Food and Drug Law Access

“The White Sauce” Decision (International Custom Products, Inc. v. United States) Highlights Importance of Administrative Procedures for Food Importers

Posted in Foods and Beverages, Imports/Exports

The Court of Appeals for the Federal Circuit decision, International Custom Products, Inc. v. United States, 2015 U.S. App. LEXIS 11170 (Fed. Cir. June 30, 2015), was ten years in the making and provides a stern lesson for importers of food products to follow U.S. Customs and Border Protection’s administrative procedures carefully.  If not, importers will be out of luck and unable to file a suit against Customs in federal court.

The plaintiff ICP is an importer of products sold to processed food manufacturers, including the “white sauce” at issue.  ICP had requested a tariff classification ruling from Customs and Customs issued a ruling classifying the product under 2103.90.9060 HTSUS as “sauces and preparations therefore.”  About six years later, Customs changed the classification of the white sauce so that it should be imported under 0405.20.3000 HTSUS as “dairy spreads.”  For ICP the reclassification brought with it a duty increase of an exorbitant 2400%.  After ICP was assessed a duty bill of $28 million, the company filed a number of lawsuits against Customs.

In 2005 after Customs liquidated ICP’s entries of the white sauce with the increase, ICP decided not to pay the owing duty and neglected to file a Customs protest pursuant to 19 USC §1514.  Accordingly, when the company filed its action against the government, the CAFC upheld the Court of International Trade and eventually dismissed the case for lack of jurisdiction since the importer had not paid the owing duty nor had filed the requisite administrative protests.  The court noted that the pre-payment requirement of 28 USC §2637(a) is “a condition upon the waiver of sovereign immunity” that “must be strictly construed in favor of the government.”  Accordingly, the food importer’s failure to pay the owing duty foreclosed any attempt to invoke subject matter jurisdiction under either 28 USC §1581(a) or §1581(i).

The Court suggested to alleviate the financial burden on an importer, the importer could pay the owing duties on the first entry but then request that liquidation of the remaining entries be suspended pending the final outcome.  However, this request must be done on a timely basis.

The lessons of the “white sauce” case include keeping accurate track of owing duties and deadlines for administrative protests. Failure to do will preclude an importer from having its day in court.

FDA Extends Menu Labeling Deadline

Posted in FDA, Foods and Beverages

Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016.  In general, the Rule requires chain restaurants and other food service establishments to provide calorie information on menus and menu boards.  We discussed the specific requirements under the Rule in a previous blog post.

Restaurants, grocery stores, and food service operators were facing a tight deadline for compliance with the Rule.   Companies first needed to determine whether they were “covered establishments” under the Rule; its scope is not always been clear.  If the Rule did apply, there would be a series of steps for implementing the requirements.  For example:

  • A covered establishment would need to identify and classify the relevant “standard” menu items, and then coordinate with suppliers and third party testing organizations to collect and confirm the appropriate nutrition data. This process might require a covered establishment to update its software and information systems, so that it could organize, track, and disseminate accurate menu and nutrition information across the relevant business units and organizations.
  • Once the data was collected, a covered establishment would re-design menus or menu boards to reflect the specific labeling requirements of the rule. Because of the way the Rule defines “standard” menu items, a single re-designed menu or menu board likely would not be appropriate for all outlets of a chain; menu variations, such as regional offerings, offered at a covered establishment are generally subject to the Rule.
  • A covered establishment might also need to update training programs, oversight policies, and standard operating procedures to ensure product consistency.

Accomplishing these tasks within a year—particularly given holes in the FDA’s guidance—has proven difficult.  Since February 2015, the FDA received four separate requests for an extension to the compliance date.  After considering the questions of the stakeholders and the logistical challenges that companies face in implementing the Rule, the FDA agreed that additional time is necessary for the agency to provide further guidance and for covered establishments to come into compliance with the final rule.

Based on the FDA’s announcement, we expect that the agency will issue more guidance relating to the applicability and proper implementation of the Rule.  Thus far, the bulk of the FDA’s public guidance is contained in the Federal Register publication of the Final Rule and a Small Entity Compliance Guide.  The FDA has also provided answers on an ad hoc basis to specific stakeholders, a practice it will continue.  We will to provide updates as additional guidance becomes available.

