On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same requirements apply to certain substances – i.e., non-dietary ingredients – added to dietary supplements. According to FDA, the document was spurred by the growth of food and beverage products that contain novel substances, such as added botanical ingredients or their extracts, that may be unapproved food additives, or contain additives in excess of their traditional use levels.
The guidance reiterates the requirements for additives in conventional foods: if a substance is not generally recognized as safe (“GRAS”) for its intended use in food, it is a food additive that must receive premarket approval before it can be used. The use of an unapproved food additive will render a food or beverage adulterated. FDA is concerned, however, that the new substances added to conventional foods and beverages are not GRAS for their intended use and are not being used in accordance with a food additive regulation. Additionally, the use of traditional substances at much higher levels and in new types of foods may not be safe.
The guidance also emphasizes that, although dietary ingredients used in dietary supplements are exempt from the food additive definition (and requirements), other, non-dietary ingredients such as binders and fillers are not exempt, and must be used in accordance with a food additive regulation or be GRAS for their intended use.
FDA recently issued a new proposed rule under the Food Safety Modernization Act (FSMA) that would require domestic and foreign food facilities to identify and implement focused mitigation strategies to reduce the risk of intentional adulteration. The rule is scheduled to be published tomorrow in the Federal Register and interested parties will have until March 21, 2014 to submit comments.
Under the proposed rule, non-exempt food facilities would be required to prepare and implement a written food defense plan, including actionable process steps, focused mitigation strategies, procedures for monitoring, corrective actions and verification. Based on results of vulnerability assessments conducted using the CARVER+Shock methodology, the proposed rule identifies four categories of “key activity types,” which result in a facility being considered at a high risk for intentional adulteration. Those activity types are bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities.
The key activity types are intended to serve as a guide, though not a replacement for, a facility’s vulnerability assessment. As with other proposed rules implementing FSMA, the rule proposes staggered compliance dates based on the size of the facility – ranging from one to three years from publication of the final rule.
The proposed intentional adulteration rule is the sixth proposed rule by FDA implementing FSMA. We will continue to monitor developments regarding this and other FSMA rules here.
On Monday, FDA announced a new proposed rule that would amend the 1994 TFM for OTC antiseptic drug products. The change would require companies that sell antibacterial soaps and body washes that are labeled “antibacterial” or “antimicrobial” to prove through a “controlled clinical outcome study” that their products prevent the spread of illness better than ordinary non-bacterial cleansers without such labeling – evidence establishing the germ-killing properties of the antiseptic ingredients used in product formulations would not be sufficient to establish the effectiveness of these products.
The FDA proposal responds in part to new scientific data that has emerged since the 1994 TFM was issued that suggests that there may be risks associated with long-term, daily use of antibacterial soaps that may outweigh their benefits. For example, FDA cites data suggesting that the antiseptic ingredients, triclosan (used in liquid soaps) and triclocarban (used in bar soaps), which can be absorbed through the skin, may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects. In view of such potential risks, the FDA proposal is designed to require manufacturers to provide more robust scientific evidence to FDA to demonstrate the safety and effectiveness of antibacterial soaps.
The proposal would cover antibacterial soaps and body washes for consumer use, but would not affect such antiseptic products as hand sanitizers, sanitizing wipes, and antibacterial products used in healthcare settings or the food industry.
The new rule will be open for public comment until June 15, 2014 and then subject to a 60-day rebuttal period. EPA also regulates antimicrobial chemicals as pesticides, and the two agencies are coordinating their regulatory activities in this area.
Recently, H&M USA, an importer of periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief when the company’s efforts to resolve an unexpected import detention through FDA’s administrative process proved unsuccessful. The FDA issued a Notice of Refusal, alerting the company that it had failed to submit end-use documentation, and thus must export or destroy the goods under Customs supervision within 90 days. H&M responded to the Notice of Refusal by filing a lawsuit against FDA in the Eastern District of New York challenging the agency’s actions both in detaining and later refusing entry to the importers bulk shipment of 20,000 kilograms of API acetaminophen destined for use in a nonprescription pain reliever product that would be sold by H&M’s customer, a manufacturer of pharmaceuticals that markets finished drug products under the label Rugby Laboratories, Inc. The complaint filed by H&M in the case alleges that in refusing to allow H&M’s lawfully labeled API acetaminophen shipment to be imported into the United States, FDA has engaged in unlawful conduct which violates the requirements of the Administrative Procedure Act and misapplies FDA’s own drug labeling regulations.
According to H&M’s complaint, the conflict started in early August 2013 when the U.S. Customs and Border Protection (CBP), at the direction of the FDA, detained 20,000 kilograms of API acetaminophen imported by H&M into the United States on the grounds that the shipment lacked adequate directions for use. Over the next several weeks, representatives of H&M and its customer communicated with the FDA Compliance Officer, providing information aimed at establishing that the detained shipment of API acetaminophen is lawfully labeled in accordance with the exemption FDA established under 21 C.F.R. § 201.122 for bulk drug products that are “intended for processing, or use in the manufacturer of another drug.” According to the H&M complaint and related information filed in the case, an official with FDA’s Compliance Branch stated that FDA refused entry to the API acetaminophen shipment based on the conclusion that the shipment does not qualify for the bulk labeling exemption H&M relied upon because the API acetaminophen shipment “was for future/inventory use by the contract manufacturer, which is not permitted” and because documentation confirming the end use for which the API acetaminophen was destined was submitted “from only one of the contract manufacturer’s customers.” The bases for these apparent findings are unclear.
Earlier this month, the court granted H&M’s request for a temporary restraining order, and also ordered that the Government appear before the court to show cause as to why a preliminary injunction should not be issued against the FDA. Subsequently, prior to the scheduled date of appearance, the Government and H&M came to an agreement in principle to toll the export and destruction of the API acetaminophen shipment in question while the FDA reassesses the shipment. The court will likely endorse this plan of action, but whether the results of the FDA’s review will be in H&M’s favor remain to be seen.
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.