The U.S. Food and Drug Administration (FDA) has banned the import of genetically engineered (GE) salmon just two months after deeming AquaBounty Technologies, Inc.’s AquAdvantage® salmon safe for human consumption. Issued in compliance with the Fiscal Year 2016 Omnibus Appropriations Act, the January 29, 2016, import alert directs that “any shipment of suspected or known GE salmon or product composed in whole or in part of GE salmon should be promptly forwarded to the District Compliance Branch.” Although AquaBounty Technologies produces GE salmon at fish farms based in Canada and Panama, the company has not yet sold its product in the United States. But after FDA ruled that the salmon posed no environmental or human health risks, U.S. Sen. Lisa Murkowski (R-Alaska) moved to block confirmation proceedings for the next FDA commissioner until the agency required labeling for all products containing GE salmon. “This is a huge step in our…
Category Archives Food and Drug Administration
The Center for Science in the Public Interest (CSPI) has published a report criticizing the U.S. Food and Drug Administration’s (FDA’s) lack of action on food dyes. Titled Seeing Red: Time for Action on Food Dyes, the report points to studies allegedly linking food-dye consumption to behavioral issues in children—particularly those diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD)—concluding that FDA “has failed to protect or even inform consumers of the risks of dyes to children.” “We estimate that over half a million children in the United States suffer adverse behavioral reactions after ingesting food dyes, with an estimated cost exceeding $5 billion per year, using information cited by the U.S. Centers for Disease Control and Prevention and a recent meta-analysis sponsored by an arm of the food industry,” states CSPI. “A study of food labels in one supermarket found that more than 90 percent of child oriented candies, fruit-flavored snacks, and…
The U.S. Food and Drug Administration (FDA) has extended from February 16 to February 22, 2016, the comment period regarding requirements for fermented and hydrolyzed foods or those containing fermented or hydrolyzed ingredients that carry the “gluten-free” claim. The proposed rule would apply to foods such as sauerkraut, yogurt, pickles, cheese, green olives, vinegar, and FDA-regulated beers. Intended to address the uncertainty of interpreting test methods in terms of intact gluten, the finalized rule would mandate manufacturers to maintain records demonstrating: (i) “the food meets the requirements of the gluten-free labeling final rule prior to fermentation or hydrolysis”; (ii) “the manufacturer has adequately evaluated its process for any potential gluten cross-contact”; and (iii) “where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.” The agency also intends to evaluate the compliance of distilled…
A South Carolina federal court has ruled that the U.S. Food and Drug Administration (FDA) was not negligent in issuing a tomato recall during a 2008 outbreak of Salmonella, dismissing a tomato farm's claim of $15 million in damages. Seaside Farm Inc. v. U.S., No. 11-1199 (D.S.C., order entered December 16, 2015). The farm had argued that FDA should have been more specific in its recall, while FDA argued it never issued an official recall, only warnings about tomatoes. The court had previously dismissed allegations of defamation and takings against the government. Issue 588
The U.S. Food and Drug Administration (FDA) has published its annual report of sales and distribution data for antimicrobial drugs used in food-producing animals. The report’s analysis of 2014 statistics and observed trends of rising antibiotic use immediately drew the ire of consumer advocacy coalition Keep Antibiotics Working (KAW). “The data released today shows us that, despite industry assurances to the contrary, the use of human antibiotics on the farm have continued to rise, and specifically the use of the critically important antibiotic class cephalosporins (12% increase from 2013 through 2014), which the FDA placed restrictions on in 2012,” a KAW policy analyst said. KAW condemns industry’s voluntary cutbacks and calls for FDA to establish mandatory reduction goals. “FDA must set clear targets for the reduction in antibiotic use,” according to KAW. “Otherwise, industry will continue to conduct business as usual, while the crisis of resistance continues to loom large…
The U.S. Food and Drug Administration (FDA) has reportedly reached a deal with Hampton Creek, maker of eggless spread Just Mayo®, allowing the company to keep the name of its product but requiring changes to its packaging. Just Mayo® labels will now feature larger words touting its features, including "egg-free" and "spread and dressing," and a definition of "just" as "guided by reason, justice, and fairness." The product has been the target of litigation in recent years, including a lawsuit by competitor Unilever and a putative class action, because of the alleged misrepresentation of the product as mayonnaise despite its noncompliance with FDA’s standard of identity for mayo, which requires the inclusion of eggs. Hampton Creek was also allegedly the target of a smear campaign by the American Egg Board. Additional details appear in Issue 578 of this Update. Issue 588
The Center for Food Safety and the Seikatsu Club Consumers Cooperative have joined to jointly decry the U.S. Food and Drug Administration’s (FDA’s) recent determination that genetically engineered (GE) salmon produced by AquaBounty Technologies, Inc. is as safe to eat as conventional salmon and will have little effect on the environment. At the time of FDA’s announcement, the Center for Food Safety vowed to file a lawsuit against the agency. “FDA’s decision to approve this GE salmon was irresponsible and unlawful and it will have global repercussions,” said George Kimbrell, a Center for Food Safety attorney. “We are honored to join with our colleagues in Japan in opposing GE fish and the Aquabounty salmon. Together, we will work to stop its expansion in order to preserve our native fisheries and protect the markets so many depend on around the world.” According to the consumer groups, Japan imported $2 billion worth…
Environmental activist Erin Brockovich uses the U.S. Food and Drug Administration’s (FDA’s) recent determination that genetically engineered salmon is safe for human consumption and requires no labeling as such to rally consumers into action against genetically modified organisms (GMOs) in a December 1, 2015, opinion piece in Time. “The biotech industry and the FDA have hijacked not only our basic rights as consumers, but also our fundamental human rights in the face of corporate monopolization of our food supply,” Brockovich said. “They are jeopardizing our health and the environment more than ever before. When will the government agencies put in place to protect us stop servicing the bottom line of corporations?” Brockovich briefly reviews the findings of various agencies and organizations worldwide, ultimately imploring readers to “help spark a larger conversation about the food we are eating in this country” by voicing their GMO-related concerns to federal lawmakers. Issue 586
Kind LLC has filed a citizen petition to the U.S. Food and Drug Administration (FDA) challenging regulations governing the use of “healthy” on food labeling, arguing that specific nutrient levels in a product do not dictate whether it is “healthy.” The petition asks FDA to reevaluate its nutrient content claim regulations for consistency with current federal dietary recommendations and issue rules accordingly. Kind filed the petition months after FDA issued the company a warning letter—and the company was targeted by a consumer class action on the same subject—about the use of “healthy” on Kind snack bars, which contain more than 1 gram of saturated fat due to their nut content. Additional details about the letter and subsequent lawsuits appear in Issues 562 and 575 of this Update. Issue 586
The National Advertising Division (NAD), an investigative unit of the U.S. advertising industry’s system of self-regulation, has referred to the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) an ad campaign for Danisa “Traditional Butter Cookies,” which are manufactured by the Mayora Group in Indonesia and distributed by Takari International, Inc. NAD evaluated the campaign in April 2015 after Campbell Soup Co. challenged several aspects of the product’s marketing, including the claim that the cookies are “produced and packed in Denmark” and “baked following the original recipe from Denmark,” as well as the use of Scandinavian imagery. Further, Campbell argued that FDA requires any product labeled as “Butter Cookies” to use only butter as a shortening ingredient, but multiple independent studies have shown the presence of a non-butter fat ingredient in the Danisa product. Takari International argued it could not be liable for packaging claims or discrepancies…