HHS Removes Extra Hurdle for Marijuana Research

Posted in DHHS, Drugs, Scientific Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana.

Historically, in addition to the standard FDA and Drug Enforcement Administration approvals needed for research using Schedule I drugs, researchers conducting trials with marijuana were required to receive approval through a National Institute on Drug Abuse/Public Health Service protocol review process.  Last year, echoing researchers and activists, a bipartisan group of congressmen petitioned HHS to eliminate the process, asserting that it was hampering important research.

On Tuesday, in a Federal Register notice, HHS stated that the additional step was no longer required for non-federally funded research.   HHS acknowledged that PHS review overlapped in several important ways with FDA’s Investigational New Drug process. The FDA’s IND review process considers whether the research design includes good clinical and laboratory practices, whether pivotal clinical trials to support the marketing of proposed drug products are adequate and well-controlled, and the therapeutic benefits and risks to study subjects, favoring dosage forms that would provide measured and consistent dosing to patients as well as reduced exposure to potentially harmful constituents.  HHS concluded that FDA’s review was sufficient; PHS review is not necessary to support the conduct of scientifically-sound studies into the potential therapeutic uses of marijuana.  HHS anticipates that the elimination of the requirement will streamline the application and approval processes for cannabis research.  Federally-funded research will continue to require NIH review and approval.

Medical uses for marijuana and cannabis products have received significant attention in the media and drawn the attention of the public and researchers.  Although classified as a Schedule I Narcotic under the federal Controlled Substances Act, medical marijuana is currently legalized in 23 states and D.C., and other states have approved specific uses of cannabidiol, or CBD, a compound found in cannabis that has shown promise in treating certain diseases such as epilepsy.  But FDA and many medical professionals have called for more thorough testing of marijuana and cannabis to determine its safety and efficacy for treating a variety of ailments.   Indeed, on the same day as the Federal Register notice, the Journal of the American Medical Association released several articles focusing on medical marijuana and emphasizing the need to conduct additional, high-quality studies of its purported benefits.

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

Posted in FDA, Foods and Beverages, Imports/Exports

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA).  The draft guidance describes how FDA intends to determine eligibility to participate in the program, along with the benefits of participating, instructions for completing an application, and conditions under which a granted application can be revoked.

Under FSMA section 302, FDA must establish a program that provides for the expedited review and importation of food offered by importers who have voluntarily agreed to participate in the program, and establish a process for the issuance of a facility certification related to that food.  In explaining the benefits of program participation, the draft guidance describes FDA’s intention to “limit examination and/or sampling of VQIP food entries to ‘for cause’ situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP.”  Additionally, participants in the VQIP will have access to the VQIP Importers Help Desk, which will be dedicated to responding to questions and concerns of VQIP importers.

The draft guidance also describes eligibility for participating in the program.  Requirements for participation include: (1) the importer must have a 3-year history of importing food into the United States; (2) the importer cannot have imported food subject to an import alert or Class 1 recall; (3) the importer must have a current facility certification for each foreign supplier of food intended to be imported under FDA’s Accredited Third-Party Certification regulations; (4) the importer must assure compliance with Foreign Supplier Verification Program requirements and applicable seafood and juice HACCP regulations.

FDA will accept comments on the draft guidance until August 4, 2015.  Thereafter, FDA will consider comments and finalize the guidance and expects to begin accepting applications for the program in January 2018.

FDA’s Marijuana Q&A: More Questions than Answers?

Posted in Drugs, FDA

The FDA recently released its current thinking on marijuana in a variety of forms in a web-based document titled “FDA and Marijuana: Questions and Answers.”  The most notable question and answer related to whether cannabidiol (“CBD”), a non-narcotic extract of industrial hemp, can be marketed as a dietary supplement, a position that was unclear following a set of warning letters FDA released in February 2015.  FDA’s current response, pasted below, is both unqualified and possibly open to review.

“No.  Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug (an IND was filed in 2014 relative to a CBD-based epilepsy drug) for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”

FDA does not address the legality of CBD or the universe of “available evidence” that it considered in making this determination.  FDA suggests that interested parties with evidence contrary to this determination may present such information to the agency.

