As we reported on previously (see here and here), FDA recently tussled with the manufacturer of an innovative vegan condiment called “Just Mayo” based on the existence of a Federal standard of identity for mayonnaise that requires the food product to incorporate eggs.

Similar disputes related to identity standards that don’t accommodate plant-based versions of foods, or that just don’t allow for new or innovative uses of traditional ingredients, seem to have increased in frequency and visibility over the past year. As a result, we expect that FDA is feeling pressure from diverse stakeholder groups to revisit some of its regulations and policies related to enforcing food standards of identity (SOI). This post highlights some of these emerging disputes and the trend of interested parties raising more challenges to long-standing (but potentially obsolete) food identity standards. Continue Reading Food Identity Disputes Continue to Impose High-Profile Pressure on FDA

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 First, it has extended the comment period that was initiated in October with the release of the draft guidance document until April 26, 2017.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

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed unanimously by the committee last month, the bill would give FDA marching orders to mandate the labeling of genetically engineered (GE) salmon, while putting the brakes on the agency’s labeling rules for restaurant menus.

The labeling requirement for GE salmon came via an amendment from Senator Lisa Murkowski (R-AK). Murkowski, who proposed the amendment twice before, has been at odds with FDA ever since it approved the use of GE salmon as human food, a move that she said could threaten “Alaska’s gold-standard reputation” for wild-caught salmon.

At the committee markup, she said mandatory labeling would not correct FDA’s “wrong-headed decision,” but it would allay some consumers’ concerns about the fish’s safety. The amendment, along with another that would restrict the labeling of Alaskan king crab to only crabs caught off Alaska’s shores, passed the committee on a voice vote.

At the markup, nary a word was said about the bill’s provision that would again delay FDA’s implementation of rules requiring chain restaurants include nutritional information on their menus.  The language in the Senate’s funding bill would effectively delay implementation until at least April 29, 2017.  The provision had been a long-time coming, given the broad bipartisan support for delaying or scrapping the menu labeling regulations. Most recently, the 2016 Omnibus Spending Bill, enacted last December, Congress delayed the compliance date for restaurants for one year, which FDA has interpreted as being one year after it issues a Final Guidance to assist affected industry in revising their menus to meet the new requirements.  So far, that final FDA guidance has not been issued so a future enforcement date has not been announced.

Whether either chamber plans to undo the menu labeling rules after an additional implementing delay remains to be seen; that legislative outlook could very well depend on the outcome of this year’s presidential election.

The Senate’s bill allots $2.76 billion in discretionary funding to FDA, an increase of $39 million over its FY 2016 enacted level. Along with the House’s version (H.R. 5054), which that chamber’s appropriations committee passed in April, the Senate’s measure now awaits a floor vote.

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized FDA guidance on use of the term “evaporated cane juice” (“ECJ”) as an ingredient in food labels may change things.  Specifically:

FDA’s present view is that “such sweeteners should not be declared on food labels as ‘evaporated cane juice’ because that term does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups) . . . .  Moreover, the use of ‘juice’ in the name of a product that is essentially sugar is confusingly similar to the more common use of the term ‘juice’ – ‘the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree’ (21 CFR 120.1(a)).  Thus, the term ‘evaporated cane juice’ is false or misleading because it suggests that the sweetener is ‘juice’ or is made from ‘juice’ and does not reveal that its basic nature and characterizing properties are those of a sugar.”

Continue Reading FDA Finally Decides that “Evaporated Cane Juice” Is Misleading Consumers

As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food – the Agency asked what types of processing make that claim misleading, or does the food have to be completely unprocessed?  Does natural connote “healthy” and is it confused with “organic” and should it be associated only with certain nutritional benefits?  And a host of other questions intended to help the Agency determine whether it can (or will) take the next step towards establishing a regulatory definition of “natural” on food products.  Tuesday May 10th was the last day to submit comments to FDA’s Natural Docket – now closed, this docket is indicating that it received over 7,600 individual comments.  So it will not be a small task for the Agency to review and consider all of those thousands of comments – but they’ve already decided to wade into another complex and important food claim, in this case the claim “healthy.” Continue Reading Just as the Comment Period for “Natural” Ends, FDA Announces Intent to Re-Examine What It Means to Be a “Healthy” Food

On July 1, 2016, Vermont’s Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE).  Unless Congress acts with unusual swiftness to pass federal legislation regarding GE or “GMO” food labeling that preempts conflicting state or local laws, Vermont’s law will result in the beginning of patchwork legislation among the states on this issue.  The effect of such legal patchwork will likely lead to confusion among consumers and manufacturers alike – and has forced food manufacturers to grapple with the question of whether to change the labeling for all their nationally distributed products to comply with Vermont’s law or to switch to non-GE food ingredients to avoid having to comply at all.  Among other things, manufacturers are concerned that compliance will significantly increase the costs of production, which will be passed on to consumers.

Law360 recently featured an article written by my colleagues Joanne Hawana and Benjamin Zegarelli  regarding the sudden urgency surrounding GE labeling.  The article provides a great overview of the current GE labeling state of affairs.  You can check it out here.

In the wake of the Senate’s defeat of legislation that would have preempted state-mandated GE ingredient labeling on food products, a new trend is emerging, as one food manufacturer after another announces that they will voluntarily label bioengineered ingredients contained in their national food product lines.  The chain reaction began less than two weeks ago, with General Mills’s announcement that it will label all its products in compliance with Vermont’s law.  That announcement was followed by similar statements from Mars and Kellogg’s last Monday and by ConAgra Foods the following day. Continue Reading Post-Senate Vote, Major Food Manufacturers Choose to Label Genetically Engineered Foods

genetically engineered food labelingThe latest salvo in the legislative food fight over genetically engineered (GE) ingredients came from the Senate, where Agriculture Committee Chairman Pat Roberts (R-KS) has introduced a bill that would instruct the Secretary of Agriculture to create a voluntary food labeling standard for bioengineered foods. Perhaps most importantly, this voluntary federal standard would preempt conflicting state laws, including Vermont’s that requires GE labeling starting on July 1st of this year. Roberts’s bill also proposes that the Secretary launch an educational campaign touting the economic, nutritional, humanitarian, and scientific benefits of biotechnology. Although the bill is still in draft form, it’s slated for an Ag Committee mark-up next week.

Shortly after the bill was introduced, it was swarmed with public comment from outside Congress. Continue Reading New GE Ingredient Labeling Bill Intensifies Food Fight in Congress