A "Surprise" for Your Sweet Tooth: FDA Revisits Inedible Objects in Candy
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Many of you may be familiar with the famous confection known as the Kinder Surprise or Kinder Egg, a toy-filled chocolate that is touted as the single largest children’s candy category in the world. The treat is manufactured by the Italian company Ferrero and has risen to nearly cult status in certain countries. Kinder Eggs are sold worldwide; however, U.S. consumers have likely only tried the confection while traveling abroad or through some other surreptitious means. The candy has been banned in the United States for decades.
This Spring, though, U.S. consumers might see something similar to the Kinder Egg in their Easter baskets. Kevin Gass, one of the founders of Candy Treasure LLC located in New Jersey, has developed a safe alternative to the Kinder Egg that meets the approval of both the U.S. Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC).
The FDA has long viewed the practice of intermingling confectionaries with trinkets with apprehension because of the potential choking hazard it presents. In fact, Section 402(d)(1) of the Federal Food, Drug, and Cosmetic Act expressly states that a confectionery is deemed to be adulterated “if it…has partially or completely imbedded therein any nonnutritive object,” unless the nonnutritive object has a functional value and would not be injurious to health.
Continue Reading...Turn your Bar Bill Into a Federal Case
A guy walks into a bar . . .
No, seriously, a guy walks into a bar. He orders a couple of beers and a couple of drinks. His bill comes. He pays his bill. He leaves.
Sounds like something that happens everyday, thousands of times a day, right? Let's try it again.
A guy walks into a bar. He orders a couple of beers and a couple of drinks. He doesn't ask what the drinks will cost. The person who waits on him does not tell him. His bill comes. He pays his bill. He leaves. He sues.
If you're wondering what he's suing about, you're not alone.
Learn what happened after the jump.
Continue Reading...FDA Cracks Down on Company's Facebook "Likes"
Social media has become a critical component of a company’s product marketing and promotion. However, based on FDA’s increased enforcement action around social media activity, it is a risk to be carefully considered.
The Food and Drug Administration (FDA) recently published a December 11, 2012 warning letter on its website that cited a dietary supplement company for its improper social media activity, among other things. Specifically, the warning letter explained that the supplement company’s “liking” of a consumer testimonial posted to its product Facebook page was a violative claim in that it established the product as a drug intended to cure, mitigate, treat, or prevent a disease. The FDA noted in its warning letter that the liking of the following March 10, 2011 Facebook post by the company constituted an impermissible disease claim:
“[Product]has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation.”
The company has since removed this content from its Facebook page.
This is not the first time that FDA has scrutinized a company’s use of social media. In the past two years, over a dozen companies have been cited by FDA for making improper claims on the company or product Facebook page or Twitter account. However, this is the first time FDA has interpreted that a “like” implies endorsement of an unapproved claim.
There is some speculation that a crackdown on similar social media activities, such as “retweeting” a post on Twitter or “+1” on Google+, might be next on FDA’s agenda. In light of this regulatory risk, companies should ensure consider drafting formal social media policies and thoroughly vetting all social media marketing strategies to avoid enforcement action.
New York "Big Gulp" Ban Bites It For Now
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Among the ironies connected to New York's attempt to ban large cups of soda is the fact that the last time I was in the city, before the advent of 7-11 to its precincts, the one thing I really craved was a really large cup of Dr Pepper. When I visit New York, on business or for pleasure, I typically walk miles and miles, and on a hot day an icy cold cup of soda (I prefer the Diet) is what I need to refresh myself. I think I found one place that had it, but then again Dr Pepper is less common in the East.
