In response to a series of letters from Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.), Food and Drug Administration (FDA) officials have confirmed that the agency is currently reviewing the safety of energy drinks containing caffeine and other ingredients that act as stimulants and may require regulatory action if evidence of a health risk is found. Since April, both senators have urged FDA to take action to regulate energy drinks and to investigate the safety of ingredients with stimulant properties in combination with caffeine in energy drinks, particularly as they affect young consumers. In a recent press release, the senators note that “There is very clearly a lack of understanding about the health effects of energy drinks and their ingredients especially on children and adolescents,” and although they are glad to see that FDA is undertaking a review, more needs to be done and quickly. “For instance, FDA can and…
Category Archives U.S. Government and Regulatory Agencies
According to a November 5, 2012, New York Times article, technology and media companies have joined trade groups and marketing associations in opposing the Federal Trade Commission’s (FTC’s) efforts to update provisions implemented under the Children’s Online Privacy Protection Act (COPPA). As regulators look to expand the types of data-collection activities covered by COPPA, companies such as Facebook, Google and Twitter have reportedly pushed back against these proposals as unduly onerous and likely to stifle all web-based services created for children. Industry analysts have purportedly noted that once FTC requires parental consent for companies to use customer code numbers to track children, the agency “might someday require… similar consent for a practice that represents the backbone of digital marketing and advertising—using such code numbers to track the online activities of adults.” Furthermore, social media platforms have apparently taken issue with a plan to hold third parties liable “if they know…
The Food and Drug Administration (FDA) has issued a notice about a new system of records involving information collected from those required to submit user fees to the agency. The notice outlines the types of information collected relating to fees assessed under the Freedom of Information Act, Animal Drug User Fee Act, Animal Generic Drug User Fee Act, and Food Safety Modernization Act, among others. The notice also pertains to fees assessed under the authority of the Federal Food, Drug, and Cosmetic Act, such as “color additive certification fees and export certificate fees.” According to FDA, this information is unclassified and can be used for “routine purposes,” a term that FDA further elaborates in the notice. As FDA notes, “[t]he Privacy Act allows FDA to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the…
Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have reportedly called for a meeting with Food and Drug Administration (FDA) Commissioner Margaret Hamburg after reports surfaced that the agency has received adverse event reports indicating that the caffeinated energy supplement 5-Hour Energy® may have been linked to the deaths of 13 people in the past four years. The product has apparently been mentioned in 90 filings submitted to the agency; the reports include more than 30 that purportedly involved serious injuries such as heart attacks, convulsions and a spontaneous abortion. The senators have questioned the safety of energy drinks in three letters to the agency in recent months; their latest letter states, “[W]e request a meeting with you on the steps FDA is taking regarding highly caffeinated energy drinks and to ensure they are safe for their intended use and in combination with other energy drink ingredients.” The senators also…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued instructions for inspection program personnel (IPP) to follow “when verifying that large official establishments (with 500 or more employees) that produce meat and poultry products have prepared and are maintaining required written recall procedures.” According to FSIS, the notice complies with a May 8, 2012, final rule outlining requirements for notifying the agency of adulterated or misbranded products and maintaining written recall procedures. It also calls on IPP to remind large establishments “of the availability of food defense plan guidance because food defense plans also facilitate the removal of adulterated products from commerce.” Although food defense plans are currently voluntary, FSIS has stressed that their purpose is to help meat and poultry companies “respond to intentional contamination of products” and may be used with other recall systems. Written recall procedures, however, must “specify how the official establishment…
The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) has issued a final rule clarifying that the Organic Foods Production Act of 1990 and its implementing regulations require “periodic residue testing of organically produced agricultural products by accredited certifying agents.” Effective January 1, 2013, the rule also “expands the amount of residue testing of organically produced agricultural products by clarifying that sampling and testing are required on a regular basis [and] requires that certifying agents, on an annual basis, sample and conduct residue testing from a minimum of five percent of the operations that they certify.” See Federal Register, November 9, 2012.
Nutritionists and consumer groups have reportedly criticized the U.S. Department of Agriculture (USDA) for reducing its per capita sugar consumption estimate from approximately 100 pounds per year to 76.7 pounds per year. According to an October 26, 2012, New York Times article, Center for Science in the Public Interest (CPSI) Executive Director Michael Jacobson “stumbled across” the agency’s latest assessment “while working on a project on sugar consumption.” Lowering the previous benchmark by 20 percent, the revised numbers apparently raised red flags with Jacobson, who suggested that the methodology used by USDA researchers was “built on a foundation of sand.” “The new estimate is still relying heavily on experts making what seem to me to be largely guesses,” he told Times reporter Stephanie Strom. “Other than the 4 percent they’re getting [from the National Health and Nutrition Examination Survey], what do they really know for certain?” In particular, Strom questioned…
University of Wyoming College of Law Professor Mary Dee Pridgen has updated a treatise titled Consumer Protection and the Law to reflect recent developments in Federal Trade Commission (FTC) enforcement of its 1995 policy statement on food advertising. As she notes, although FTC and the Food and Drug Administration (FDA) have overlapping authority to police food advertising claims, they have generally divided their duties with FDA concentrating on food labels and FTC addressing advertising claims. FTC indicates in the policy statement that it will give advertisers “a bit more leeway in advertising than the FDA allows on labels,” but if an advertising claim complies with FDA labeling regulations, it will “generally be safe from FTC scrutiny.” Pridgen discusses FTC enforcement actions since the mid-1990s, involving Stouffer Foods, Häagen-Dazs, the Isaly Klondike Co., Mrs. Fields Cookies, Dannon, Gerber, and Kellogg, as well as companies that sell dietary supplements. She concludes, “In…
The Government Accountability Office (GAO) has issued a report recommending that the Food and Drug Administration (FDA) revise its approach when comparing foreign food safety systems with the U.S. system to better ensure the safety of imported food. Under the FDA Food Safety Modernization Act, FDA’s enhanced oversight of food imports includes express authority to implement a system for accrediting third parties like foreign governments and private auditing firms to certify foreign food facilities’ compliance with U.S. food safety requirements. The agency has apparently faced some challenges doing so. According to GAO, FDA has already started assessing selected foreign food safety systems to determine if they provide the same level of public health protection as domestic resources. But FDA has also stated “that it needs new approaches to improve its oversight of imported food that take into account the entire food supply chain and that it needs to push prevention…
U.S. Senators Richard Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have for the third time this year challenged the Food and Drug Administration (FDA) “to take immediate action” to address public concerns about energy drinks. In their October 26, 2012, letter to FDA, the senators write that they are “extremely concerned by reports of five deaths following the consumption of Monster energy drinks and a recent study showing that many energy drinks labels do not provide caffeine information to consumers.” Durbin and Blumenthal’s letter refers to a new study issued by Consumer Reports allegedly revealing that five of the 27 top-selling energy drinks contain caffeine at levels at least 20 percent above the listed amounts, with 11 beverages failing to specify caffeine content altogether. “We do not know enough about the effect of caffeine on children and young adults, yet energy drinks are marketed directly to kids without the oversight that…
