Tag Archives: CLAIMS

FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

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On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies … Continue Reading

FDA Encourages Participation in Voluntary Plant Biotechnology Consultation Program and Revises Guidance on Voluntary Labeling of Foods Derived Plant Biotechnology

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Given the increased prevalence of plant biotechnology to develop innovative foods, FDA is reminding industry of its voluntary consultation program to ensure the safety of and public confidence in plant biotechnology-derived foods.  FDA describes “plant biotechnology” as “certain methods scientists can use to introduce new traits or characteristics to a plant.” FDA has assisted in … Continue Reading

California Jury Awards $80 Million Verdict in Glyphosate Case

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A California plaintiff, who used Roundup on his 56-acre Santa Rosa property and alleged glyphosate caused his non-Hodgkin lymphoma, has been awarded $80 million by a jury in the U.S. District Court for the Northern District of California.  The docket of the case, Hardeman v. Monsanto Co. et al., is available here (subscription required).  This … Continue Reading

FDA Takes Action on Dietary Supplements Claiming to Treat Alzheimer’s Disease and Other Serious Conditions

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FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act. The products in question include … Continue Reading

FDA Extends Deadline for Comments on Nutrition Innovation Strategy

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At the National Food Policy Conference in March 2018, FDA Commissioner Scott Gottlieb, M.D., announced the creation of the Nutrition Innovation Strategy (NIS).  The NIS is intended to improve public health by educating consumers and encourage innovation to expand the use of nutrition in reducing the instances and impact of chronic disease.  FDA held a … Continue Reading

Putative Class Action Challenge to Diet Dr. Pepper in California Fails for the Fourth Time

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The Federal District Court for the Northern District of California has granted Dr. Pepper/Seven Up, Inc.’s Motion to Dismiss (available for purchase here) in a putative class action originally filed in October 2017, which alleged that the marketing of Diet Dr. Pepper violated California’s False Advertising Law, Consumer Legal Remedies Act, and Unfair Competition Law, … Continue Reading

Is Pet Food the Next Front for “Natural” Lawsuits?

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A class action lawsuit has been filed against Rachel Ray’s Nutrish dog food brand, alleging that “natural” claims were false and misleading under state consumer protection laws, based on testing that showed the presence of glyphosate residues. Glyphosate, commonly known as Roundup®, is an EPA-approved herbicide that is used on food crops, including crops that have … Continue Reading

Groups Petition FSIS to Change “Product of the USA” Policy

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The Organization for Competitive Markets (OCM) and American Grassfed Association (AGA) have petitioned the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) to change its standard for making a “Product of the USA” claim on meat and meat products. Currently, FSIS allows the statement “Product of USA” if either (1) the country to which the product is … Continue Reading

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

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On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, … Continue Reading

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

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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

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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

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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

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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

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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?

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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

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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

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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’

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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

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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”

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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
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