Category: Legislation

Ninth Circuit Upholds USDA’s Refusal To Regulate Genetically Modified Alfalfa

By Jesse Morris
Published on May 20, 2013

Last week, the Ninth Circuit ruled in favor of the producers of alfalfa that has been genetically modified to withstand herbicides.  Traditionally herbicides that kill weeds could not be used in alfalfa farming because they killed the alfalfa crops as well; the engineered alfalfa seeds (known as “Roundup Ready Alfalfa” or RRA in the farming industry) are sold by the defendants as a crop system together with Roundup herbicide and are marketed to farmers looking for more efficient ways of growing alfalfa.  The plaintiffs are environmental and organic food advocacy groups, who argued that RRA would cross-pollinate with traditional alfalfa plants and potentially lead to the contamination of all alfalfa crops in the U.S., ultimately destabilizing the organic food industry and the ability of U.S. farmers to sell their products to countries with bans on genetically modified foods, not only with respect to organic alfalfa but also organic meats produced from animals who graze on it.

The plaintiffs previously sought an injunction to prohibit the production of RRA pending investigation by the USDA’s Animal Plant and Health Inspection Service (“APHIS”).  APHIS, however, has refused to regulate RRA since it is not a  plant pest, and plaintiffs appealed on the grounds that APHIS did not follow proper administrative procedure in examining all potential adverse effects of RRA or consdering the option of partial deregulation.  The Ninth Circuit affirmed summary judgment on behalf of defendants (who included APHIS as well as the producers of RRA and other industry members with interests in the outcome who had intervened in the case) on the grounds that neither APHIS, nor the FDA or EPA are actually required to address the types of environmental and economic harms at interest in this case.  Specifically, the Ninth Circuit explained that the FDA is authorized only to remove “adulterated” food from the the national food supply, a category that could potentially include genetically modified foods if they are found unsafe for consumption, but right now the FDA does not have any guidelines for reviewing these types of foods; the EPA is authorized to regulate genetically modified plants only indirectly, through its regulation of herbicides which are evaluated only for “unreasonable environmental risks;” and APHIS regulates only plant pests, which are defined as plants that cause injury, damage, or disease to other plants, and noxious weeds which are defined as aggressive and invasive weeds that have significant negative impacts and are difficult to control.  APHIS investigated RRA and f0und that it could not injure or damage other plants in a way that would qualify it as a plant pest and therefore deregulated alfalfa; the Ninth Circuit opinion holds that this was proper and also that APHIS need not have consulted further with other organizations about RRA’s potential threats.

This is a very interesting ruling in that it does not say that the federal regulatory agencies actually evaluated RRA for the types of adverse effects cited by the plaintiffs, namely those stemming from cross-contamination, but rather that there is really no such federal oversight of these issues at all at this time.  As domestic and international concerns about genetically modified foods rise alongside with the demand for and growth of the U.S. organic food industry, this may become an area for new legislation, with the field ripe for lobbying on both sides.   And the issues at stake, which include individual consumers, public health, the economy, the environment, and international trade, are wide enough to reach all interest groups.  We will continue to monitor.

Posted in Food and Beverage, Legislation

FDA Flexing its Muscle with Compounding Pharmacies

By Christopher D. Barraza
Published on May 7, 2013

Last week, my colleague wrote about proposed legislation in the Senate that would increase FDA oversight of compounding pharmacies.  As the bill works its way through the legislative process, we thought it might be helpful to talk more about how FDA has been conducting oversight of compounding pharmacies within the existing regulatory framework.  The short answer is that in the wake of New England Compounding Company meningitis outbreak last fall, FDA has brought a record number of enforcement actions.

Consider this statistic: FDA has pursued more enforcement actions in the first four months of 2013 than in the previous five years combined.  Thus far this year, FDA has issued almost four dozen inspectional observations, which are often referred to as “Form 483s”  or “483s,” compared with approximately two dozen 483s and warning letters from 2008 through 2012.   FDA is authorized to perform inspections of compounding pharmacies under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374) and uses 483s to document and communicate concerns discovered during these inspections.  Although Form 483s are not a final agency determination, they are often a precursor to regulatory action, which can include a formal warning letter, withholding of product approval, or plant shut down.  And 483s yield results: FDA’s stepped up oversight has lead to six voluntary recalls by compounders so far in 2013. 

There are questions about how long FDA can sustain its recent enforcement action pace, since focusing on compound pharmacies requires FDA to shift resources from other areas.  What is clear, though, is that regardless of pace, FDA is now very much engaged on the issue of regulatory oversight of compounding pharmacies and will continue to pay particular attention to this issue.  Whether that will result in more litigation remains to be seen but FDA tighter regulation often brings more private lawsuits in its wake.  We will continue to monitor developments in this area.

Posted in Legislation, News, Pharmaceutical Law

EPA Report on Greenhouse Gas Emissions May Become Part Of Ongoing Fracking “Debate”

By Jed Winer
Published on May 2, 2013

Here at Weil’s Product Liability Monitor, we keep a close eye on developments relating to hydraulic fracturing — more commonly known as “fracking.”  In a nutshell, “fracking” is a well stimulation technique that employs high-pressure fluids to break up gas trapped in shale rock formations.  My colleague, Sylvia Simson, is a frequent contributor on the subject.  For a recent analysis Ms. Simson wrote along with Arvin Maskin on the subject of fracking in New York State, please click here.

Now comes news from the EPA that one of the controversies relating to fracking — air pollution from the release of the “greenhouse gas” methane during natural gas production – may be of less concern than originally estimated.

