Responding to a novel food application submitted pursuant to Regulation (EC) No 258/97, the European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA) has verified the safety of cow’s milk treated with ultraviolet (UV) radiation to extend its shelf life. According to the NDA, the UV treatment increased the milk’s D3 concentrations but not in amounts likely to exceed the tolerable upper intake levels established by EFSA for children ages 1–10 years, adolescents and adults. “UV-treated milk is comparable to non-UV-treated milk, except for the vitamin D3 content,” states the NDA opinion. “No adverse effects regarding the contribution of milk to nutrient intakes are expected from the consumption of UV-treated milk in substitution of non-UV-treated milk. The Panel considers that the novel food is not nutritionally disadvantageous.” Issue 590
Tag Archives vitamins and minerals
A Missouri federal court has granted a motion to dismiss a lawsuit against Source Naturals, Inc., maker of Life Force® multivitamins, alleging the company misrepresented the amount of vitamins and nutrients in the product on the label. Dougherty v. Source Naturals, Inc., No. 15-0574 (E.D. Mo., order entered December 8, 2015). The plaintiff argued her tests of the multivitamin showed that the nutrient content claims on the product packaging were false, amounting to a violation of the Missouri Merchandising Practices Act. The court disagreed, finding the plaintiff's testing did not meet the methodology mandated by the U.S. Food and Drug Administration (FDA). "Because Plaintiff has failed to allege she followed FDA testing protocols," the court found, "her state law claims that rely on a different methodology to demonstrate such labeling violations are inconsistent with the [federal Food, Drug, and Cosmetic Act] and are thus preempted." Accordingly, the court granted the…
The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has issued two scientific opinions deriving dietary reference values (DRVs) for iron and copper. After estimating whole-body iron losses and absorption values for men and women, the panel set the population reference intake (PRI) at 11 mg/ day for men and postmenopausal women; infants ages 7 to 11 months; children ages 7 to 11 years; and boys ages 12 to 17 years. It also established PRIs of 16 mg/day for premenopausal women; 13 mg/day for girls ages 12 to 17 years; and 7 mg/day in children ages 1 to 6 years. Due to the absence of biomarkers indicating copper status as well as limited data, the NDA Panel only defined adequate intakes (AIs) “based on mean observed intakes in several European Union (EU) countries, given that there is no evidence of overt copper deficiency in…
Two consumers have reportedly filed a putative class action against Welch Foods, Inc. and Promotion in Motion Cos. alleging their Welch’s fruit snacks products are deceptively advertised as providing vitamins and nutrients despite being “no more healthful than candy.” Atik v. Welch Foods, Inc., No. 15-5405 (E.D.N.Y., filed September 18, 2015). Welch’s packaging advertises its products as produced from “real fruit” despite using only fruit concentrate, the complaint reportedly alleges, and the packaging implies the vitamins in the fruit snacks are derived from the fruit rather than introduced during the production process. This infusion allegedly runs afoul of the U.S. Food and Drug Administration’s “jelly bean rule,” which targets products that would not otherwise meet the agency’s standards for healthful foods without the addition of vitamins during the production process. See FoodNavigator-USA, September 23, 2015. Issue 580
A Florida federal court has denied the state’s motion to dismiss a First Amendment lawsuit challenging regulations that require products labeled as “skim milk” to contain the same amount of vitamin A as whole milk. Ocheesee Creamery, LLC v. Putnam, No. 14-621 (N.D. Fla., order entered February 7, 2015). Because the process of skimming cream from milk removes much of the vitamin A content, the regulation requires skim milk to contain added vitamin A to bear the “skim milk” label; otherwise, it must be labeled as “imitation milk product.” Ocheesee Creamery’s November 2014 complaint claimed that by refusing to allow the company to sell its pasteurized skim milk with a “skim milk” label unless it added vitamin A—which the creamery views as tainting its “all-natural” products—Florida is censoring its use of the phrase “skim milk.” In its motion to dismiss, the state argued that the creamery had no standing and failed…
The U.S. Food and Drug Administration (FDA) has amended food additive regulations pertaining to the safe use of vitamin D3 in response to a petition from Abbott Laboratories. The company requested that FDA approve use of the fat-soluble hormone “as a nutrient supplement at levels not to exceed 500 IUs per 240 mL in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that that the total amount of vitamin D3 provided by the product does not exceed 1,000 IU per day, and at levels not to exceed 1.0 IU per kilocalorie in food represented for use as a sole source of nutrition for enteral feeding.” Objections to FDA’s approval of Abbott’s petition or requests for a hearing must be filed by September 11, 2014. See Federal Register, August 12, 2014. Issue 534
The Environmental Working Group (EWG) has released a June 2014 report claiming that the fortification of foods with large amounts of vitamins and minerals could pose a health risk to children. Citing a study by the National Institutes of Health and California Polytechnic State University, EWG alleges that children younger than age 8 “are at risk of consuming vitamin A, zinc and niacin at levels above the Institute of Medicine’s Upper Intake Level.” According to the report, excessive intake of these nutrients could lead to liver and skeletal issues and immune system dysfunction, as well as short-term effects such as rash, nausea and vomiting. Targeting “two food categories that are frequently fortified and heavily marketed to children,” EWG’s analysis of 1,556 cereals and 1,025 snack bars allegedly identifies (i) “114 cereals fortified with 30 percent or more of the adult Daily Value for vitamin A, zinc and/or niacin,” and (ii)…
The U.S. Food and Drug Administration (FDA) has rejected objections filed after publishing its final rule amending “the food additive regulations authorizing the use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food.” According to the agency, “the objections do not provide any basis for us to reconsider our decision to issue the final rule,” and thus FDA has made no changes to it. See Federal Register, March 11, 2014. Issue 517
Following an application to claim that vitamin D is important to normal bone and teeth development in infants and children, the European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies has issued an opinion affirming that vitamin D contributes to normal development of bones and teeth. The panel noted previous favorable assessments of vitamin D and the maintenance of normal bones and teeth in the general population, concluding that “the role of vitamin D in bone and tooth mineralisation and homeostasis applies to all ages, including infants and young children (from birth to three years).” Issue 515
The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA) has launched a public consultation for its draft scientific opinion on dietary reference values for iodine. Using data from “a large epidemiological study in European school-aged children showing that goiter prevalence is lowest for a urinary iodine concentration ≥ 100 μg/L,” NDA has proposed setting adequate intake (AI) levels for iodine at 150 μg/day for adults and between 70 μg/day and 130 μg/day for infants aged 7-11 months and all children. The panel has also recommended an AI of 200 μg/day for pregnant and lactating women, which takes into account “the additional needs due to increased maternal thyroid hormone production and the iodine uptake by the fetus, placenta and amniotic fluid” as well as “the existence of large iodine stores in conditions of adequate iodine status before pregnancy.” EFSA will accept comments on the draft scientific…
