The Humane Society of the United States (HSUS) has filed a complaint with the FTC against a national egg marketer alleging false animal welfare advertising.
- Animal raising claims, such as “pasture raised” have come under increased scrutiny in recent years. For example, as previously discussed on this blog, the term “pasture raised” was the subject of a recent complaint filed against an egg retailer alleging that its “pasture raised” eggs are actually being sourced from supplier farms that provide limited indoor space or outdoor access for its birds, thereby falling short of consumer expectations.
- On October 14, 2016, the Humane Society of the United States (HSUS) filed a complaint with the Federal Trade Commission alleging that National Pasteurized Eggs, marketed in grocery stores nationwide, is misrepresenting how its eggs are produced. The complaint alleges that the egg cartons prominently depict lush open pastures, a red barn and free-roaming hens despite eggs in those cartons being sourced from hens living in battery cages such that the birds cannot “spread their wings, venture outside, breathe “fresh” air, or see natural sunlight”.
- This latest case represents yet another example of the ongoing regulatory and litigation risk faced by food companies responding to increasing consumer demand for “clean label” foods, particularly in cases where a marketing claim is not federally defined.
Responding to industry complaints, USDA appears to have dropped GMO consumer use study.
- As previously discussed on this blog, on July 29, President Obama signed S. 764 into law, establishing a federal framework for the labeling of genetically modified (GM) foods and food ingredients. This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bioengineered foods by July 2018. As also covered on this blog, last month, the Agency issued a request for information (RFI) to inform the design of two studies intended to assist the Agency with developing mandatory disclosure requirements for bioengineered foods. One study would identify potential nationwide technological challenges that may impact whether consumers would be able to rely on electronic or digital links on food packages, and the other would evaluate the likelihood consumers will use electronic or digital disclosures.
- In an October 19, 2016 press release announcing the solicitation for vendors to submit proposals to conduct a Study on the Electronic or Digital Link Disclosure, the Agency appears to have dropped the consumer use study. The press release notes that, based on comments received during the RFI, the Agency has revised its requirements for what the study will entail, “including modifying the study design to align more closely with the factors identified in the statute.” The proposals for the study on technological challenges are due on November 22, 2016.
- USDA’s decision to drop the consumer use study follows industry complaints that the consumer study was unnecessary and outside the scope of the law’s requirements. We will continue to keep you apprised of the latest developments regarding USDA’s implementation efforts of this new federal GMO labeling law.
The International Poultry Council has pledged to tackle antibiotic resistance in food producing animals. (subscription to meatingplace.com required)
- As previously covered on this blog, for years, FDA, USDA, and various stakeholders have grappled with how to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals. This issue has now become a hot topic on the global stage. For example, on September 21, 2016, the United Nations held a ministerial meeting on antimicrobial resistance.
- Most recently, during a conference last week in Estoril, Portugal, the International Poultry Council, which represents about 80 percent of the world’s poultry production, and about 95 percent of global trade in poultry meat, pledged to tackle antibiotic resistance in food producing animals. IPC President Jim Sumner (also president of the USA Poultry & Egg Export Council), noted that the “IPC recognizes the need for collaborative efforts among governmental organizations, non-governmental organizations and the poultry sector to minimize the development and transfer of antibiotic resistance.”
- It remains to be seen whether and how the IPC’s position will affect producers’ efforts to work with their respective governments to reduce the use of medically important antimicrobials in food animals.
The organic industry, led by the Organic Trade Association, has called for federal policies to ensure “organic” always means “organic”.
- Organic production in the U.S. is regulated by the U.S. Department of Agriculture’s National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA) (Public Law 101-624, Nov. 28, 1990). The national standards developed by the NOP for organically-produced agricultural products are designed to assure consumers that products with the USDA organic seal meet consistent, uniform standards.
- Yesterday, the Organic Trade Association (OTA) issued a press release calling for federal policies to strengthen the integrity of the organic seal for all products branded as organic. The OTA specifically noted that while consumer trust in organic foods is high, the same is not true for non-food products such as household cleaners or personal care products. This press release came in advance of a joint Federal Trade Commission (FTC)/USDA roundtable being held today regarding consumer perception of organic claims for non-food products. A main goal of today’s roundtable is to discuss whether the FTC needs to issue further guidance to makers of non-food products that use the organic claim or term without reference to the USDA Organic seal, whether they refer to another organic certification program or no certification at all.
- It remains to be seen whether and to what extent industry’s efforts to strengthen consumer trust of “organic” will result in the FTC exercising its consumer protection authority regarding organic claims on products that fall outside of USDA’s purview.
