David Pacheco
David Pacheco is an associate practicing in the Technology and Intellectual Property practice group. A large part of his practice consists of helping nutrition companies procure, register, and maintain trademarks, copyrights, and trade secrets throughout the world. He also assists those clients maximize the potential of intellectual property through licensing, development, and marketing. David is also a source of information for clients navigating the federal and local laws and regulations regarding multilevel marketing and related business models.
The Dietary Supplement Industry is Thriving, Especially in Utah, the "Silicone Valley" of the Industry.
.jpg)
.jpg)
Despite the economy, the dietary supplement industry is thriving, writes Erik Krusch in a Westlaw Business article published today. Mr. Krusch reports on continued M&A and IPO activity in the industry in a time where the number of such deals in other industries has stayed low. As stated in the article, this data shows the resiliency of the industry and is proof of a strong market for dietary supplements, even in tough financial times.
The author also singles out Utah as a major factor in the industry's strength, call
ing Utah the "Silicone Valley" of the industry and citing Utah-based companies as the source of a fifth of all dietary supplement production in the U.S. Mr. Krusch identifies the state's friendly direct sales laws and support from Sen. Orrin Hatch as factors contributing to Utah's position in the industry. The Nutrition Law Blog authors, being based in Salt Lake City, can attest to the strength of the industry and the favorable business conditions in Utah.
This is, of course, great news for the industry, especially for the Utah companies.
It's Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now
President Obama signed into law today the Food Safety Modernization Act (FSMA).
Companies with facilities subject to FDA jurisdiction should take immediate steps to review and, where necessary, modify SOPs, policies and procedures.
For example, given the FDA's expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may have to turn over and what they may not. Food companies should take steps to protect confidential and proprietary information.
Companies also should anticipate now how they need to change their policies and approaches to mandatory recalls and whistleblower protections.
These parts of the legislation take effect today:
- Stronger records access authority by FDA (FSMA § 101)
- When FDA determines a "reasonable probability" of "serious adverse health consequences"
- FDA can access records of other food affected in a similar manner
- But FDA must show proper credentials and provide written notice
- Mandatory recall authority (FSMA § 206)
- FDA can order a recall if it finds a "reasonable probability" that
- food is adulterated or misbranded; and
- there may be serious adverse health consequences
- FDA has to provide an opportunity for a voluntary recall
- FDA will provide an informal hearing within two days of the order’s issuance
- FDA can order a recall if it finds a "reasonable probability" that
- Increased frequency of inspections (FSMA § 201)
- FDA will immediately increase the frequency of inspections
- FDA will apply a risk-based approach to determine priorities
- Whistleblower protection (FSMA § 402)
- Protects employees who:
- Provide information re violation of FDC Act ,
- Testify, assist or participate in a proceeding re a violation, and/or
- Object to "activity, policy, practice or assigned task" they "reasonably believe to be a violation"
- Protects employees who:
- Refused admission of imports if foreign facility refuses inspection (FSMA § 306)
- Foreign establishments must allow entry to U.S. inspectors within 24 hours of requesting entry
- Or imported food will be refused admission.
Future blog entries will discuss compliance with other provisions of the FSMA scheduled to be phased-in. If you are interested in a more detailed in-house discussion of the FSMA and its effect on your company, please let us know.
2010 Wrap-Up
With 2011 nearly upon us, we have taken a look back at the news from 2010 and the posts from the inaugural year of the Essential Nutrition Law Blog and have created a list of what we feel were the top five news stories affecting the nutrition industry in 2010. Below are our choices, in no particular order. Feel free to weigh in in the comments.
1. Senator McCain’s “Dietary Supplement Safety Act”. We began the year with the threat of more stringent regulations for dietary supplement manufacturers under a bill backed by Senator McCain. The Senator backed away from the bill in March, much to the delight of Senator Orrin Hatch. This was, of course, great news for the industry.
