Category: Consumer Product Safety

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

Second Circuit Finds Uninjured Plaintiffs Have Standing To Compel FDA Regulation Of Chemicals With Unproven Dangers

By Jesse Morris
Published on March 29, 2013

Last week, the Second Circuit released an opinion in a case brought by the National Resources Defense Counsel (NRDC) against the FDA seeking to compel the FDA to finalize regulation of chemicals contained in over-the-counter antiseptic antimicrobial soap.  In reviewing the lower court’s grant of summary judgment to the FDA on grounds that the NRDC lacked standing, the Second Circuit held that standing of an organization like the NRDC to bring this type of suit hinges on whether organization members have a significant risk of injury from the chemical for which regulation is being sought.  Such risk can be found where the member has proven definite exposure to the chemical and there are serious scientific arguments to suggest it may be harmful, even if its harm has yet to be proven.  In this case, since the NRDC was able to establish at least one of its members’ direct exposure to one of the chemicals – but not the other - the Second Circuit reversed the lower court’s decision and remanded the case with respect to the regulation of that chemical only.  On remand, the lower court will still have to determine whether the alleged possible medical risks posed by the chemical are sufficient to compel FDA action.

At issue in this case is the FDA’s regulation of the chemicals triclosan and triclocarban, antimicrobial chemicals that are found in soaps sometimes used in medical settings and elsewhere and which are classified as drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA).  Under the FFDCA, the FDA is therefore required to issue a finding as to whether these chemicals are safe and effective for their intended use before they can enter interstate commerce.  The FDA’s review on this matter is currently pending under the FDA’s Over-The-Counter Drug Review process, a process which dictates that the FDA will consider all antimicrobial agents together at one time.  Meanwhile, the FDA has determined that triclosan and triclocarban may remain on the market until that review is finalized since the FDA has not as of now determined any potential health hazard. 

The NRDC, an environmental action group,  filed this lawsuit under the federal Administrative Procedure Act (APA) which allows for private parties that are adversely affected by a federal agency’s inaction to compel that agency to take action.  The NRDC”s position is that the FDA has failed to take action to properly regulate triclosan and triclocarban, and the NRDC therefore seeks to compel the FDA to finalize its Over-The-Counter Drug Review for antimicrobial products.  The FDA argued in turn that the NRDC could not bring suit because under Article III of the Constitution there is no case or controversy between any of its members and the FDA with respect to the regulation of triclosan and triclocarban.   The lower court agreed, holding that because NRDC members could voluntarily avoid triclosan and triclocarban exposure, the NRDC did not have standing to bring this suit.

Concerns about triclosan and triclocarban stem from the fact that they are allegedly endocrine-disruptors and therefore may, among other things, adversely affect the reproductive system, contribute to the onset of hormone-dependant cancers, or potentially cause infertility in people who are exposed.  The NRDC argued that it has standing to bring suit regarding triclosan because its members have been directly exposed (citing the declaration of an NRDC member who washes her hands with this soap several times a day in her work at a veterinary clinic).  The NRDC simultaneously argued that its standing with respect to regulation of triclocarban stems from the fact that its existence on the market has the potential to increase the presence of antibiotic-resistant bacteria in the general population, despite the fact that no NRDC members have alleged direct exposure to this chemical. 

The Second Circuit, in reversing the lower court with respect to triclosan, held that NRDC members sufficiently established – as required under Article III – evidence that they were both injured-in-fact by triclosan and that their injury is traceable to the FDA’s conduct.  The Second Circuit opinion acknowledges both that there is scientific uncertainty about triclosan’s harmfulness and that NRDC members could potentially use triclosan-free soap, but did not find these facts to be barriers to meeting the elements of Article III standing: injury-in-fact for purposes of such standing is found from plaintiffs’ exposure to the triclosan coupled with expert testimony that shows triclosan may cause serious medical risk; causation for purposes of such standing is found in triclosan’s availability on the market alone.  Injury-in-fact was not found with respect to triclocarban, at least for NRDC plaintiffs, however, because rather than alleging an injury resulting from direct exposure, plaintiffs’ alleged injuries require an intervening occurence between triclocarban’s presence on the market and its potential affect on plaintiffs (the spread of antibiotic-resistant bacteria).

This is not the first case to find injury-in-fact, for purposes of standing to bring an APA action, to result from exposure to a harmful substance even without any medically adverse consequences to the plaintiff; in fact the Second Circuit cites an opinion it issued in 2003 in the case of  Baur v. Veneman, 352 F.3d 625, finding injury-in-fact where a plaintiff was potentially exposed to a known toxin.  The NRDC case is significant because of its holding that definite exposure to a potentially harmful substance is an injury equal to potential exposure to a proven dangerous substance; while the Second Circuit stated as much in its 2003 Baur holding, this recent NRDC case presents that actual fact pattern and affirms the court’s willingness to apply this rationale.  This case  sets a concrete example of the potential for APA suits to proceed that seek to compel increased regulation even of products for which current scientific studies of their hazards are inconclusive.  For regulatory agencies as well as the manufacturers of regulated products, this case then sounds a warning alarm.  At the same time, this case draws a distinction even among scientifically unproven harms: direct exposure to a product which is a potential endocrine-disruptor may give rise to APA standing, while indirect exposure to a product that allegedly leads to the potential proliferation of antibiotic-resistant bacteria will not.  So while this case may foretell of APA actions involving products that are not yet proven harmful, the alleged route of the harm is critical in determining whether there is risk of potential suit and if so, by whom.

