Posts By Shook, Hardy & Bacon L.L.P.

A GAO report has claimed that the Food and Drug Administration (FDA) “examined less than 1 percent of the 7.6 million fresh produce lines imported from fiscal years 2002 through 2007.” “Moreover, FDA acknowledged that it has not yet been able to conduct certain fresh produce work crucial to understanding the incidence of contamination of produce by pathogens such as E. coli O157:H7 or Salmonella,” according to GAO, which attributed the failures to a lack of resources for either extramural research grant programs or internal research agendas. The report also noted that the agency “has no formal program devoted exclusively to fresh produce” and has not “reliably tracked its fresh produce spending. “What I found most interesting is that fresh produce has been a priority for FDA for nearly a decade, but all the initiatives the agency said it needs to implement to improve its oversight efforts have been delayed because…

Country-of-origin labeling rules, long-delayed for fresh, perishable foods other than fish and shellfish, went into effect on September 30, 2008. They require supermarkets and mass-merchandise outlets to label or display the country of origin for meats, poultry, produce, and some nuts. Small food outlets, such as butcher shops and restaurants are exempt, and the rules do not apply to processed foods, like smoked salmon and cooked shrimp, or mixes, like bagged mixed salad greens, trail mix and fruit salad. Meats blended with products from several countries are not required to list the countries in any particular order. Any covered foods produced or packaged before September 30, do not have to include the COOL information. For many years, foods packaged in another country have been required to carry origin labeling; with the latest COOL implementation, almost all food should carry this information. Consumer groups have hailed the mandatory rule change, calling…

USDA has requested that the American National Standards Institute (ANSI) revoke the standards-development accreditation of the Leonardo Academy, the entity behind the development of a sustainable agriculture standard that was published as a draft standard for trial use in ANSI’s Standards Action in April 2007. Details about an initial stakeholder meeting held in November to discuss the draft standard appear in Issue 237 of this Update. USDA has also asked ANSI to withdraw the draft standard for trial use. In its September 2008 letter to ANSI, USDA contends that (i) the draft standard exceeds the scope of the academy’s approved scope of standards activities by straying into fair labor practices, community benefits, product quality, and product safety and purity; (ii) the academy failed to develop or publicize “its procedures with respect to draft standards for trial use”; (iii) the academy “failed to afford materially affected interests the opportunity to challenge…

FDA has issued a final rule “amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis.” Effective January 1, 2010, the rule would also eliminate (i) “the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis”; (ii) “the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis”; (iii) “the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional”; and (iv) “the requirement that the claim…

The Food and Drug Administration (FDA) this week issued the results of “its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant food.” Prompted by “reports of melamine contamination in milk-derived ingredients” manufactured in China, FDA reviewed its scientific literature on melamine toxicity, pointing to “gaps in our scientific knowledge” regarding the threshold at which the industrial chemical becomes dangerous in infants. “There is too much uncertainty to set a level in infant formula and rule out any public health concern,” according to an October 3, 2008, FDA press release, which noted that for other food products, “levels of melamine and melamine-related compounds below 2.5 parts per million do not raise concerns.” Meanwhile, U.S. officials have reportedly located more melamine-tainted candy from China in New Haven, Connecticut, where two specialty stores were selling the White Rabbit Creamy Candy brand implicated in the global dairy scandal.…

A California resident has filed suit against ConAgra Foods, Inc., alleging that it falsely advertises and labels its Healthy Choice® pasta sauce products as “100% Natural,” “Natural” or “All Natural” despite using high-fructose corn syrup (HFCS) to make them. Lockwood v. ConAgra Foods, Inc., No. 08-4151 (N.D. Cal., filed September 2, 2008). Claiming that “[t]he complicated process used to create HFCS does not occur in nature” and that “it is misleading to consumers to label products that contain HFCS as ‘Natural,’” the plaintiff seeks to certify a class of “All persons in California who purchased any of Defendant’s pasta sauce products containing High Fructose Corn Syrup, yet marketed, advertised or labeled as being ‘All Natural’, ‘Natural’ or ‘100% Natural’ during the ‘Class Period.’” According to the plaintiff, a number of common questions predominate over individual issues, including whether defendant misrepresented its ingredients, mislabeled its products or engaged in unfair and…

In a July 3, 2008, letter to the Corn Refiners Association, the FDA has indicated that products containing high-fructose corn syrup (HFCS) may be labeled “natural” if the synthetic fixing agent that is used in the HFCS production process does not come into contact with the high dextrose equivalent corn starch hydrolysate, which undergoes enzymatic reaction to produce HFCS. The fixing agent apparently holds the enzyme in place on a column and any unreacted agent is removed by washing before the starch hydrolysate is added. Thus, “we would not object to the use of the term ‘natural’ on a product containing the HFCS produced by the manufacturing process described” by a representative of the Archer Daniels Midland Co., who met with FDA at the request of the Corn Refiners Association in April 2008. The agency added, “we would object to the use of the term ‘natural’ on a product containing…

According to a news source, a federal court in New Jersey has dismissed claims that the manufacturer of a beverage containing high-fructose corn syrup (HFCS) deceived the public by promoting the product as “all natural.” The court apparently based its ruling on federal preemption, leaving it to the Food and Drug Administration (FDA) to define the terms “natural” and “all natural.” U.S. District Judge Mary Cooper reportedly stated, “This court will not determine that which the FDA, with all of its scientific expertise, has yet to determine, namely how the terms ‘natural’ and ‘all natural’ should be defined and whether either may be used on the label of a beverage containing HFCS. Instead, this court will allow the FDA, which has already set forth specific requirements for what must be included on beverage labels, to decide whether such a determination is necessary and warranted.” The ruling specifically applies to Snapple®…

Researchers at the John Hopkins Bloomberg School of Public Health have reportedly concluded that obesity may increase the risk of developing adult-onset dementia. Beydoun, M. A., Beydoun, H. A. & Wang, Y., “Obesity and central obesity as risk factors for incident dementia and its subtypes: a systematic review and meta-analysis,” Obesity Reviews, May 2008. The authors conducted a meta-analysis of 10 previously published studies examining the relationship between dementia or its subtypes and various measures of body fat. A pooled analysis from seven of these studies indicated that baseline obesity increased the risk of Alzheimer’s disease by 80 percent on average, according to the Bloomberg School of Public Health. In addition, researchers found that underweight participants were also at a greater risk of dementia or related conditions. “Our analysis of the data shows a clear association between obesity and an increased risk for dementia and several clinical subtypes of the disease,”…

An FDA administrator has reportedly told a media source that the agency “would object to the use of the term ‘natural’ on a product containing HFCS [high fructose corn syrup].” Food NavigatorUSA.com revealed in an April 2, 2008, article that its reporters had inquired about HFCS using an FDA system designed to assist manufacturers with the labeling process. According to Food Navigator, FDA Supervisor Geraldine June of the Office of Nutrition, Labeling and Dietary Supplements replied in an email that, “The use of synthetic fixing agents in the enzyme preparation, which is then used to produce HFCS, would not be consistent with our (…) policy regarding the use of the term ‘natural.’” “Moreover,” June added, “the corn starch hydrolysate, which is the substrate used in the production of HFCS, may be obtained through the use of safe and suitable acids or enzymes. Depending on the type of acid(s) used to obtain…

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