Regulatory & Compliance

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Rolled newspaper with the headline Changes in legislation

Slack fill litigation can be frustrating for businesses – at times even infuriating. For companies yet to find themselves on the wrong side of a slack fill lawsuit, the claim often boils down to, “I thought there was more in the package even though the label said exactly what I was buying.” Slack fill claims have proliferated in recent years, driven in large part by how easy it has been for class action plaintiffs’ lawyers to plead a claim that will at least survive to the discovery phase – the expense of which causes many businesses to settle even frivolous cases. Yet in a rare breath of fresh air, Governor Jerry Brown recently signed California Assembly Bill 2632, which will amend California’s slack fill statutes to give companies a new tool for avoiding slack fill claims.…
Continue Reading Three Slack Fill Regulatory Changes for Manufacturers to Watch

As the partial federal government shutdown enters its second week, businesses both large and small should be aware of the shutdown’s implications for the U.S. Consumer Product Safety Commission (CPSC) and for product safety. Companies should be aware that their obligations under CPSC continue, despite that their partner in product safety is absent until its funding is restored.
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Continue Reading Four Things You Should Know to Navigate the CPSC Shutdown

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

Blank Danger And Hazard Triangle Warning Sign Isolated Macro

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

Liquid soap, isolated

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?

Gavel and money

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

Toxic

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

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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.

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

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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

The one red

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