2. Litigation for False Claims and Deceptive Advertising. We saw a number of high-profile cases in 2010 where companies were sued for false claims or deceptive advertising in connection with dietary supplements and functional foods. For example, Dannon will pay 66 million to settle a class action suit and an action brought by the attorneys general of 35 states, the FTC put an end to some claims regarding acai berries, consumers sued Coca-Cola for claims made related to Vitamin Water, and a U.S. Attorney in Wisconsin brought suit against Beehive Botanicals, resulting in federal officials seizing a number of products from the company.
3. The FDA begins enforcing GMP’s. In May, the FDA sent out its first warning letter related to a GMP inspection, indicating that the FDA is finally enforcing the GMP regulations first announced in 2007. For tips on preparing for a GMP inspection, read Jonathan Stagg's post here.
4. The November Elections. The November elections shook things up in Washington, especially in the House of Representatives, where we saw the largest shift in party control in over six decades. There has been much speculation over how this will affect legislation for the remainder of President Obama’s first term in office. In addition, most analysts predict that the results of the 2010 Census will likely favor Republicans. This change could obviously alter how the nutrition industry is perceived by federal lawmakers, and could affect legislative efforts like the Dietary Supplement Safety Act.
5. Passage of the Food Safety Bill. The year ended with the Senate passing the Food Safety Modernization Act which updates the food regulations that have been around for over 70 years. Assuming President Obama signs the Bill into law, it will bolster the FDA's ability to monitor food imports and will shift the regulatory focus to the prevention of contamination. The dietary supplement industry generally welcomes the update. For more in-depth coverage of the Food Safety Bill, visit the Food Liability Law Blog.
Dannon Forced to Open Wallet and Change Advertising (Again)
.jpg)
The multinational food company Dannon agreed to a 45 million dollar class action settlement earlier this year based on consumer complaints about advertising claims regarding the health benefits of its probiotic line of dairy products. Now the company has entered into a $21 million dollar settlement with the attorneys general from 39 states. The L.A. Times reports that this is the largest-ever multistate attorney general consumer protection settlement with a food producer. The attorneys general alleged that Dannon made deceptive and unlawful claims in advertising which were not substantiated by competent and reliable scientific evidence at the time the claims were made. According to the allegations, the majority of scientific studies showed improvement in intestinal transit time when an individual consumed three servings of the probiotic products per day for two weeks, and did not support Dannon's advertised claims that one serving per day for two weeks improved digestive health. In addition, the attorneys general alleged that Dannon could not substantiate claims regarding improved immunity against the flu and common cold.
Dannon also agreed with the FTC to drop claims that the probiotic foods help prevent irregularity and offer protection against the flu and common cold. The FTC found no substantiation of these claims. This isn’t the first time Dannon has had to alter its advertising; the March settlement required Dannon to remove specific language about the health benefits of the products from labels and advertising.
Between this and the March settlement, Dannon has now agreed to pay $66 million as restitution for the misleading health claims, which comes out to about 1.3% of Dannon reported $5 billion in worldwide net sales of the probiotic line in 2009. This latest settlement should remind companies to keep state governments on the list of watchful eyes monitoring health claims related to food and supplement products.
5-Hour Energy v. 8-Hour Energy: Monopolization Claim Flops
By Guest Blogger Joseph Eckhardt
In an unfair competition suit under 15 U.S.C. § 1125, the king of the two-ounce energy shot, 5-Hour Energy, is suing the makers of 8-Hour Energy in the Eastern District of Michigan, claiming that 8-Hour Energy falsely associates itself with 5-Hour Energy. 8-Hour Energy has tried to strike back with a monopolization claim, arguing that 5-Hour Energy has engaged in a number of anticompetitive tactics to drive away competitors like 8-Hour Energy, and 6-Hour Energy, which 5-Hour Energy sued in 2008.
.jpg)
Anyone who has recently set foot in a convenience store or watched late night cable television knows how valuable the energy drink business has become. To get an idea of how this market has grown, take a look at the wall of energy drinks displayed at thescreamingenergy.com product review web site. Perhaps the most valuable spot in that market is in the two-ounce “energy shot” space, on the counter next to the cash register, where customers are willing to pay $3.50 for two ounces of an elixir that will “help you feel sharp and alert.” (By comparison, a consumer will seldom pay more than 99 cents for a 12 ounce can of caffeinated cola.) And the consensus is that 5-Hour Energydominates this category.
