The Food and Drug Administration (FDA) has issued a final rule amending 21 C.F.R. 175.300 to reflect the industry’s abandonment of bisphenol A (BPA)- based epoxy resins as coatings in infant formula packaging. As of July 12, 2013, the food additive regulations will no longer provide for this use of BPA. According to FDA, its action followed Rep. Edward Markey’s (D-Mass.) petition asserting that industry had stopped using BPA in infant formula packaging; the action “is not “related to the safety of BPA.” See FDA Center for Food Safety and Applied Nutrition—Constituent Update, July 11, 2013.
Tag Archives baby food
The European Parliament has reportedly passed legislation regarding the labeling and content of baby formula and other foods for special medical purposes. Included in the new rules, which reportedly take effect in 2016, is a ban on the use of images of babies on infant formula packaging. Specifically, the new rules state that the labeling, presentation and advertising of infant formula and follow-on formula (for babies ages 6 to 12 months old) must not include “pictures of infants, or other pictures or text which may ideali[z]e the use of such formula[]” in order “not to discourage breast-feeding.” Graphic representations intended for “easy identification of the formula and for illustrating methods of preparation” will evidently still be permitted. See European Parliament News Release, June 11, 2013.
The European Food Safety Authority (EFSA) has issued “a call for acrylamide occurrence data in food and beverages intended for human consumption collected outside official controls.” Part of the agency’s ongoing assessment of acrylamide levels in food and beverages, the latest request for data focuses on the following product categories: (i) french fries sold as ready to eat; (ii) potato crisps; (iii) pre-cooked french fries and potato products for homecooking; (iv) soft bread; (v) breakfast cereals; (vi) biscuits, crackers, crisp bread, and similar products; (vii) coffee and coffee substitutes; (viii) baby foods, “other than processed cereal based foods”; (ix) “processed cereal-based foods for infants and young children”; and (x) other products, including muesli and porridge, pastry and cakes, and savory snacks. EFSA has specified that “the analytical method used for the quantitative determination of acrylamide… should achieve a LOQ [level of quantification] of 30 µm/kg for bread and foods for…
The Food and Drug Administration (FDA) has issued a proposed rule that would add selenium to the list of nutrients required in infant formula as well as establish minimum and maximum levels for the mineral in this context. Under the proposed rule, which recognizes selenium as an essential nutrient, infant formula labels would also need to list the amount per 100 kilocalories of formula. According to FDA, the selenium content of soil varies widely by geographic region, leading to either chronic selenium toxicity or dietary deficiencies that can result in diseases such as cardiomyopathy. Recognizing that formula “is intended to be the sole source of nutrition for infants,” FDA has proposed “2.0 µm selenium/100 kcal as the minimum level for selenium in infant formulas and 7.0 µm selenium/100 kcal as the maximum level.” The agency will accept comments on the proposed rule until July 1, 2013. See Federal Register, April 16,…
According to a news source, trial begins April 8, 2013, in the Environmental Law Foundation’s Proposition 65 (Prop. 65) lawsuit against 28 food manufacturers and retailers in a California state court, alleging failure to warn the public that their baby and toddler foods and fruit juices contain lead, a chemical known to the state to cause reproductive toxicity or cancer. Envtl. Law Found. v. Beech-Nut Nutrition Corp., No. 11-597384 (Cal. Super. Ct., Alameda Cty., filed Sept. 28, 2011). Details about the case appear in Issue 412 of this Update. The trial will involve the manufacturing defendants and will resolve their affirmative defenses only. Trials over damages issues and claims against the retailers have not apparently been scheduled. Among the defenses that the court will consider are whether (i) Prop. 65, as applied, is preempted under the Food, Drug, and Cosmetic Act and federal nutrition programs; (ii) exposure to the products’ lead levels…
The Maine Department of Environmental Protection (DEP) has reportedly indicated its support of a state ban on the chemical bisphenol A (BPA) for infant formula packaging, but stopped short of suggesting that the chemical be prohibited from baby and toddler food containers, which environmental activists have been requesting. Maine already bans the chemical from baby bottles, sippy cups and reusable food and beverage containers, but, according to news sources, DEP officials claim that the scientific evidence is limited on whether the most common baby food containers—glass jars with metal lids that contain BPA—cause children to be exposed to the chemical. Agency officials are also apparently concerned about whether rules implementing the chemical ban would be sufficiently clear for consumers and companies to follow. News sources state that DEP is expected to make a recommendation on extending the BPA ban by the end of January 2013, and that an expanded ban…
The Judicial Panel on Multidistrict Litigation (JPML) has denied a motion to centralize, for pre-trial purposes, 10 lawsuits pending in five districts against Gerber Products Co. and Nestlé USA, Inc. alleging that the companies “misleadingly advertise and market infant formulas and cereals as promoting immunity, digestive health, and visual and cognitive function because they contain probiotic cultures” and other ingredients. In re Gerber Probiotic Prods. Mktg. & Sales Practices Litig., MDL No. 2397 (JPML, decided October 16, 2012). According to the court, five of the 10 lawsuits are already consolidated in the District of New Jersey where Gerber is headquartered. One of these cases was filed in California, “thus one transferor court already has concluded that under Section 1404 the District of New Jersey is the proper venue for this litigation.” Because the defendants filed section 1404 change of venue motions in the remainder of the cases, and if all…
According to Nestlé Australia, some consumers feeding their babies NAN H.A. [hypoallergenic] 1 Gold® infant formula have complained about alleged adverse health effects. A news source indicates that purchasers have reported in online reviews that their children have experienced rashes, dark green stools, dehydration, and vomiting, among other symptoms. Calling product safety and quality a “non-negotiable priority for the company” Nestlé, which has been testing the product, further states on its website that results “to date confirm there is no food safety issue.” The company apparently reformulated the product in 2011, replacing calcium chloride with potassium chloride to produce “a better taste and a smoother texture to the powder,” and otherwise improving its “nutritional profile.” See Nestlé News Release, August 8, 2012; FoodProductionDaily.com, August 9, 2012.
The Food and Drug Administration (FDA) has issued a final rule amending the food additive regulations at 21 CFR part 177 “to no longer provide for the use of polycarbonate (PC) resins,” including bisphenol A (BPA), in infant feeding bottles or spill-proof sippy cups. Effective July 17, 2012, the final rule apparently responds to a petition filed by the American Chemistry Council (ACC), which claimed that “that baby bottles and sippy cups manufactured from PC resins are no longer being introduced into the U.S. market and that manufacturers of baby bottles and sippy cups have abandoned the use of PC resins in making these products.” After reviewing the submitted data and seven public comments addressing the petition, FDA concluded that the use of PC resins in these products has been “completely and permanently abandoned,” and agreed to amend the regulations accordingly. The agency has requested objections to the final rule…
According to news sources, Philippine Department of Justice Secretary Leila de Lima issued an opinion in May 2012, upholding a Department of Health (DOH) memorandum that prohibited multinational companies that make infant milk and other nutritional products from using registered trademarks that contain health and nutrition claims which may undermine breastfeeding and breast milk. The companies were not prohibited from selling or advertising their products as long as their marketing materials, including product labels, comply with DOH rules. DOH apparently took the action on the basis of data showing that the country has a weak breastfeeding culture. In issuing her ruling, de Lima rejected the companies’ contention that preventing a trademark owner from the right to use its own registered mark on its products constituted a deprivation of property without due process of law. She reportedly said, “deceptive marks and misdescriptive marks are absolutely unregistrable.” See Business Mirror, June 13,…
