Category Archives: Regulatory & Compliance

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Federal GMO Disclosure Law Creates Uniform Standards for Food Manufacturers & Provides Options for Disclosure

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: … Continue Reading

California Releases New Prop 65 Warning Regulations

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 … Continue Reading

CPSC Chairman Attempts To Bridge The Divide, Signaling That Higher CPSC Civil Penalties Are Here To Stay

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 … Continue Reading

Toxic Substances Control Act Revised for the 21st Century

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. … Continue Reading

Government Turf: Will the CPSC Investigate Rubber Infill?

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 … Continue Reading

FDA Approves First 3D Printed Pill

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, … Continue Reading

The Safe and Accurate Food Labeling Act Restricts State and Local Government from Regulating GMO in Food

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 … Continue Reading

CPSC Engages in Productive Discussion Following PL&MT Blog Post on Fast Track Program

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 … Continue Reading

Falling off the Fast Track: CPSC’s new “Stop Sale” Demand

When a company sells a consumer product that poses a potential hazard to consumers, federal law requires that a report be filed with the U.S. Consumer Product Safety Commission (CPSC). 15 U.S.C. § 2064(b). Companies who fail to do so risk severe civil penalties. After the company’s report has been filed, the CPSC offers companies … Continue Reading

Scrutiny of Nail Salon Chemicals Raises Mass Tort Risk

Recent reports purport to link certain chemicals used in nail salon products to serious health problems such as cancer, asthma, respiratory disease, and miscarriages.  Though past efforts to impose stricter regulations on these chemicals have been largely unsuccessful, a recent slew of New York Times articles have drawn significant attention to the issue.  In response, … Continue Reading

UPDATE: FDA Speeds Up the BMPEA Battle

In response to mounting pressure, the FDA issued warnings to five supplement companies last week regarding the risks associated with beta-methylphenethylamine, or BMPEA. BMPEA is widely used in weight loss and energy supplements, but has an ingredient similar to amphetamine. Supplement makers claimed that BMPEA was allowed in dietary supplements because it occurred naturally in a shrub … Continue Reading

Grocery Freezers Empty as Blue Bell Conducts Massive Ice Cream Recall

Last night, Texas-based Blue Bell Creamery announced a full, nationwide recall of all its products. This is a significant expansion of the recall Blue Bell began earlier this month after three deaths in Kansas from listeria – the first recall in the company’s 108-year history. The initial recall was limited to specific products, but was expanded … Continue Reading

Bodybuilder Beware: Study Raises Concerns About Speed-Like Substance in Supplements

Whether you’re a bodybuilder trying to lose that last percentage of body fat or an average person looking to lose a few extra pounds, weight loss supplements can offer a quick fix. But a number of popular fat-burning weight loss supplements may contain the chemical known as Beta-methylphenylethylamine (BMPEA), a stimulant recently criticized for its … Continue Reading

Supreme Court Declines to Weigh in on Generic Preemption

The United States Supreme Court has decided not to review Pliva v. Huck, an Iowa Supreme Court decision that held federal law does not preempt failure to update claims against generic drug manufacturers. Pliva challenged the ruling on the ground such claims were covered under the federal preemption memorialized in the 2011 U.S. Supreme Court … Continue Reading

Federal Fracking Rule Announced

The United States Department of the Interior (DOI) Bureau of Land Management issued a long-awaited final rule for hydraulic fracturing on federal lands. The rule was announced on Friday, March 20, 2015. According to the DOI’s press release these “commonsense standards will improve safety and help protect groundwater by updating requirements for well-bore integrity, wastewater … Continue Reading

Regulators and Researchers Focus on Secondhand Exposure to E-Cigarette Emissions

As regulatory clouds continue to gather over the electronic cigarette industry, public health researchers have set their sights on the potential risks these products pose to non-users. A study published this month in conjunction with the FDA’s second public workshop on e-cigarettes claimed that bystanders may be exposed to aerosol particles smaller than 1,000 nanometers, … Continue Reading

Lawsuits Fuel Debate About Powdered Caffeine

Two recent deaths allegedly resulting from the use of powdered caffeine has led to litigation and a public alert from the FDA, warning consumers of the dangers of the substance. One teaspoon of powdered caffeine is roughly equivalent to 25 cups of coffee. The product is not available in stores, but can be purchased in … Continue Reading

Retailers Slammed for Unpaid Taxes on Shipping and Handling Charges

Seller beware!  Hundreds of retailers that sell to Illinois purchasers have been sued for failing to properly collect sales and use tax.  In nearly every case, the plaintiff, an Illinois law firm, claims that the seller failed to collect the tax on shipping and handling charges billed to Illinois purchasers. These types of lawsuits often … Continue Reading

FDA Reopens Comment Period for Drug Labeling Rule

The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which … Continue Reading

FDA Issues New Draft Guidance That May Ease Approval for Drugs to Treat Alcoholism

The FDA has issued new draft guidance that may make it easier for pharmaceutical companies to develop and market drugs to treat alcoholism.  The proposed guidance provides that the FDA may approve drugs that help patients improve their drinking behavior, even if the drugs do not help patients achieve complete sobriety.  The draft guidance is being issued consistent … Continue Reading
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