Tag Archives: CLAIMS

FDA Commissioner Gottlieb indicates future of FDA’s role in defining claims such as “healthy”

As previously reported on this blog, the Food and Drug Administration (FDA) received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” – which has not changed since 1994 – to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  In September … Continue Reading

FDA Hints at Marijuana Health Claim Crackdown

As many of our readers may know, marijuana is listed as a Schedule I substance under federal law.  However, individual state laws do not always conform to the federal standard.  In eight states, the sale and possession of marijuana is legal for both medical and recreational use, and twenty-three states and the District of Columbia … Continue Reading

Ninth Circuit Neutralizers

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 absence of any formal regulatory definition or regime to govern the use of the term.  Similarly, food companies also have faced challenges related to the use of … Continue Reading

Fatty Acid Follow-Up

FDA issues guidance to help food companies comply with final rule for omega-3 fatty acid claims. In April 2014, FDA published a final rule prohibiting certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids:  docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); and alpha-linolenic acid (ALA).  In short, the rule eliminated a … Continue Reading

Gluten-Free Go-Round

FDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods. As previously covered on this blog, FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting … Continue Reading

“Grass Fed” Gone?

USDA’s Agricultural Marketing Service withdraws the standards for “grass fed” and “naturally raised” marketing claims The Agricultural Marketing Service (AMS) of the USDA provides the livestock and meat industries with an option to voluntarily have marketing claims covered by AMS standards verified by the USDA, and to identify such claims as “USDA Certified”.  AMS established standards … Continue Reading

Yogurt Fight Gets Messy

Chobani’s latest ad campaign targets ingredients in Dannon and Yoplait products Yoplait and Dannon have accused competitor Chobani of using false and misleading statements about their products in Chobani’s latest ad campaign.  In newspaper, television, and social media advertisements that began airing January 6, 2016, Chobani states that unlike its Simply 100 yogurt, Yoplait Greek … Continue Reading

Happy New(s) Year

We welcome our readership back with a wrap-up of recent news items of interest: Vermont authorizes independent organizations to provide “non-GM” verification In anticipation of the upcoming July 1, 2016 effective date for Vermont’s GM labeling requirements, the state Attorney General has authorized two independent organizations to provide verification that food has not been knowingly … Continue Reading

Grounds for ‘Gluten-Free’

FDA Proposes Rule on ‘Gluten-Free’ Requirements for Fermented, Hydrolyzed and Distilled Foods In August 2013, FDA issued a final rule on voluntary “gluten-free” food labeling.  The final rule defined “gluten-free” as meaning that the food either is inherently gluten free or does not contain an ingredient that is: a gluten-containing grain (e.g., spelt wheat); derived … Continue Reading

Naturally Modified

Food producer settles class action lawsuit involving “all natural” claims for cooking oil made from GM crops. Challenges to “natural” claims continue to proliferate in court rooms across the United States, with many cases targeting “natural” claims for products derived from genetically modified (GM) crops.  FDA’s informal policy is that “natural” means nothing artificial (including artificial … Continue Reading

The Nuances of “Natural”

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 of challenge.  FDA’s informal policy is that “natural” means nothing artificial (including artificial flavors) or synthetic (including all color additives regardless of source) has been included in … Continue Reading

Eye on the EU: Health & Nutrition Claim Regulation

European Commission publishes roadmap to evaluate regulation on health and nutrition claims. As part of its policy to promote “better regulation,” the European Commission recently announced its plan to evaluate two aspects of Regulation 1924/2006/EC on nutrition and health claims:  (1) nutrient profiles; and (2) the use of claims on plants and their preparations. To this effect, the Commission has … Continue Reading

Substantiation Showdown

Bayer prevails over FTC in case addressing claim substantiation for dietary supplements. In the dietary supplement advertising area, the Federal Trade Commission (FTC) takes enforcement action where companies lack “competent and reliable scientific evidence” to substantiate marketing claims.  In 2014, the FTC initiated civil contempt proceedings against Bayer related to claims for a probiotic supplement, alleging that the … Continue Reading

Made in America (even in California)

California abandons “zero-tolerance” approach to foreign content in products bearing “Made in USA” claims. As previously covered on this blog, a product may bear a “Made in USA”-type (MIU) claim in accordance with federal guidelines where “all or virtually all” of the product is made in the U.S.A.  In contrast, California’s MIU standard has been much stricter, … Continue Reading

Non-GMO News

NSF International announces new Non-GMO certification program. As the food industry knows, “Non-GMO” claims — i.e., claims advertising the non-use of genetic modification (GM) in food production — have become popular and desirable from a marketing standpoint, despite the lack of any clear regulatory definition or oversight of such claims.  The Non GMO Project has been … Continue Reading


Market research firm reports on “free from” trend in snack foods. For years, the food industry has been looking for ways to eliminate or reduce the production of foods that contain ingredients associated with negative consumer perception.  In recent examples, a nationwide restaurant chain promoted a “GM-free” and additive reduction campaign; a major food processor pledged … Continue Reading

FDA Burns Tobacco

FDA issues Warning Letters to three tobacco manufacturers regarding “additive-free” and “natural” claims. FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control … Continue Reading

“Local” News

“Local” claims could become latest trend in food labeling. For years, food marketers have relied on claims such as “organic” and “natural” to attract consumers in the marketplace.  “Non-GMO” claims also have become more popular of late.  The U.S. Department of Agriculture (USDA) administers the regulatory regime governing “organic” claims, but no consistent or clear … Continue Reading

GMO-Free? Ask USDA…

USDA creates new voluntary “non-GMO” certification option for industry. As the food industry is well aware, companies continue to confront the challenge of developing appropriate marketing claims to advertise the absence of genetically modified (GM) content in food products.  FDA has issued draft guidance on this topic dating back to 2001, but such guidance has not … Continue Reading

Plaintiff Paydays on Pause

Continuing a trend, “all-natural” settlement includes no consumer payout. As the food industry is well aware, numerous class action lawsuits continue to be filed in California and in other jurisdictions challenging the propriety of “natural” or “all-natural” claims for food products that contain processed ingredients and/or genetically modified ingredients. In its recent settlement of an … Continue Reading

Trans Fat Free

Ninth Circuit ruling shines spotlight on the “trans fat free” claim arena. A “nutrient content claim” is a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling.  As a general matter, FDA must authorize specific nutrient content claims.  For years, there has been debate … Continue Reading

Continuing Sagas

Additional state AGs join probe into supplement marketing. The New York Attorney General’s (AG) investigation into the marketing of allegedly misbranded herbal supplement continues to develop.  The investigation commenced with theissuance of cease-and-desist letters to major retailers, sparked a series of class action lawsuits, and then shifted focus to target supplement manufacturers and claim substantiation. AGs … Continue Reading

Caffeine Claim

Family sues over caffeine-related death. On March 6, 2015, the family of Logan Stiner, an Ohio teenager who died from cardiac arrhythmia and cardiac arrest after consuming pure powdered caffeine, filed a wrongful death suit under the Ohio Food & Drug Safety Act.  The suit names as defendants Amazon.com, six other companies involved in manufacturing, marketing, distributing and selling the … Continue Reading

NY AG Supplement Probe Deepens

NY investigation into herbal supplements extends to manufacturers. New York’s Attorney General (AG) recently issued cease-and-desist letters to major retailers, alleging the marketing of misbranded herbal supplements.  Originally, the investigation focused on the contents of specific products, but in recent weeks, the focus has shifted to the substantiation of claims being made for the supplements. … Continue Reading