The Food and Drug Administration (FDA) has issued a report as part of a transparency initiative offering eight draft proposals “to make FDA’s publicly available compliance and enforcement data more accessible and user-friendly.” Based on public comments, an initiative task force will recommend specific draft proposals for FDA Commissioner Margaret Hamburg to consider by January 31, 2012. In particular, the report recommends that FDA explore (i) “different ways to improve data quality and facilitate more timely data disclosure,” (ii) “how to present its compliance and enforcement data graphically and better utilize mobile web applications,” (iii) “whether posting additional data compilations or analysis… would increase transparency,” and (iv) “ways to better utilize social media.” FDA requests comments by December 2, 2011. See Federal Register, October 4, 2011.
Category Archives Food and Drug Administration
The Office for the Under Secretary for Food Safety, the U.S. Department of Agriculture and the Food and Drug Administration have announced an October 4, 2011, public meeting in Washington, D.C., to provide information and receive public comments on draft U.S. positions to be discussed at the 19th session of the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) on October 17-21 in Cairns, Australia. CCFICS is responsible for such things as “harmonizing methods and procedures which protect the health of consumers, ensure fair trading practices and facilitate international trade in foodstuffs.” Agenda items include relevant activities of the World Health Organization and draft guidelines for national food-control systems. See Federal Register, September 27, 2011.
A new Environmental Health Perspectives paper discusses a Food and Drug Administration (FDA) advisory committee’s recent conclusion that the evidence is too inconclusive to associate children’s consumption of artificial colors in food with hyperactivity or to recommend warning labels. Titled “Synthetic Food Colors and Neurobehavioral Hazards: The View from Environmental Health Research,” the paper suggests that if FDA had approached the issue from an environmental health perspective and broadened its inquiry to consider a range of adverse effects, current research findings could have supported a different outcome. The author notes that the review confined itself “to the clinical diagnosis of hyperactivity . . . rather than asking the broader environmental question of behavioral effects in the general population; it failed to recognize the significance of vulnerable subpopulations; it misinterpreted the meaning of effect size as a criterion of risk.” The article concludes that scientific risk reviews with “too narrow a…
WSJ Reporter Ashby Jones provides an overview of the recent spate of lawsuits challenging food makers’ claims that their products are “All Natural” or “100% Natural.” Without an official Food and Drug Administration (FDA) definition of the term, determining whether such product claims constitute fraud can be difficult, according to lawyers such as Center for Science in the Public Interest’s Stephen Gardner, who was quoted as saying, “We badly want them to provide some clarity on the issue, but they’ve repeatedly failed to do anything.” The article notes how FDA muddied the waters for products containing high-fructose corn syrup (HFCS) by announcing in 2008 that it is not “natural” and then later pronouncing that it actually depends on how synthetic ingredients are used to make the HFCS. Details about the FDA’s HFCS actions appear in Issues 255 and 266 of this Update. An FDA spokesperson acknowledged that the agency has…
Asserting that its technical animal drug-regulation amendment is not subject to congressional review, the Food and Drug Administration (FDA) has issued a final rule that increases the allowable residues of progesterone in edible tissues of cattle and sheep to reflect revised daily consumption values in a 1994 guidance document. According to the Federal Register notice, “Progesterone is approved for use in subcutaneous implants used for increased rate of weight gain in suckling beef calves and steers and in vaginal inserts used for management of the estrous cycle in female cattle and ewes.” The rule took effect on September 19, 2011, when it was published.
The Food and Drug Administration (FDA) recently issued a consumer update reassuring the public about the safety of apple juice after a TV talk show claimed that certain brands contain high levels of arsenic. Mehmet Oz, who hosts “The Dr. Oz Show,” apparently sent 50 apple juices samples to EMSL Analytical, Inc., which measured total arsenic levels as high as 36 parts per billion (ppb) in one sample. After learning of the results, FDA sent two letters to the show’s producers asking them not to air the segment, not only because the results seemed “erroneously high” but also because the laboratory only considered the total amount of arsenic. “As we have previously advised you, the results from total arsenic tests CANNOT be used to determine whether a food is unsafe because of its arsenic content,” stated FDA in its September 9, 2011, letter. “We have explained to you that arsenic occurs…
According to documents obtained by Associated Press reporter Thomas Watkins, the Food and Drug Administration (FDA), which is currently considering a Corn Refiners Association petition to allow high-fructose corn syrup (HFCS) to be called “corn sugar,” has written to the association indicating concern with the trade group using the terms interchangeably. In the July 12, 2011, letter, an FDA director reportedly stated, “We request that you re-examine your websites and modify statements that use the term ‘corn sugar’ as a synonym for (high fructose corn syrup).” On behalf of the association, Audrae Erickson reportedly stated, “We do not believe that anyone could be confused or believe that the statements regarding ‘corn sugar’ on the websites refer to anything other than high fructose corn syrup.” Watkins notes that FDA has no regulatory authority over the association’s advertising because it promotes an industry and not a product. The FDA letter apparently indicated…
The Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) have established new dockets “to obtain comments, data and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction.” FDA and FSIS have warned that current sodium consumption “is substantially higher than what has been recommended by scientific and public health agencies and organizations,” including the Institute of Medicine and the USDA in its 2010 Dietary Guidelines for Americans. According to the September 15, 2011, Federal Register notice, “The Centers for Disease Control and Prevention (CDC) reported in 2010 that over 80 percent of adults (>=20 years) recommended to consume less than 2,300 mg/d [milligrams per diem] of sodium in fact consumed more than 2,300 mg/d.” The new dockets invite stakeholders and other interested persons to provide information about (i) “current and…
According to a news source, Del Monte Fresh Produce NA Inc. has indicated, as part of its campaign to counter allegations that its cantaloupes, imported from Guatemala, were tainted with Salmonella, that it intends to sue the Oregon Health Authority and a public health official for making “misleading allegations” about its products. Company Vice President Dennis Christou reportedly said, “These statements were made despite the lack of a substantive factual basis for the allegations and the failure to adequately investigate the true source of the contamination.” Information about litigation Del Monte filed against the Food and Drug Administration (FDA), seeking to lift an import alert related to its Guatemalan cantaloupes appears in Issue 407 of this Update. The Center for Science in the Public Interest (CSPI) has criticized the company for taking action against government agencies, stating in a press release, “FDA and Oregon used state-of-the-art techniques to identify the food…
The Natural Resources Defense Council, Inc. (NRDC), a non-profit advocacy organization, has filed a complaint for declaratory and injunctive relief against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), seeking an order compelling FDA to issue a final response to NRDC’s October 2008 petition calling on the agency to prohibit the use of bisphenol A (BPA) in food packaging and other food-contact materials. NRDC, Inc. v. HHS, No. 11-5801 (S.D.N.Y., filed August 19, 2011). In June 2011, the D.C. Circuit Court of Appeals apparently dismissed a similar complaint, agreeing with FDA that it had been filed in the wrong court. Additional information about that complaint appears in Issue 356 of this Update. According to the new complaint, the Food, Drug, and Cosmetic Act requires FDA to respond to petitions like the one NRDC filed “within 90 days.” Yet, “ [m]ore than one thousand…