A lot has been written about this ban both before and after a New York Supreme Court judge struck it down on Monday. Some of it has been fairly misleading and some of it has been relatively accurate. The case has nothing to do with equal protection under the U.S. Constitution, or indeed the U.S. Constitution at all. Rather, it was mainly decided based on an interpretation of a document that is, in its origins, older than the Constitution: the New York City Charter, a document that began in the reign of James II, the man for whom the city and state were named. Ultimately, the question was not so much the wisdom of the ban, but whether the Board of Health, a body appointed entirely by the Mayor without even City Council ratification, had the power to institute it, or whether that power was held by the City Council or the New York State Legislature, each of which had failed to pass similar legislation. Unless you are seriously concerned about the separation of powers doctrine under New York law (city or state), the vast majority of the case is of little interest and creates no precedent for what other jurisdictions may or may not do.
Much attention has been given to the judge's alternative ruling that the ban was "arbitrary and capricious" because it covered only some establishments and because it exempted certain drinks. The former of these is really a question of the authority of the Board of Health, which by a "memorandum of understanding" has ceded jurisdiction over grocery stores and convenience stores, as opposed to restaurants, to the state authorities. The court hints, however, that one problem with the ban is that that Board of Health did not seek, before imposing it, to coordinate with the state, which the MOU apparently required.
The latter can certainly be criticized. If you can get unlimited refills of a 16 ounce cup, have you accomplished anything? Some would argue that you have. Alcoholic beverages and milk-based beverages were exempt, which raises other issues. An article on the Bloomberg website, of all things, suggests that the result of the judge's action might be a broader ban. The director of the World Health Organization's Orwellian-sounding "Center on Public Health Law and Human Rights" argues that the ban was "legal and right." Mayor Bloomberg, not surprisingly, vows to succeed on appeal.
More interesting is the number of different ways in which New York restaurants had chosen to comply with the ban, and the cost of being required to be in a position to comply only to have the ban struck down just before it went into effect. 16 oz. cups were at a premium in the city before the ban was struck down; as the case goes through appeal, there will be more uncertainty about what those subject to the former ban may do, and if the mayor wins on appeal, how quickly they would have to comply with a reintroduced ban. While the organizations that challenged the law clearly had the right to do so, for many New York restaurant owners the real concern is certainty. They'd rather know what their duties are far in advance of having to implement them because they can't change their practices on a dime. This appeal doesn't do them any favors at all.
The Case That Makes You Go "Ewww"
You've heard about this case. It's the story of the cop whose burger was spat on in Vancouver, Washington.
The Washington Supreme Court's decision in Bylsma v. Burger King Corp., which covers a tiny but critical part of the policeman's lawsuit, has gotten a lot of publicity. Let me give you three quick points that most of the reporting misses:
- The guy who spat on the burger pled guilty to assault and was sentenced to 90 days in jail, was fired, and is not a defendant in the lawsuit.
- The lawsuit, as it currently stands, has nothing to do with respondeat superior or whether the restaurant was negligent in hiring the guy who spat.
- The case was decided under Washington law, and the real impact will be under Washington's Products Liability Act, which gives restaurants like the Burger King franchise here, and Burger King itself, few defenses to this action.
Much more after the jump.
Continue Reading...Register Today for FDA's Public Meetings on Two Major FSMA Proposed Rules
Earlier this year, the Food and Drug Administration (FDA) made some progress toward implementing the Food Safety Modernization Act (FSMA) by issuing two new proposed food safety rules. Specifically, the agency published proposed rules to establish standards for (1) growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Rule”) and for (2) current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the “Preventive Controls for Human Food Rule”).
These two proposed rules are just the first step for establishing the framework for the modern food safety system called for by FSMA. Eventually, the FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors. A helpful overview of the proposed Produce Safety Rule and the Preventive Controls for Human Food Rule can be found here.
The FDA is currently in the process of soliciting comments on the proposed rules from industry stakeholders. The public may offer comments to the proposed rules over the course of the next several weeks. To facilitate that process FDA is planning to host two additional public meetings in Chicago, IL and Portland, OR in March. These meetings are the second and third in a series of public meetings announced in the January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first public meeting will be held February 28-March 1, 2013, at the U.S. Department of Agriculture in Washington, DC.
