Natalie Rainer

Latest Articles

California’s Office of Environmental Health Hazard Assessment (OEHHA) has posted a fact sheet regarding styrene on its Proposition 65 warning website, also known as the Lead Agency Website. OEHHA listed styrene as a carcinogen under Proposition 65 on April 22, 2016, and on May 4, 2017, the state adopted a No Significant Risk Level (NSRL) for styrene of 27 µg per day. Despite stating that “the levels of such residual styrene in polystyrene food packaging materials…
The U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) has issued an FAQ for manufacturers concerning its bioengineered (BE) food labeling rule (formally known as the National Bioengineered Food Disclosure Standard (NBFDS)).  The final rule was issued in December 2018 and does not come into effect for several years, but questions are being raised by industry regarding its obligations under the rule. For example, BE labeling is not required if you are processing food using a “validated…
Criticizing the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) for lack of oversight over foods produced with gene editing technology (e.g., Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9), the Center for Science in the Public Interest (CSPI) is calling for a federal registry of all gene-edited agricultural crops. CSPI is not requesting a registry of genetically-modified (GM) agricultural crops, which CSPI notes are subject to government oversight under 7 CFR Part…
FDA has accepted a qualified health claim petition submitted by Danone North America on the ability of yogurt to reduce the risk of type 2 diabetes.  FDA is accepting comments on the petition until June 11, 2019. Danone is requesting FDA’s consideration of the following qualified claims: (1) “Eating yogurt regularly may reduce the risk of type 2 diabetes.  FDA has concluded there is limited information supporting this claim;” or (2) “Eating yogurt regularly may…
Given the increased prevalence of plant biotechnology to develop innovative foods, FDA is reminding industry of its voluntary consultation program to ensure the safety of and public confidence in plant biotechnology-derived foods.  FDA describes “plant biotechnology” as “certain methods scientists can use to introduce new traits or characteristics to a plant.” FDA has assisted in 184 voluntary consultations through this program since its introduction in 1995.  In encouraging industry to participate in the program, FDA…
A California plaintiff, who used Roundup on his 56-acre Santa Rosa property and alleged glyphosate caused his non-Hodgkin lymphoma, has been awarded $80 million by a jury in the U.S. District Court for the Northern District of California.  The docket of the case, Hardeman v. Monsanto Co. et al., is available here (subscription required).  This verdict is the second significant glyphosate judgment against Bayer-owned Monsanto, following on the August 2018 verdict that awarded a former…
The San Francisco City Attorney, in coordination with the City’s Board of Supervisors, announced on March 20, 2019 that it will introduce legislation to prohibit the sale and delivery of e-cigarettes in the City unless such products have been established as “appropriate for the protection of the public health” through the Food and Drug Administration (FDA) Premarket Tobacco Product Application (PMTA) process.  Notably, the City Attorney did not indicate any intention to prohibit the sale
On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored cigars, in an effort to curb youth smoking rates.  The compliance policy permits “deemed” tobacco products on the market when FDA’s Deeming Rule went into effect on August 8, 2016 to remain on the market until premarket applications are due. Commissioner Scott Gottlieb stated, “Our proposal reflects a very careful public…
The European Food Safety Authority (EFSA) and the European Center for Disease Prevention and Control (ECDPC) have issued a joint summary report on antimicrobial resistance in the EU based on data from its 28 Member States. The 278-page report summarizes findings that antimicrobial resistance is increasing in bacteria that cause disease when transmitted from animals to humans (i.e., zoonotic diseases)—such as Campylobacter, Salmonella, and E. coli.  EFSA found that in some countries resistance of Campylobacter…
Following on recalls of dog food due to excess Vitamin D in late 2018, manufacturers are facing lawsuits by dog owners claiming their pets were injured by the products in question. According to FDA, analysis of the recalled dog foods by state and private labs indicate that the dog food contained as much as 70 times the intended amount of vitamin D, and all eight brands that were subject to the recall had been…