The 8-Hour Energy defense team may have a good argument that 5-Hour Energy is the king of the convenience store counter, but the Eastern District of Michigan issued an Order last week slapping down 8-Hour Energy’s monopolization claim. 8-Hour Energy argued that 5-Hour Energy engages in anticompetitive tactics to control the market, but failed to convince the court that those tactics actually harm 8-Hour Energy. For example, the court noted that anything 5-Hour Energy did to exclude 6-Hour Energy from the market couldn’t have harmed 8-Hour Energy. Ultimately, 8-Hour Energy should be able to argue that any anticompetitive conduct is relevant to prove that 5-Hour Energy has harmed competition – this may be an issue that 8-Hour Energy can exploit on appeal.
The court’s order provides a good example of the risks associated with raising antitrust counterclaims. Here, the Eastern District of Michigan dismissed 8-Hour Energy’s monopolization counterclaim for failure to convincingly plead the claim. If 8-Hour Energy somehow revives the claim, the next hurdle will be definition of the relevant market. Is there an exclusive market of 2-ounce energy drinks? If Red Bull, Coca Cola, or coffee are reasonable substitute “energy drinks,” 8-Hour Energy’s monopolization case doesn’t have a chance.
Federal Court Ends Alleged "Super Berry" Scheme (For Now)
.jpg)
A U.S. District Court in Illinois, at the request of the Federal Trade Commission, has issued a 
.jpg)
preliminary injunction freezing the assets of two individuals and five related companies selling dietary supplements derived from the acai berry. According to the FTC, the defendants engaged in a number of deceptive practices in violation of the FTC Act including advertising false celebrity endorsements by Oprah Winfrey and Rachel Ray, making misleading claims regarding the health benefits of the supplements, and providing misleading information regarding the prevalence and severity of illnesses and health conditions which the supplements were intended to cure and prevent. The FTC’s complaint not only cites misleading health claims regarding the fruit, but also alleges that the companies repeatedly deceived consumers by fraudulently charging their credit cards during and after “risk free trials” of the supplements. In addition to this preliminary injunction, the FTC is seeking a permanent injunction, damages for injured consumers, and costs and attorney’s fees. The defendants’ answer is due August 31, 2010.
This suit is another warning to the supplement industry that the FTC, along with the FDA and consumers, are paying special attention to the claims and practices of dietary supplement companies.
The Show Goes On: USDC Allows Vitaminwater Lawsuit to Proceed
By Guest Blogger Tyler Anderson
In an opinion issued on July 21, 2010, Judge John Gleason of the United States District Court for the Eastern District of New York largely denied the defendant’s motion for dismissal and held that 10 of the 13 claims in a class action suit brought against Coca-Cola for alleged unlawful health claims on its Vitaminwater drinks could proceed. The claims that still must be examined in court include allegations of misleading advertising, fraudulent business acts, and unfair methods of competition.
The plaintiffs in the class action, which include the health advocacy group Center for Science in the Public Interest (“CSPI”) as co-counsel, contended that Vitaminwater’s labeling and marketing is misleading because it (1) communicates a number of purported health benefits (including healthy joints, optimal immune function, and reduced risk of chronic disease), drawing consumer attention away from the significant amount of sugar (33 grams per bottle) in the product; (2) portrays Vitaminwater as healthy when it is essentially a snack food that provides nutritional benefits because it has been specifically fortified to do so; and (3) suggests that Vitaminwater contains nothing but vitamins and water.
While the court concluded, citing applicable Food and Drug Administration (“FDA”) rules and commentary, that sugar was not a “disqualifying nutrient” under applicable FDA regulations, the plaintiffs’ latter two claims were found to accurately describe violations of FDA regulations, and accordingly may serve as a non-preempted basis of state law liability.