Continue reading »

Posted in Legislation, Risk Management Policy, Uncategorized

Senate Draft Bill Proposes FDA Authority Over Certain Types of Compounding Pharmacies

By Meghan A. McCaffrey
Published on April 29, 2013

Proposed legislation this past Friday from the Senate Health Committee would provide the FDA with greater authority over certain compounding pharmacies, helping clarify the legal landscape around the FDA’s authority over the industry (as we posited may happen here and here).  The proposal comes in response to vocal criticism from members of Congress that the agency failed to act aggressively enough in its oversight of compounding in the wake of the meningitis outbreak last fall that killed more than 50 people and sickened more than 700.  The outbreak, linked to tainted steroids distributed by the New England Compounding Center, led to calls from FDA Commissioner Hamburg for legislation to clarify the agency’s role.  See our coverage of this issue as it developed here, here and here.    Continue reading »

Posted in Legislation

Energy Drink Update: New Marketing Strategies, Continued Push for Regulation

By Natalie Blazer
Published on April 15, 2013

 As readers of the Monitor know, we have seen an increasing amount of scrutiny in recent months surrounding so-called “energy drinks,” particularly in the wake of reports linking consumption of such beverages to multiple deaths. Just last month, a study was released finding that energy drinks may boost blood pressure and lead to an erratic heartbreak, and doctors have written to Food and Drug Administration (FDA) Commissioner Margaret Hamburg saying energy drinks should have no more caffeine than sodas and companies should be required to list caffeine content on the labels. Meanwhile, energy drink manufacturers have consistently and vigorously defended the safety of their products. As more studies are published and the medical community voices its concern over these products, litigation has proliferated and lawmakers are taking notice.

The congressional charge has been led by senators Dick Durbin (D-Ill.), Richard Blumenthal (D-Conn.), and Rep. Ed Markey (D-Mass.), who initially urged the Food and Drug Administration last year to convene an expert panel to discuss the effects of consumers’ caffeine consumption. More recently they have sent letters to energy drink companies (including Monster Beverage Corp., Red Bull North America, and Rockstar Inc.), asking about their marketing strategies and the safety of their products, ultimately telling them to stop marketing their beverages to children.

In February the three lawmakers wrote the leaders of the National Collegiate Athletic Association (NCAA) and the National Federation of State High School Associations (NFHS), asking for information on how the organizations are educating student-athletes about the possible health risks of energy drinks. The letters also inquired as to any marketing restrictions the organizations placed on energy drink manufacturers during athletic events.

The NCAA responded that it has devised several policies to limit access to “energy products” because they pose a health and safety risk to student-athletes. The NCAA’s letter further stated that NCAA Advertising and Sponsorship Standards prohibit energy product manufacturers from sponsoring NCAA championships and certified postseason bowl games. The NFHS, for its part, informed the lawmakers that it has been warning student-athletes of the risk of energy drinks for more than a decade.

The response of these organizations is notable, given the uncertainty surrounding the risks of energy drinks and the fact that they have traditionally maintained an unregulated status (Daniel Fabricant, director of the FDA’s dietary supplement division, acknowledged in an interview in October that energy drinks are not in fact defined by any regulation). 

Like many other companies, Monster Beverage – the nation’s largest seller of energy drinks – initially sold its products as dietary supplements, apparently as part of a strategy to convince consumers that they were different from beverages. However, as of March 2013, after a decade of being sold as a dietary supplement, Monster has begun marketing its energy drink as a beverage. While this means the company will no longer be required to comply with federal regulations that apply to dietary supplements, they will now be required to comply with the various rules and regulations that apply to beverages. The company will likely face new reporting mandates as beverage producers, and they will be required to maintain scientific data supporting the safety of any ingredients they use that are not already cleared by the government. 

In addition, Monster Beverage’s new cans will disclose caffeine content for the first time. A 16-ounce can of Monster’s most popular energy drinks will contain 140-160 milligrams of caffeine, compared to about 330 milligrams in a 16-ounce Starbucks coffee. This should, at the very least, allow the company to dispute claims that the beverages’ caffeine content is markedly more than in a cup of coffee (indeed, Monster’s most popular drinks appear to contain less than half the caffeine of coffee).

Monster’s marketing move followed a similar regulatory “makeover” by another brand, Rockstar Energy, according to the New York Times. More companies may follow suit, which could lead to more labels on cans and potentially more informed choices by consumers.

At first, most energy drinks were not bound by FDA guidelines because they were sold as dietary supplements rather than as beverages. This meant that while soda can legally have as many as 71 milligrams of caffeine per 12 ounces, caffeine in energy drinks could range from 160-500 milligrams in a serving. This apparent regulatory loophole caused a stir when Monster Beverage, like its competitors, faced the disclosure in October that the FDA had received reports that mentioned energy drinks in connection with deaths and injuries. Of course, the mention of a product in an incident report filed with the FDA does not mean the product played any role in a death or injury, but it can cause serious problems for companies in terms of fending off lawsuits. The new can labels and reporting mandates may help energy drink companies avoid these types of suits in the future.

Despite the new labels and the companies’ obligation to comply with additional reporting requirements, Congress continues to seek increased regulation in this area, whether the drinks are marketed as “supplements” or “beverages.” For his part, Senator Durbin announced in March that he will reintroduce the Dietary Supplement Labeling Act, which he and Blumenthal originally introduced in 2011.

We are sure to see continuous developments in energy drink legislation and litigation in the coming months, and we will be sure to keep you posted. You can read our previous coverage on this issue here and here.

Posted in Consumer Product Safety, Food and Beverage, Legislation