Category Archives Legislation, Regulations and Standards

Citing research studies alleging links between exposure to bisphenol A and various adverse health effects, U.S. Sens. Dianne Feinstein (D-Calif.) and Patrick Leahy (D-Vt.) have introduced the BPA in Food Packaging Right to Know Act. “Knowledge is empowering, and knowledge about BPA ingredients can also stimulate further reforms by the marketplace,” Leahy was quoted as saying. Among other things, the draft bill would require the secretary of the Department of Health and Human Services to conduct a safety assessment of low-dose, long-term exposure to BPA and any resulting potential negative health effects on vulnerable populations (e.g., pregnant women, children, senior adults) as well any potential adverse health effects on populations with high exposure to the chemical, such as workers involved in product manufacturing processes. The proposal would also mandate labels on food packaging containing BPA to carry the warning statement: “This food packaging contains BPA, an endocrine-disrupting chemical, according to…

The estate of Logan Stiner, an Ohio teenager who died in May 2014 after ingesting pure caffeine powder purchased from Amazon, has filed a lawsuit against the online retailer and the companies that manufacture and market the powder. Stiner v. Amazon.com Inc., No. 15CV185837 (C.P. Lorain Cty., filed March 6, 2015). According to the complaint, “pure caffeine is a drug” under Ohio law, but the powder manufacturers have “successfully avoided meaningful regulation of [the] product by the U.S. Food and Drug Administration (FDA) by classifying their product as a ‘dietary supplement,’” which leaves them “responsible for determining that pure caffeine powder is safe.” The companies “failed to alert users of the known risks and side effects of ingesting caffeine powder, including the risk of cardiac arrhythmia and cardiac arrest,” the reaction that killed Stiner, the complaint says. The estate also alleges that the companies did not conduct adequate testing of…

The World Health Organization (WHO) has recommended that adults and children reduce their daily intake of added sugars to less than 10 percent of their total daily energy intake. In addition, WHO calls for consumers to limit their consumption of added sugars to less than 25 grams (6 teaspoons) for further health benefits. The new advice follows the release of the U.S. Department of Health and Department of Agriculture’s proposed Dietary Guidelines for Americans, which would set similar limits for glucose, fructose and sucrose added to food and drink by manufacturers, retailers or consumers. “We have solid evidence that keeping intake of free sugars to less than 10% of total energy intake reduces the risk of overweight, obesity and tooth decay,” said Francesco Branca, director of WHO’s Department of Nutrition for Health and Development, in a March 4, 2015, press release. “Making policy changes to support this will be key…

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has extended the deadline for public comments on hazard identification materials on BPA and female reproductive toxicity from April 6 to April 20, 2015, in response to a request from the American Chemistry Council. OEHHA has also announced that the May 7 meeting of its Developmental and Reproductive Toxicant Identification Committee (DARTIC) to consider the addition of bisphenol A (BPA) to its list of chemicals known to the state to cause reproductive toxicity will be continued on May 21 in the same location if the committee is unable to finish its deliberations on May 7. Citing the availability of new epidemiological and toxicological data, DARTIC will assess “whether BPA has been clearly shown by scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.” After adding BPA to the list of reproductive toxicants under the Safe…

The U.S. Department of Agriculture’s Agricultural Marketing Service is hosting an April 27-30, 2015, public meeting of the National Organic Standards Board (NOSB) in La Jolla, California. The event will serve as NOSB’s final review of substances with sunset dates in 2016, and sessions will include those covering reports from the Materials, Livestock, Crops and Handling subcommittees. The tentative agenda, relevant proposals and information about the comment submission and meeting registration process are available here; the deadline for submitting written comments or registering to make oral comments at the meeting is April 7. See Federal Register, March 12, 2015.   Issue 558  

U.S. Sen. Charles Schumer (D-N.Y.) has introduced legislation that would ban the production, sale, distribution or possession of powdered alcohol. Schumer sponsored a similar initiative in 2014, and introduction of the new bill comes on the heels of the Alcohol and Tobacco Tax and Trade Bureau’s March 10, 2015, approval of four labels for flavored Palcohol® products manufactured by Lipsmark LLC. “I am in total disbelief that our federal government has approved such an obviously dangerous product, and so Congress must take matters into its own hands and make powdered alcohol illegal,” Schumer said. “Underage alcohol abuse is a growing epidemic with tragic consequences and powdered alcohol could exacerbate this. We simply can’t sit back and wait for powdered alcohol to hit store shelves across the country, potentially causing more alcohol-related hospitalizations and God forbid, deaths.” See Press Release of Sen. Charles Schumer, March 12, 2015; The Hill, March 13,…

A California appeals court has affirmed a lower court’s ruling dismissing a putative class action alleging that Safeway misbranded its Lucerne-brand of Greek yogurt because U.S. Food and Drug Administration (FDA) regulations prohibit the use of “milk protein concentrate” (MPC) in foods labeled as yogurt. Tamas v. Safeway, Inc., No. RIC1206341 (Cal. Ct. App., 4th Dist., Div. 3, order entered February 23, 2015). The plaintiff argued that a 1981 FDA regulation determining yogurt’s “Standard of Identity” (SOI) dictated what ingredients are allowable in products sold as yogurt despite the agency’s stay of the regulation soon after it was issued. FDA promised to schedule a public hearing on the regulation but, as of January 2009, “due to competing priorities and limited resources, FDA has not held a public hearing to resolve these issues and the effective date for these provisions remains stayed. Therefore, these provisions were never in effect. Consequently, cultured milk…

The Technical University of Denmark’s (DTU’s) National Food Institute has rejected the European Food Safety Authority’s (EFSA’s) recent bisphenol A (BPA) assessment, claiming that the agency’s decision to set the tolerable daily intake (TDI) at 4 micrograms per kilogram body weight per day does not adequately protect consumers. After examining EFSA’s toxicological evaluation, National Food Institute’s researchers criticized the scientific opinion for not applying an appropriate uncertainty factor and failing to take into account animal studies allegedly showing the effects of BPA on reproductive health and neurological development. The National Food Institute has instead proposed a TDI of less than 0.7 µg/ kg bw/day to protect against “endocrine disrupting effects.” In particular, the scientists note that, according to EFSA, men and women at the highest exposure levels are currently exposed to more than 1 microgram of BPA per kilogram per day, “while children and teenagers are exposed to between 1.26 and…

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has announced its intent to list styrene as a chemical known to the state to cause cancer under the authoritative bodies listing mechanism of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Styrene is used in the manufacture of various consumer products, including polystyrene packaging, synthetic rubber and food containers. Two previous attempts to list styrene as known to cause cancer under Prop. 65’s Labor Code listing mechanism failed. The agency’s latest attempt relies on findings in the National Toxicology Program’s (NTP’s) 2011 Report on Carcinogens, which concluded that styrene is “reasonably anticipated to be a human carcinogen” based on studies showing that inhalation and oral exposure to the chemical increased the incidence of malignant and combined incidence of benign and malignant lung tumors in male and female mice. The National Research Council confirmed…

The U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service is soliciting public comment on its current list of select agents and toxins with the potential to pose a severe threat to animal or plant health or to animal or plant products. The agency’s biennial review and republication of the list is required under provisions of the Agricultural Bioterrorism Protection Act of 2002. Criteria for determining whether an agent or toxin is placed on the list include the (i) effect of exposure to the agent/toxin on animal or plant health and on the production and marketability of animal or plant products; (ii) pathogenicity of the agent/toxin and the methods of transference to animals or plants; and (iii) availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by exposure to the agent/ toxin. Comments should be submitted by April 28, 2015. See Federal Register,…

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