A leading meat producer has been sued over “natural” claims on deli meats. (subscription to Law360 required)
- Challenges to “natural” claims continue, with many cases targeting “natural” claims for products containing synthetic ingredients or preservatives. As previously covered on this blog, FDA is considering whether to regulate the term “natural”. USDA, which regulates meat and poultry, currently has in place an informal policy on “natural” which permits USDA-regulated products to be labeled “natural” when the product does not contain any artificial flavor or flavoring, coloring ingredient, chemical preservative (as defined in 21 C.F.R. 101.22), or any other artificial or synthetic ingredient; the policy also provides that the product and its ingredients cannot be more than minimally processed.
- On October 11, 2016, a class action lawsuit was filed against Hormel Foods Corp. alleging that it includes synthetic ingredients and preservatives in deli meat labeled as “100% Natural” or “No Preservatives”. This lawsuit comes on the heels of another “natural” lawsuit filed against Hormel by the Animal Legal Defense Fund, Public Justice, and the Richman Law Group filed in the District of Columbia Superior Court on June 30, 2016. That lawsuit alleges that certain of the company’s natural products are derived from food animals treated with additives, hormones and antibiotics. Hormel contends that its “natural” branded products are produced, labeled, and marketed in conformance with all applicable laws and regulation.
- Assuming the products at issue do not run afoul of current USDA policy on “natural”, the lawsuit may face an uphill battle if the claims and labels themselves were specifically approved by USDA.
Furfuryl alcohol was recently added to California’s Proposition 65 list of carcinogens, effective September 30, 2016.
- Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, prohibits knowingly exposing any individual to a listed chemical without first providing a “clear and reasonable warning” to such individual.
- Effective September 30, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) added furfuryl alcohol (CAS No. 98-00-0) to the list of chemicals known to the State to cause cancer under Proposition 65. Furfuryl alcohol was listed under the authoritative bodies listing mechanism based on the U.S. Environmental Protection Agency (EPA) 2014 report, “Cancer Assessment Document, Evaluation of the Carcinogenic Potential for Furfural and Furfuryl Alcohol.” According to the CDC, furfuryl alcohol is found in processed natural foods, including the oils of chicory and roasted coffee, in yellow leaf tobacco, and in heated skim milk, usually as result of processing.
- Affected stakeholders should ensure compliance with applicable clear and reasonable warnings required under Proposition 65. Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65. Should you have any questions, please feel free to email us at firstname.lastname@example.org.
FDA has released a Q&A document regarding the Agency’s expectations going forward for FSMA compliance now that the first set of major FSMA compliance dates have arrived.
- The first major FSMA compliance dates arrived on September 19, 2016 for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). In short, larger businesses are now subject to certain new standards. In particular, human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs), and animal food facilities must meet CGMPs.
- Yesterday, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addressed questions that have been raised about what the next few months will look like. Highlights of the Q&A document include:
- reiterating that the first year of compliance will affect the larger businesses, generally those with 500 or more employees;
- underscoring the importance of documenting all steps taken to proactively prevent against food contamination events; and
- indicating that the Agency will initially be focused on education, i.e., working with the food industry “to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.” That being said, the Agency indicates that it would certainly take swift action, when necessary, to protect public health.
- Stakeholders subject to FSMA should make every effort to be well-versed in the various regulatory obligations imposed by FSMA.
The Natural Products Association has asked FDA to extend the comment period deadline concerning the regulatory status of vinpocetine until September 6, 2017.
- Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant. Dietary supplements containing vinpocetine as a dietary ingredient have been on the market for roughly 20 years. From a regulatory standpoint, the Agency had previously accepted five 75-day New Dietary Ingredient Notifications (NDINs) for vinpocetine and did not raise any concerns about the ingredient’s status when evaluating those submissions. In recent years, however, vinpocetine has been the subject of some controversy. FDA took note and, as previously covered on this blog, on September 7, 2016, FDA requested public comment (by November 7, 2016) on the regulatory status of vinpocetine. In requesting public comment, the Agency stated that it has “tentatively concluded” that vinpocetine is not eligible to be marketed as a dietary ingredient.
- Earlier this month, the Natural Products Association requested that FDA extend the comment period deadline to September 6, 2017, noting that industry will need this “time to conduct additional research, as well as identify the extent to which these changes might impact manufacturers, distributors and consumers” of these products.
- Given the somewhat unusual, but not unprecedented move by the Agency in revisiting the regulatory status of vinpocetine, coupled with its widespread use (in as much as 350 brands according to the Natural Medicines Comprehensive Database), it would not be surprising if FDA extended the comment period. However, it remains to be seen whether the Agency will agree to grant the substantial amount of additional time NPA requested.