned and pouched tuna product labels were misbranded and mislead consumers. At the time when the lawsuit was filed, Bumble Bee claimed that its product was an “Excellent Source” of omega-3 fatty acids. As we know from having reviewed lots of labels for clients over the years, omega-3 claims are tricky to make on a food label.

Claims like “excellent source,” which characterize the level of a nutrient in a food, are always defined as a percentage of the daily value for the nutrient. An “excellent source” claim may be made when a food contains at least 20% of the recommended daily intake (RDI).  Therefore, if there is no established daily value for a nutrient, it is not permissible to claim that a food is “high in,” an “excellent source,” or “rich in” the nutrient. While the FDA has established RDIs for certain nutrients, including sodium, vitamin C, and fiber, there is no established RDI at present for omega-3 fatty acids generally. For that reason, Bumble Bee’s claim – regardless of the actual Omega-3 content of the product – was facially defective.

As discussed on our blog, FDA announced this past summer that it would not take exception to “high,” “good source,” and “more” claims specifically for ALA, an omega-3 fatty acid, in certain circumstances. However, all other claims that characterize the level of omega-3s are prohibited.

There is a way to talk about the omega-3 content of the product without the legal exposure. A manufacturer may make a statement about a nutrient for which there is no established daily value as long as the claim specifies only the amount of the nutrient per serving and does not implicitly characterize the level (such as, by saying “high” or “excellent source”) of the nutrient in the product. Such a claim might be “x grams of omega-3 fatty acids.”

This seems like a simple distinction to make but getting it wrong has big implications. No claim should ever go onto a food label without a thorough review from someone familiar with the regulations.

FDA Prohibits Certain Omega-3 Claims

June 23, 2014

by Jack Hornickel

The FDA recently issued a final rule prohibiting the use of certain nutrient content claims regarding omega-3 fatty acids. After a lengthy review of proposed claims submitted by three companies, FDA refused to permit claims such as “good source of,” “high in,” and “fortified with” docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), while allowing certain claims regarding alpha-linolenic acid (ALA) content. The rule becomes effective January 1, 2016.

Fortified with . . . stench

Fortified with . . . stench

The reason for FDA’s decision is quite logical. Under the Food, Drug, and Cosmetic Act, food producers can request official permission to use nutrient content claims, accompanied by supporting research from the National Academy of Sciences or some other federal health authority. Among other requirements, the request must prove that the nutrient content claim accurately represents the scientific research. Because phrases such as “good source of,” “high in,” and “fortified with” clearly imply a better-than-average nutrient content, the scientific research must identify a daily reference value of the nutrient — in other words, how much of the nutrient we should have in our diets.

After reviewing the provided scientific research from the Food and Nutrition Board of the Institute of Medicine at the National Academy of Sciences, FDA was not convinced. The scientific authority, FDA decided, did not accurately identify a baseline nutrient level to which the claims referred. Thus, without an adequate scientific basis, the nutrient content claims do not convey meaningful information; rather, they mislead consumers.

Omega-3 fatty acids are found in a number of food products and ingredients: soy, walnuts, canola oil, flaxseed, hempseed, chia seed, liver, fish, eggs, algae, and seaweed. Omega-3s are widely believed to reduce inflammation, and risk of heart disease and cancer. Thus, while the new FDA rule seeks to protect consumers from the proverbial snake oil salesman, it leaves consumers to refer to sites such as veganhealth.org and DHAbaby.com for tips on what foods are a “good source of” omega-3s. Food manufacturers may continue to make accurate labeling claims identifying the omega-3 content of their products, such as “contains ___ mg of DHA omega-3 fatty acids per serving.”