President Obama signed into law the Food Safety Modernization Act (FSMA) nearly three years ago. After significant delays, the FDA has made significant progress this year towards implementing this act and published five key proposed FSMA implementing regulations. These proposed regulations and related FDA enforcement policies will have far-reaching implications for how food for both human or animal consumption is regulated in the United States. Companies need to be well informed about the impact FSMA may have on their businesses and should be actively engaged in the policy development process to help ensure that FDA receives the stakeholder input it needs.
To learn more and see a breakdown of these five proposed regulations, please click here.
The 2nd District Court of Appeals agreed with the lower court’s decision that no reasonable consumer would be misled into thinking that a product labeled as spreadable butter with canola oil was not 100% butter. Mary Simpson sued Kelley Drye clients Kroger Corp. and Challenge Dairy Products alleging that the labeling of Challenge’s “Spreadable Butter With Canola Oil” product was false and misleading because the label used the word “butter” to name a food that is not a 100% butter product.
Kelley Drye moved to dismiss the plaintiff’s claims on the grounds that they were pre-empted by the labeling requirements of the Food Drug & Cosmetic Act and the complaint was dismissed, with prejudice, by Judge Barbara Scheper of the Los Angeles County Superior Court in May 2012.
Simpson appealed, but in a unanimous decision by the three-judge panel, the appeals court ruled that Simpson’s claims were not plausible and that no reasonable consumer would have been misled by the labeling of the Spreadable Butter With Oil Products.
Still buying imports of dubious foreign origin from unrelated U.S. importers? Consider the case of Groeb Farms, Inc., which recently accepted criminal responsibility for fraudulently entered Chinese honey that had avoided $79 million in duties – despite not being directly involved in the honey’s importation.
The takeaway: Not being the importer of record for fraudulently entered goods does not insulate a “knowing” downstream buyer from criminal liability for that fraud.
In a new article published in The Metropolitan Corporate Counsel, partner Michael J. Coursey explains that the government now expects that all U.S. users and distributors of imports have already implemented and are maintaining rigorous supply chain procedures, and companies that haven’t done so face a heightened risk. Click here to read the article, “Honeygate II Highlights Supply Chain Risks For U.S. Buyers Of Imported Goods.”
FDA announced this week the availability of the draft guidance, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The draft guidance would implement sections 701 and 702 of the Food and Drug Administration Safety and Innovation Act (FDASIA) by specifying that domestic and foreign drug manufacturers should use the Data Universal Numbering Systems (DUNS) number for a drug establishment’s UFI.
Sections 701 and 702 of FDASIA require domestic and foreign drug establishments to register annually with FDA between October 1 and December 31 and requires the registration to include a UFI to be specified by FDA. The draft guidance explains that FDA has been using DUNS numbers as registration numbers for drug establishments since the implementation of electronic drug registration and listing. DUNS numbers are assigned and managed by Dun and Bradstreet and are available free of charge to all drug establishments. Under the draft guidance, establishments are instructed to contact FDA if they desire to use an alternate UFI.
While section 703 of FDASIA requires the use of the same UFI system to identify excipient manufacturers in product listings, FDA indicated that this draft guidance would be limited to UFI use under sections 701 and 702 and not address section 703.
United States District Judge Phyllis Hamilton has denied a request from the FDA for additional time to promulgate standards for preventing intentional adulteration of food, stating that although she is sympathetic to the FDA’s position, “the dispute here is between the FDA and Congress.”
The order is the latest development stemming from an August 2012 lawsuit filed in the Northern District of California by the Center for Food Safety (CFS) alleging that the FDA’s failure to meet statutory deadlines in implementing the Food Safety Modernization Act (FSMA) constituted unlawfully withheld and unreasonably delayed agency action under the Administrative Procedure Act (APA) and FSMA. CFS sought injunctive relief requiring the FDA to immediately promulgate all FSMA regulations.
The court held that the FDA’s failure to meet the statutory deadlines violated the APA and ordered CFS and the FDA to come up with a new timetable. The parties were unable to reach an agreement so they each submitted different schedules. The court established its own schedule, ordering that all proposed rules be published by November 30, 2013, all comment periods closed by March 31, 2014, and all final rules published by June 30, 2015. This most recent order grants the FDA an additional 60 days for the proposed regulations implementing the Sanitary Food Transportation Act (STA).
The Food and Drug Administration (FDA) has published its long awaited final rule defining “gluten-free” labeling requirements. Under the final rule, companies may choose to promote foods using “gluten free” labeling claims provided that the labeled foods qualify under the definition prescribed by FDA in the final rule. Under FDA’s final rule, “gluten-free” is defined to mean that the labeled food contains no ingredient that:
- Is a gluten-containing grain OR
- Is derived from a gluten-containing grain that has not been processed to remove the gluten OR
- Is derived from a gluten-containing grain that has been processed to remove the gluten such that gluten levels do not exceed 20 parts per million.
In no case may foods containing levels of gluten that exceed 20 parts per million be labeled as “gluten free.”
Foods that are inherently free of gluten may be labeled to promote the gluten-free attribute, provided that the claim employs the “gluten-free” claim in a manner that refers to all foods of the same type (e.g. “milk, a gluten-free food”).
Producers of dietary supplements and food intended for human use producers will have until August 5, 2014 to comply with the rule.