Posted in Consumer Product Safety, Food and Beverage, Procedural Matters

The Cliff Take 2: Sequester Edition

By Christopher D. Barraza
Published on February 26, 2013

Last month, we discussed Congress’ last-second deal to avoid the “Fiscal Cliff.”  We noted that the deal did not tackle sequestration, but rather merely delayed the day of reckoning by two months.  That day is now here, as across-the-board budget cuts are set to kick in on Friday.  As of the time of this writing, the prospects for reaching a deal before the Friday deadline are dim.  Indeed, federal agencies have already begun sending out furlough notices.   Thus, once again, we find ourselves wondering what impact the sequester might have in the product safety regulatory space.

On January 22, CPSC Commissioner Robert Adler issued a statement on the agency’s Fiscal Year 2013 Operating Plan.  In the statement, the Commissioner made clear that even without the sequester, the agency’s budget appropriations were not sufficient for it to keep pace with the obligations imposed by the 2008 Consumer Product Safety Improvement Act.  The Commissioner identified a number of what he termed “Unfunded Worthy Projects” that have been slowed or postponed because of budgetary constraints, including: safety concerns with all-terrain vehicles (roll-over hazards), cooktops and electric portable heaters (fire hazards),  generators and furnaces (carbon monoxide hazards).  The Commissioner further suggested that any additional cuts would “gouge” the CPSC and its ability to fund safety projects and conduct regulatory oversight. Thus, were the sequester to occur, it appears that the CPSC would be greatly weakened in its ability to meet its statutory mandates.  And while the sequester could translate into decreased regulatory oversight by the CPSC, it could also mean that the CPSC responds more slowly to manufacturer and distributor concerns about reports of allegedly unsafe products posted on CPSC’s website.  Thus, a weakened CPSC would not necessarily be better for anyone, whether consumers or business.

Only time can tell whether the sequester will kick in, and even then the effects of the sequester will not be fully known until they play themselves out in the weeks and months ahead.  We will continue to monitor this situation and keep you posted.

Posted in Consumer Product Safety, Legislation, News

Energy Drinks Raise the Bar for FDA

By Jesse Morris
Published on December 3, 2012

Last week, in light of recent reports of injuries allegedly resulting from the consumption of energy drinks, the FDA released a letter indicating that it plans to change its approach to regulating these products.   Citing the fact that energy drinks are a “relatively new class of products,” the FDA plans to consult experts on their safety, including a review of how the various ingredients contained in energy drinks interact with one another.  This is somewhat new territory for FDA oversight, which generally focuses on reviewing ingredients individually for toxicity.   

The findings of the FDA’s investigation may lead to changes in labelling requirements, including disclosures about the levels of caffeine, warnings about health effects, and/or limitations as to how these products may be safely used.   Warnings may also address the products’ use by certain possible high risk populations, such as adolescents, pregnant women, and people with underlying health conditions.  As reported in the New York Times, this action by the FDA is unusual in its reliance on outside expert consultants, and may be modeled on similar regulatory action that is taking place in Canada with regard to high caffeine products.

What is interesting about these new developments is that they signify the FDA’s willingness to change its approach when evidence emerges that new products on the market may require different or more stringent levels of review.  And, even ingredients such as caffeine which have been accepted as safe in many products may trigger this increased scrutiny when used in volumes that some consider indicate a greater cause for concern.  We will continue to follow these developments and how decisions by the FDA may impact product liability issues for manufacturers and suppliers of these products.

Posted in Consumer Product Safety, Food and Beverage, Product Labeling Liability

Italian High Court Upholds Decision Linking Cell Phone Use To Brain Tumor

By Jed Winer
Published on October 22, 2012

In what various legal observers have called a “landmark” decision, the Supreme Court of Italy recently upheld a lower court decision linking a business executive’s brain tumor to his significant cell phone use.  While the available science and research has largely rejected the likelihood of such a causal connection, this decision could open the proverbial “flood gates” for cell phone and brain tumor-related litigation.  Manufacturers and suppliers of mobile phones will want to pay close attention to this decision as its impacts could be far reaching.  Indeed, as reported in The Telegraph, an oncologist and professor of environmental mutagenesis who testified for the plaintiff, Angelo Gino Levis, proclaimed that “[t]he court decision is extremely important. It finally officially recognises the link…It’ll open not a road but a motorway to legal actions by victims. We’re considering a class action.” Continue reading »

Posted in Consumer Product Safety, Expert Issues, News