Regulatory & Compliance

This summer President Obama signed a new federal law requiring food manufacturers to disclose information regarding genetically modified organisms (GMO). The new law is different from the 2015 proposed GMO legislation which restricted states from enacting GMO labeling laws but didn’t contain federal labeling requirements.

The law represents a compromise between consumer groups and food manufacturers: it gives consumers access to information, and manufacturers flexible means of compliance and the benefit of a uniform federal standard.

The federal law, titled The National Bioengineered Food Disclosure Standard, leaves many issues unsettled. Two areas are attracting the most attention: the law’s digital disclosure methods and the definition of bioengineered food. Continue Reading Federal GMO Disclosure Law Creates Uniform Standards for Food Manufacturers & Provides Options for Disclosure

After considering them for more than a year, California’s Office of Health Hazard Assessment (OEHHA) has finally issued new “Safe Harbor” warning regulations for Proposition 65. The new regulations intend to provide consumers “more specificity” about the chemical content of products sold in California.  They take effect on August 30, 2018 and are set forth in California Health and Safety Code sections 25600, et seq. Continue Reading California Releases New Prop 65 Warning Regulations

Earlier this month, the Food and Drug Administration (FDA) banned 19 chemicals found in antibacterial hand and body washes. Included in this list is triclosan, a widely used ingredient in antibacterial soap.

The FDA’s new rule has been in the works for nearly four decades. The FDA proposed its first triclosan regulation in 1978 but never moved forward. Then, in 2013, the FDA called for a re-evaluation of over-the-counter antibacterial products. It asked companies to conduct additional studies and provide information on the safety and effectiveness of their antibacterial products containing any of one of 22 different ingredients. Continue Reading Anti-Anti-Bacterials?

Airing dirty laundry. The CPSC has made public its internal dispute over civil penalties. On July 20, 2016, Consumer Product Safety Commission Chairman Elliot Kaye and Commissioner Robert Adler issued a joint statement addressing the diverging views among the CPSC commissioners over the agency’s recent settlements. The joint statement responded to other commissioners who had criticized CPSC’s higher civil penalty settlements. Continue Reading CPSC Chairman Attempts To Bridge The Divide, Signaling That Higher CPSC Civil Penalties Are Here To Stay

On June 22, 2016, President Obama signed the Lautenberg Chemical Safety Act into law.  The Act is the first significant change to the 1976 Toxic Substances Control Act in 40 years and amends the Environmental Protection Agency’s (EPA) methods for reviewing chemical substances before they are marketed and allowed to be used in consumer products.

The Act has several new key features: Continue Reading Toxic Substances Control Act Revised for the 21st Century

Calls for a government-led investigation of the potential negative health effects of crumb rubber turf are getting louder, and the Consumer Product Safety Commission is listening. Crumb rubber turf infill consists of black pellets of ground-up rubber, and it’s become increasingly popular in the construction of sports fields. Some are concerned, however, that crumb rubber turf may expose athletes to cancer-causing chemicals.

On Wednesday, January 27, CPSC chairman Elliot F. Kaye, in statements to a Florida television station, indicated that CPSC will investigate the potential risks of rubber turf.

Continue Reading Government Turf: Will the CPSC Investigate Rubber Infill?

It’s not very often that manufacturers and many environmental groups agree on a chemical safety regulation. But that’s what’s happening with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which passed the Senate late last week, and would reform the Toxic Substances Control Act (TSCA). Continue Reading Non-Toxic Reform: Senate Passes TSCA Revisions

On Monday, August 3rd, the Food and Drug Administration (FDA) approved the first 3D printed pill, signaling a new opportunity for drug makers and 3D printing technology.

Spritam, a medication for epilepsy, is manufactured by Ohio-based pharmaceutical company, Aprecia Pharmaceuticals.  This particular drug has already been on the market, but the new, 3D printed version, is designed to dissolve more rapidly than any other seizure medication.  This new design also allows for a high drug load to be delivered in a single dose, limiting the number of pills necessary.  The 3D printed design may be particularly helpful for children or other patients who have difficulty swallowing large pills.  By layering medication, 3D printing allows the creation of a more porous pill that can dissolve more quickly into liquid.  The pill should be available commercially early in 2016.  Continue Reading FDA Approves First 3D Printed Pill

On July 23, 2015, the U.S. House of Representatives passed legislation that would restrict state and local governments from regulating the use of genetically modified (GM) plants in food if that regulation affects interstate commerce.

The bill, H.R. 1599, passed in a 275-150 vote after the bill’s main sponsor, Rep. Mike Pompeo, R-Kan., claimed that the bill is in line with the “overwhelming” scientific evidence on the safety of GM foods.  Specifically, Pompeo said that “[p]recisely zero pieces of credible evidence have been presented that foods produced with biotechnology pose any risk to our health and safety.”  He further stated that “ it is not the place of government — government at any level — to arbitrarily step in and mandate that one plant product should be labeled based solely on how it is bred, while another, identical product is free of government warning labels.” Continue Reading The Safe and Accurate Food Labeling Act Restricts State and Local Government from Regulating GMO in Food

The Consumer Product Safety Commission (CPSC) has responded to the June 27, 2015 PL&MT Blog’s post Falling off the Fast Track: CPSC’s New “Stop Sale” Demand by Jonathan Judge.  The post was republished by the National Law Review and the CPSC’s comments can be found here.  The back-and-forth is very productive and enlightening.  This post contains Jonathan Judge’s reply to the CPSC’s response. Continue Reading CPSC Engages in Productive Discussion Following PL&MT Blog Post on Fast Track Program