The FDA regulations restricting health claims or implied claims of healthiness related to foods that meet certain minimum nutrient levels, colloquially termed “the jelly bean rule,” were developed in an effort to prevent food producers from encouraging the consumption by consumers of junk food by fortifying the food in question with nutrients. The “jelly bean rule” is applicable only to (1) health claims, and (2) nutrient content claims that use the word “healthy” to suggest that a food may help consumers maintain healthy dietary practices because of its nutrient content. Finding that Vitaminwater’s labeling contains claims in each of these two categories, the court ruled the plaintiffs could proceed with this claim.
The plaintiffs alleged Vitaminwater’s labeling is misleading because it uses a product name that includes two of the product’s ingredients (vitamins and water), but fails to mention another notable ingredient (sugar). FDA regulations on this subject recognize that such product names have the potential to mislead consumers. Thus, the court held that the plaintiffs were allowed to pursue this claim. In the aftermath of this ruling, Coca-Cola released a statement expressing their confidence that the plaintiffs’ claims are without merit and will ultimately be rejected. Given that the implications this case could carry into the growing functional food and beverage segments of the market, we will continue to track it closely.
Stoel Rives and ACC Mountain West To Host Nutrition Law Symposium
For more information, contact Melanie Williamson, Stoel Rives Business Development Coordinator, at (801) 715-6662 or mwwilliamson@stoel.com.
Steve Mister of CRN: We Need "Better Enforcement of the Law, Not a Rewrite of It"
Steve Mister, President and CEO of the Council for Responsible Nutrition, authored an op-ed article for USA Today where he argues that the current laws regulating dietary supplements are effective, but need better enforcement. According to Mr. Mister, the dietary supplement industry supports full implementation of the laws as a way to weed out the few unethical practices and companies from an otherwise legitimate industry. The article is part of Mr. Mister's efforts to promote the passage of the Dietary Supplement Full Implementation and Enforcement Act and CRN's efforts to promote compliance and ethical practices in the industry.
FTC Announces Intent to Issue Compulsory Process Orders Regarding Marketing of Food and Beverages
By Guest Blogger Tyler Anderson
This post also appears on The Food Liability Law Blog
In a May 25, 2010, Federal Register Notice, the Federal Trade Commission (the “FTC”) announced its intention to issue compulsory process orders to 48 food and beverage manufacturers, distributors, marketers, and quick service restaurant companies. The proposed orders seek information concerning the companies’ marketing expenditures targeted toward children and adolescents, and nutritional information about the companies’ food and beverage products marketed to children and adolescents.
The proposed orders, issued under Section 6(b) of the Federal Trade Commission Act, 15 U.S.C. § 46(b), will seek information in six categories, including:
• The categories of foods marketed to children (ages 2-11 years) and adolescents (ages 12-17 years);
• The types of measured and unmeasured media techniques used to market food products
to children and adolescents;
• The amount spent to communicate marketing messages about food products to children and adolescents;
• The nature of the marketing activities used to market food products to children and adolescents;
• Marketing to children and adolescents of a specific gender, race, ethnicity, or income level; and
• Marketing policies, initiatives, or research in effect or undertaken relating to the marketing of food and beverage products to children and adolescents.
By procuring this information, the FTC will be able to evaluate the impact of self-regulatory efforts on the nutritional profiles of foods marketed to children and adolescents. In addition, the FTC seeks to determine and analyze how companies allocate their promotional activities and expenditures among various media and for different food products. Interested parties may submit comments on or before June 24, 2010.
This FTC action is a follow-up to its July 2008 report entitled, Marketing Food to Children and Adolescents: A Review of Industry Expenditures, Activities, and Self-Regulation. That report represented the findings of a 2006 FTC study of promotional activities related to food and food products targeted toward children and adolescents. It found that, while room for improvement existed, the food and beverage industries had made significant progress on this front since the FTC and the Department of Health and Human Services co-sponsored a Workshop on Marketing, Self-Regulation & Childhood Obesity in 2005. As everyone from the First Lady to the World Health Organization is focused on the impact of marketing on childhood obesity, the results of this FTC action will bear monitoring.