Continue Reading...Initiative 522 Forwarded to the Washington State Legislature
After reviewing the voter petitions filed in support of Initiative 522 (I-522), the Washington Secretary of State’s Election Division announced last Friday that the measure received enough signatures and has been certified. The official certification was signed by Secretary of State Kim Wyman.
I-522, also known as “The People’s Right to Know Genetically Engineered Food Act,” concerns the labeling of genetically engineered foods. Similar to Proposition 37 that was recently rejected by California, I-522 would require most raw agricultural commodities, processed foods, seeds and seed stocks, if produced through genetic engineering, to be labeled as such when offered for retail sale.
Now that initiative has been certified, it will be forwarded to the Legislature. Legislators have three options on an initiative sent their way: (1) pass it into law as is; (2) take no action, resulting in it going to the November ballot for a public vote; or (3) send it and a legislative alternative to the ballot and let voters decide which, if either, they support. Lawmakers commonly take the second approach and pass the initiative along to the public for a vote.
Final updates for I-522 can be seen here.
Stoel Rives Opens Office in Washington, D.C.
We are pleased to announce that we have opened a satellite office in Washington, D.C. Our new address, effective immediately:
Stoel Rives LLP
1020 19th Street NW, Suite 375
Washington, DC 20036
Phone: (202) 398-1795 / Fax: (202) 621-6394
The new office is headed by firm partner Greg Jenner, a former Deputy Assistant Secretary of the U.S. Treasury for Tax Policy and Tax Counsel to the U.S. Senate Committee on Finance.
Click here to read the press release.
Food Processors from Around the World Visit the NWFPA Expo
Today begins the annual NWFPA Expo event that draws food processors from around the world. The three day event is taking place at the Portland Convention Center and will include educational sessions as well as an exhibition hall. Stoel Rives attorneys will be attending the event and hope to see you there.
Another GMO Labeling Iniative on the Horizon, This Time in Washington
Last week on January 3, 2013, sponsors of Initiative 522 (I-522), a measure that would require the labeling of certain genetically engineered foods, filed their petitions with the Washington Secretary of State’s Office for review.
The filing of I-522 comes in the wake of Proposition 37, a similar initiative that was ultimately rejected by California voters in November 2012. If enacted, I-522 would require that any food offered for retail sale in Washington that is, or may have been, entirely or partly produced with genetic engineering to be labeled as follows:
- In the case of a raw agricultural commodity, the package offered for retail sale must clearly and conspicuously display the words “genetically engineered” on the front of the package, or where such a commodity is not separately packaged or labeled, the label appearing on the retail store shelf or bin where such a commodity is displayed for sale must display the words “genetically engineered;”
- In the case of any processed food, the front of the package of such food must clearly and conspicuously bear the words “partially produced with genetic engineering” or “may be partially produced with genetic engineering;” and
- In the case of any seed or seed stock, the seed or seed stock container, sales receipt or any other reference to identification, ownership, or possession, must state clearly and conspicuously that the seed is “genetically engineered” or “produced with genetic engineering.”
FDA Releases Two New Proposed Food Safety Rules
On January 4, 2013, exactly two years after the Food Safety Modernization Act (FSMA) was signed into law by President Obama, the Food and Drug Administration (FDA) published two new proposed food safety rules that will be available for public comment for the next 120 days.
The first rule on “Preventive Controls for Human Food” sets safety requirements for facilities that process, package or store food to be sold in the United States, whether produced at a foreign or domestic-based facility, for human consumption. A separate rule will be issued for animal food in the near future. The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness similar to Hazard Analysis and Critical Control Points (HACCP) systems that are already required by FDA for juice and seafood processors. Each covered facility would be tasked with preparing and implementing a written food safety plan, which would include the following:
- Hazard analysis;
- Risk based preventive controls;
- Monitoring procedures;
- Corrective actions; verification; and
- Recordkeeping.
