Citizens for Health has filed a citizen’s petition with the Food and Drug Administration (FDA) requesting that the agency amend its high fructose corn syrup (HFCS) regulations. The requested changes would require food producers (i) using HFCS, to identify its concentration f ructose on product labels (e.g., HFCS with 42 percent fructose would be labeled “high fructose corn syrup 42”), and (ii) manipulating the mount of fructose in HFCS “to a different concentration than a standardized blend of 42 or 55,” to also incorporate the concentration into he ingredient name (e.g., HFCS with 90 percent fructose would be labeled “high fructose corn syrup 90”). Citizens for Health also asked that FDA initiate enforcement actions against food companies using HFCS with fructose in amounts other than 42 or 55 percent because these are the concentrations FDA has apparently designated as generally recognized as safe. According to the petition, numerous online articles…
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has issued its “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” Comments may be submitted at any time, although the guidance, with nonbinding recommendations for complying with a final rule that took effect in September 2009, has incorporated comments submitted after the draft guidance was published. Presented in a Q&A format, the guidance addresses compliance dates, the egg rule’s coverage, definitions, Salmonella Enteritidis prevention measures, testing, sampling, and registration requirements. See Federal Register, August 21, 2012. Noting that Americans consume 242 eggs per capita annually, New York University Nutrition Professor Marion Nestle draws attention to the guidance in her blog and cites a recent Canadian study claiming an association between the consumption of egg yolks and plaque formation in coronary arteries. She suggests that we should not “be eating so many eggs,”…
The Food and Drug Administration (FDA) has issued a final rule that amends regulations about concentrations of compounds of carcinogenic concern in the diet of food-producing animals and residues of carcinogenic concern in specific edible tissues. The changes clarify certain definitions “to enable the Center for Veterinary Medicine to consider allowing the use of alternative procedures to satisfy the DES [Diethylstilbestrol] Proviso without requiring the development of a second, alternative, set of terminology.” The changes take effect September 21, 2012. Among other matters, the amendment will change the existing emphasis in 21 CFR Part 500 on “no significant increase in the risk of cancer to the human consumer” to an emphasis on “the specific 1 in 1 million risk of cancer to the test animals approach.” See Federal Register, August 22, 2012.
The Food and Drug Administration (FDA) has responded to Senator Dick Durbin’s (D-Ill.) letter requesting that the agency take regulatory action “to address the rising health concerns around energy drinks” purportedly containing high levels of caffeine and other ingredients such as taurine, guarana and ginseng. Among other matters, in its August 10, 2012, letter, FDA suggests that research to date shows that “even when the consumption of energy drinks is considered, most of the caffeine consumed [in the United States] comes from what is naturally present in coffee and tea.” For most healthy adults, according to FDA, caffeine intake up to 400 mg per day is not associated with untoward health effects. Additional details about Durbin’s letter appear in Issue 435 of this Update. FDA’s generally recognized as safe (GRAS) regulation for caffeine applies to cola-type beverages; the agency “has not challenged the use of caffeine in other beverages at…
A coalition of advocacy organizations has filed five complaints with the Federal Trade Commission (FTC) against companies including McDonald’s Corp., General Mills, Inc. and Doctor’s Associates, Inc., calling for an investigation into Websites they purportedly use to promote food and TV programs to children. According to the coalition, the food-related websites— HappyMeal.com, ReesesPuffs.com, TrixWorld.com, and SubwayKids. com—violate the Children’s Online Privacy Protection Act (COPPA) by encouraging children to provide their friends’ email addresses and create videos promoting branded products to send to their friends. According to the coalition, “tell-a friend,” or “viral marketing,” is profitable given the effectiveness of word-of-mouth advertising and the opportunity to create “lifetime customers.” The coalition is also requesting that FTC update existing COPPA regulations “to include data collection and storage of photographs online from children, as well as placement of cookies used for types of behavioral advertising.” Claiming that “several of the child-directed websites we…
A federal magistrate judge in New York has determined that the Food and Drug Administration (FDA) must begin proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes on the agency’s timeline, thus denying FDA’s request for a stay while the matter is pending on appeal before the Second Circuit. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided August 8, 2012). In June, the court determined that FDA arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of these proceedings. More information about the case appears in Issue 442 of this Update. The magistrate first ruled on the Natural Resource Defense Council’s (NRDC’s) motion to strike a document from the record; it was an Animal Health Institute statement “expressing general support for the FDA’s plans to reduce the non-therapeutic use of medically-important antibiotics in animal feed through a voluntary guidance…
The U.S. Department of Agriculture (USDA) has announced an August 27-28, 2012, meeting of its Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) in Washington, D.C. USDA Secretary Tom Vilsack has specifically asked the committee to report on the types of compensation mechanisms that could be used “to address economic losses by farmers in which the value of their crop is reduced by the presence of GE [genetically engineered] material(s).” The committee will also discuss eligibility standards for triggering these mechanisms as well as other actions that may be appropriate “to bolster or facilitate coexistence among different agricultural systems in the United States.” According to USDA, “AC21 consists of members representing the biotechnology industry, the organic food industry, farming communities, the seed industry, consumer and community development groups, as well as academic researchers and a medical doctor.” Members of the public who wish to the attend the meeting must register…
Turtle Island Restoration Network and the Center for Biological Diversity have filed a complaint for declaratory and injunctive relief in a federal court in California against the Food and Drug Administration (FDA) to force the agency to act on their June 2011 petition seeking to reduce the allowable level of mercury in seafood. Turtle Island Restoration Network v. Hamburg, No. 12-03884 (N.D. Cal., filed July 25, 2012). The organizations claim that while FDA had 180 days, or until December 17, 2011, to respond to the petition, “[t]o date, FDA has neither granted nor denied the petition and has taken no action to reduce human exposure to mercury from commercial fish.” They request a court order declaring that FDA has violated the Administrative Procedure Act and requiring the agency to issue a decision on their petition within 30 days. The plaintiffs contend that FDA’s current action level for mercury in seafood…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and U.S. Environmental Protection Agency (EPA) have announced the availability of a guideline “for conducting microbial risk assessment (MRA).” Intended for government risk assessors and other public stakeholders, the guidance seeks to promote transparency and consistency between the two agencies as they conduct risks assessments of food- and water-borne disease. According to a July 31, 2012, EPA press release, the MRA guideline for the first time “lays out an overarching approach to conducting meaningful assessments of the risks to Americans posed by pathogens in food and water.” The agency has also touted the measure as a way to improve the quality of data “collected by public health scientists charged with protecting Americans from pathogen-related risks in food and water.” “This guidance contributes significantly to improving the quality and consistency of microbial risk assessments, and provides greater transparency to stakeholders…
The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a final rule revising the National List of Allowed and Prohibited Substances with regard to the use of tetracycline, formic acid and attapulgite during the production and processing of organic crops and food ingredients. According to NOP, the most recent iteration of the National List permitted the use of tetracycline “for fire blight control only” in apple, pear and other organic fruit crops until October 21, 2012. The final rule has amended the National List to specify that the substance can be used to control fire blight in apple and pear crops only and to extend the expiration date until October 12, 2014. In addition, NOP has added formic acid to the National List “solely for use as a pesticide within honeybee colonies” to suppress infestations of Varroa mites and approved attapulgite, a substance generally regarded as safe by the…
