The Food and Drug Administration (FDA) has issued final rules amending food additive regulations pertaining to the use of ionizing radiation in the production, processing and handling of meat and poultry products. Promulgated at the request of the U.S. Department of Agriculture, the rules took effect on November 30, 2012. FDA requests written objections or requests for a hearing by December 31. The meat-product irradiation amendment would “provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life.” The poultry-irradiation amendment would “increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has proposed revoking “the standards of identity for artificially sweetened jelly, preserves and jam,” concluding that these standards “are both obsolete and unnecessary in light of [] regulations for food named by use of a nutrient content claim and a standardized term.” Responding to a citizen petition submitted by the International Jelly and Preserve Association (IJPA), the proposed rule notes that standards implemented in 1959 for fruit spreads containing nonnutritive sweeteners (NNSs) only provided for the use of saccharin, sodium saccharin, calcium saccharin, or any combination thereof (21 CFR 150.140 and 150.160). These standards did not include other NNSs approved for food use since 1959, although FDA later established under the Federal Food, Drug and Cosmetic Act a general standard of identity for foods named by a nutrient content claim such as “low calorie” or “sugar free” “in conjunction with a standardized food term,”…
The Food and Drug Administration (FDA) has issued a proposed rule that would update tolerances “for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style.” According to FDA, the regulations describing how to set animal drug tolerances for human food are not uniform, do not provide all relevant information, and “no longer accurately reflect current regulatory science.” “For example, the regulations provide the ADI [acceptable daily intake] and safe concentrations for some, but not all, drugs,” states the proposed rule. “In addition, the regulations list some tolerances as being for ‘negligible’ residue, and others as ‘no residue,’ ‘zero’ or ‘not required,’ but they do not explain what these important terms mean. The proposed rule addresses these inconsistencies by simplifying and standardizing the determination standards and codification style and by adding definitions for key terms.” FDA will accept…
The Food and Drug Administration (FDA) has suspended operations at nut and seed spread manufacturer Sunland Inc.’s New Mexico plant after investigators reportedly discovered Salmonella-tainted peanut butter linked to an outbreak that has allegedly sickened 41 people in 20 states this year. According to FDA, “the fact that peanut butter made by the company has been linked to an outbreak . . . coupled with Sunland’s history of violations led [the agency] to make the decision to suspend the company’s registration.” In a November 26, 2012, letter to Sunland’s president, FDA Commissioner Margaret Hamburg said evidence the agency collected in response to the outbreak demonstrated that “[n]ut butter and nut products manufactured, processed, packed, and held by your facility are contaminated with salmonella, or are at risk for contamination with salmonella, based on the conditions in your facility. Your facility’s testing records over the past 3 years include multiple positive…
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…
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 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…
Public Employees for Environmental Responsibility (PEER) has posted to its website documents relating to the use of antimicrobial drugs in livestock feed received from the Food and Drug Administration (FDA) under a Freedom of Information Act request. According to PEER, internal memos show that FDA is not, as the agency has claimed, working successfully with industry to phase out this use of antimicrobials, estimated at 30 million pounds in feed troughs annually. PEER claims that “70,000 Americans die each year from drug-resistant infections” and that the “rise of drug-resistant ‘super diseases’ is driven by overuse and misuse of antimicrobial drugs in livestock feed primarily to promote livestock growth.” In litigation, FDA defended its failure to timely follow through on proceedings to withdraw from use two antimicrobials by claiming that it had abandoned formal rulemaking in favor of more effective voluntary measures. Details about a court order requiring that FDA initiate…