In the final rule, the FDA also stated that it intends to exercise enforcement discretion regarding gluten-free beers that are made from either a non-gluten-containing grain or a gluten-containing grain that has been processed to ensure that gluten levels in the finished beer do not exceed 20 parts per million. In addition, the FDA intends to promulgate a separate rulemaking for fermented or hydrolyzed foods.
The Food and Drug Administration (FDA) has announced its intention enter a cooperative agreement with the World Trade Organization’s (WTO) Standards and Trade Development Facility (STDF). Under the cooperative agreement, the FDA will award STDF a grant of $750,000 to support STDF activities for one year, with the possibility of additional support for four more years.
Under § 305 of the Food Safety Modernization Act, the FDA was tasked with developing a plan to expand the technical, scientific, and regulatory food safety capacity of foreign governments, and their respective food industries, from which foods are exported to the United States. The grant to STDF is part of the FDA’s efforts to comply with this obligation.
The STDF is a global partnership that supports developing countries in building their capacity to implement international sanitary and phytosanitary (SPS) standards, guidelines and recommendations. The STDF provides capacity evaluation tools, shares best practices, and provides financial assistance to developing countries for the purpose of facilitating trade.
The Food and Drug Administration (FDA) has issued a draft guidance document entitled Arsenic in Apple Juice: Action Level in which it announces an action level of 10 ppb for inorganic arsenic in apple juice. This action level is consistent with the 10 ppb limit for arsenic set by the Environmental Protection Agency for drinking water. The FDA will consider the inorganic arsenic action level, among other things, when considering whether to bring enforcement action in any particular matter.
Historically, total levels of arsenic in apple juice have been below 10 ppb. However, the FDA has identified samples with higher levels in recent years. Possible sources of inorganic arsenic include the following:
- Processing aids
- Prior use of arsenic-based pesticides on land currently used for apple orchards
- Current use of arsenic-based pesticides in other countries
- Naturally high levels of arsenic in soil or water
- Atmospheric deposition from industrial activities
- Water used by manufacturers to dilute concentrate to prepare ready-to-drink juice
The FDA will analyze samples of apple juice found to contain more than 10 ppb of total arsenic in order to determine the level of inorganic arsenic. If more than 10 ppb of inorganic arsenic are found, such finding will be a factor in the FDA’s decision to bring enforcement action.
The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the food additive regulations in 21 C.F.R. § 175.300 to no longer provide for the use of BPA-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. Under 21 C.F.R. § 171, et. seq., the petitioner may propose that FDA amend a food additive regulation if the petitioner can demonstrate that there are ”old uses abandoned” for the relevant food additive.
BPA-based epoxy resins are formed by the reaction of 4,4′-isopropylidenediphenol (i.e., BPA), and epichlorohydrin. Under current FDA policy, BPA-based epoxy resins may be safely used as the food-contact surfaces of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the prescribed conditions of § 175.30. As followers of the agency’s position on BPA know, FDA currently considers BPA safe for many food contact uses and issued its most recent justification for this position in March 2013, available here.
As of July 2012, however, FDA banned BPA from use in infant and toddler products such as baby bottles and sippy cups. Like the agency’s decision last week, FDA’s decision regarding baby bottles and sippy cups was made in response to a petition filed by the American Chemistry Council, which was also based on industry abandonment.
The final rule became effective on July 12, 2013.
The American Meat Institute (AMI), along with seven other meat and livestock organizations representing the United States, Canada, and Mexico, filed an action this week challenging USDA’s recent mandatory country of origin rule. Issued by the Agricultural Marketing Service (AMS) on May 24, the final rule would revise existing regulations to require covered products to include labels individually designating the country where the animal was “born,” the country where the animal was “raised,” and the country where the animal was “slaughtered.” The regulation would also prohibit the currently widespread industry practice of processing animals together that have been born or raised in different countries.
The complaint alleges that the rule should be invalidated on three distinct grounds. First, AMI argues that the regulation violates the First Amendment of the U.S. Constitution by impermissibly compelling speech. Under the First Amendment, the government cannot compel speech unless that speech advances a substantial government interest and the regulation is no more extensive than necessary. AMI argues that the “Revised Regulations do not serve any governmental interest, let alone a substantial one.” Along those lines, the complaint explains that AMS did not justify the regulation with a health or safety rationale and that courts have held that consumer curiosity alone is not a substantial government interest in of itself.
Second, the complaint argues that the rule exceeded AMS’s authority granted by the Food, Conservation, and Energy Act, which specifically defined “country of origin” for specific types of meat. Because those definitions do not address where the source animal was born and raised, the complaint alleges that AMS exceeded its authority in requiring labels to bear those distinctions. AMS was also not authorized to restructure the production, distribution, and packaging systems for meat production, which the prohibition against commingling allegedly does, according to the complaint.
Third, the complaint alleges that AMS violated the Administrative Procedure Act by failing to respond to evidence and analysis supporting an alternative approach. The revised regulation was issued in response to a 2012 World Trade Organization (WTO) ruling that existing regulations violated the WTO Agreement on Technical Barriers to Trade by imposing burdens on the supply chain that discriminated on livestock exports from Canada and Mexico. According to the complaint, the revised regulations would only exacerbate discrimination against livestock exports from Canada and Mexico and, therefore, more flagrantly violate the WTO Agreement.
We will continue to monitor the case and post updates here.