On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD). Continue Reading Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products. Then last fall FDA released a new guidance document on what constitutes a “healthy” food and proper labeling of such foods, and the Agency simultaneously requested public input on a significant number of questions related to use of this particular claim.

Last week, FDA announced two actions that are intended to further advance this public consultation process for “healthy” label claims. First, it has extended the comment period that was initiated in October with the release of the draft guidance document until April 26, 2017. And it is convening a public meeting to discuss the use of the term “healthy” in the labeling of human food products, in part to further the feedback that may be received during this ongoing comment period. Continue Reading Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling.  In addition, while the process is underway, the Agency intends to exercise enforcement discretion for (meaning it will not take action against) foods labeled with the term “healthy” as long as they meet the conditions in the regulatory definition at  21 CFR 101.65(d) and other criteria laid out in a newly issued guidance document.

FDA explained in announcing this initiative late last month that:   Continue Reading Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food

Just MayoA bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those ingredients.  The goals of this and other standardized food definitions are to prevent economic fraud on consumers (and between supply chain partners), avoid unfair competition through false or misleading statements, and maintain the general quality of the country’s food supply.  In August, FDA reinforced to members of the food industry that long-standing regulations governing standardized foods exist for a reason and should be taken into account even when developing new and innovative products.

The Agency issued a Warning Letter to Hampton Creek Foods, Inc., an up-and-coming vegan food company that created “Just Mayo” – which uses canola oil instead of eggs and is marketed as an sandwich spread alternative to traditional mayonnaise, and which was launched in late 2013.  Just Mayo was cited for not meeting the standard of identity for mayonnaise products found at 21 C.F.R. § 169.140.  Specifically, FDA noted that: Continue Reading What’s in a Name? When You’re Selling a Food with an Established Federal Standard of Identity, a Whole Lot!