The FDA is also seeking public comment on a second proposed rule, which proposes enforceable safety standards for the production and harvesting of produce on farms.
Continue Reading...Battle Over Labeling Genetically Modified Food Continues
Our colleague Claire Mitchell recently published an article in Law360 that discusses a recent class action lawsuit filed against Pepperidge Farm, Inc. in Colorado on November 6, 2012. The complaint alleges that Pepperidge Farm misrepresented its Cheddar Goldfish crackers as “natural” when, in fact, they contain Genetically Modified Organisms (GMOs). The lawsuit is one of many class action suits that have been brought against food and beverage companies over the past few years claiming that the marketing of certain products as “natural” is false and misleading.
Claire explains possible ways for companies to avoid this type of litigation as well as the importance of being prepared for a lawsuit. She writes:
“Natural” labeling and advertising litigation has been both costly to food and beverage companies and damaging to their reputation. In order to avoid litigation, companies should take preventative measures such as reviewing their products’ ingredients for the presence of synthetic preservatives or other artificial or “unnatural” ingredients; examining product labeling, advertising, marketing and other promotional materials to ensure that all claims being made are accurate and compliant; and perhaps even considering whether the use of the term “natural” is worth the potential exposure to litigation.
It is also important for food and beverage companies to be prepared to defend against such lawsuits. Several possible defenses — such as removal to federal court under the Class Action Fairness Act (CAFA), forceful challenges to class certification and challenges to the pleadings under Rule 12(b)(6) — can be effective in defeating this type of class action lawsuit early in the process.
You can read the full text of her article here.
FDA Extends Food Facility Registration Deadline Until January 31
The Food and Drug Administration (FDA) has extended the deadline for food facilities to submit their registration until January 31, 2013.
Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to renew their facility registration by December 31, 2012, and every two years after that. FSMA directed that the food facility registration portal would be available starting on October 1, 2012.
However, FDA experienced a delay in implementing the biennial registration renewal for the 2012 cycle. As a result, the registration renewal portal did not become available until October 22, 2012. Food industry members requested that FDA extend the time to register in order to allow companies a full three-month window to complete the renewal requirement. In a new guidance document issued on December 12, 2012, FDA noted that it would exercise its enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.
Failure to register a facility, renew the facility registration, or update required registration information can have serious consequences. For instance, the U.S. can bring a civil or criminal action in federal court against a company that handles food without a proper facility registration. In addition, if food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food could be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered with FDA.
Along with the month-long extension, the FDA released an updated question-and-answer on facility registrations, and a shorter, simplified compliance guidance document for small businesses.
FSIS Tells Ground Poultry Producers to Reassess Their Food Safety Plans
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.
FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.
Continue Reading...Pepperidge Farm Facing Potential Class Action Lawsuit Over All Natural Claims
Although California’s Right to Know Genetically Engineered Food Act, better known as Proposition 37, failed earlier this month when put to a vote, food companies still remain vulnerable to attacks over the use of genetically engineered ingredients in their products.
Specifically, it appears that marketing a food as “all natural” when it contains a genetically engineered (GE) ingredient continues to generate class action litigation. The latest lawsuit challenging the use of the word “natural” on a product label was filed by plaintiff Sonya Bolerjack on November 6, 2012 in U.S. District Court for the District of Colorado against Pepperidge Farm, Inc. The class action complaint alleges that the company “mistakenly or misleadingly represented that its Cheddar Goldfish crackers are ‘Natural,’ when in fact, they are not, because they contain Genetically Modified Organisms (GMOs) in the form of soy and/or soy derivatives.” In particular, the plaintiff asserts that the product is not natural due to the presence of soybean oil.
The plaintiff claims that Pepperidge Farm violated Colorado’s Consumer Protection Act by engaging in deceptive trade practices; breached express warranties including that the product is natural even though it contains GMOs; and negligently misrepresented to the public through its packaging and labeling that the product is natural even though it contains GMOs.
Continue Reading...