The definition of “marketed as” includes physically offering the article for sale at a retail establishment, listing it for sale in a catalog or price list, or through advertising or other promotion.”  CBD proponents likely will rely on historical uses of hemp in the food supply as evidence of prior marketing if evidence of CBD-specifically cannot be verified.  Whether they submit such evidence to FDA proactively or wait to see how the agency proceeds may be another question.  FDA sidestepped a Q&A on enforcement by indicating that it considers many factors and may consult with other authorities in determining whether or not to bring an enforcement action.

FDA Extends Risk-Based Medical App Approach to Medical Device Data Systems in New Guidance

Posted in FDA, Medical Devices, Regulation

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that when it comes to health IT products, FDA’s policy aims to keep unnecessary FDA regulation from impeding the progress of new technologies that offer important benefits in the delivery of health care services and in supporting individual health needs.

The agency justified its MDDS policy based on the low risk to patients MDDS products present, as well as the important role these devices can play in the digital sphere of healthcare. This most recent guidance provides further evidence of FDA’s readiness to exercise enforcement discretion to avoid the imposition of unnecessary regulatory requirements on MDDS products. In issuing the new guidance, FDA emphasized that MDDS products pose low risks to patients and have the potential to play an important role in the digital sphere of healthcare. The new guidance is consistent with FDA’s decision in 2011 to reclassify MDDS from class III (high risk) to class I (low risk) and with similar policy decisions loosening oversight on low risk devices, including the August 2014 draft guidance exempting certain class I and class II devices from premarket notification requirements.

Concurrently, FDA updated its mobile applications guidance to be consistent with its current position regarding MDDS. FDA’s updated Mobile Medical Applications Guidance, originally issued in June 2013, explains FDA oversight of mobile apps is risk-based and limited to those apps that, depending on functionality, could cause harm to patients if they failed to work properly.

U.S.-China Commission Study Provides Policy Recommendations to Help U.S. Exporters Compete in China’s Growing Medical Device and Pharmaceutical Market

Posted in Drugs, Imports/Exports, Medical Devices

A recent report issued by the U.S.-China Economic and Security Review Commission (USCC)[1] highlights why the Chinese market is central to the business strategy of many U.S. companies that manufacture and market pharmaceuticals, medical devices, and other healthcare products.  The Congressionally-mandated report[2], issued in November 2014, addresses in detail the opportunities and challenges surrounding access to China’s growing medical device and pharmaceutical market.  It also provides specific recommendations for Congress to help U.S. companies gain access and compete.

The report’s key findings and conclusions were based, in part, on a April 2014 hearing in which the USCC examined China’s healthcare sector, drug safety, and U.S.-China trade in medical products and biopharmaceuticals.[3]  Hearing witnesses included, among others, the U.S. Food and Drug Administration’s (FDA) country director for China, senior executives for AdvaMed, PhRMA, and healthcare policy experts from the Council on Foreign Relations and the Asia Health Policy Program at the Shorenstein Asia-Pacific Research Center of Stanford University.

Regarding China’s healthcare sector, several report findings demonstrated the potential for significant growth and commercial opportunities in the medical products market.  Such key findings include:

  • China is undergoing an “epidemiologic and demographic transition” that is exploding China’s demand for healthcare as China’s population is ageing, contracting more chronic diseases, urbanizing, and getting wealthier.
  • Biopharmaceutical products represent a growing net export from the United States to China, increasing by 28 percent every year for the last ten years to $1.4 billion in 2013.
  • China’s healthcare spending is projected to increase from $357 billion in 2011 to $1 trillion in 2020.  China’s over-the-counter and branded generic market is forecast to expand from $23 billion in 2010 to $369 billion in 2020.  That would make China the second-largest pharmaceutical market after the United States.

According to the report, from the vantage point of U.S. companies that manufacture and market drugs, medical devices, and other healthcare products for the U.S. and global markets, the commercial opportunities in China relate primarily to the research and manufacturing capabilities of the companies doing business in China.  For example, access to these facilities would allow drugs, medical devices and components to be studied and sourced in China relatively inexpensively.

U.S. companies’ ability to tap into these areas of potential growth is complicated, however, by numerous market access barriers.  The report also found that U.S. drug and device makers continue to have restricted market access and limited opportunities to market and sell their products in China.  Some specific barriers, as reported, include:

  • U.S. company concerns about being targeted by enforcement actions in view of China’s recent anticorruption drive, discriminatory use of its antimonopoly law, excessive data transfer and clinical trial requirements for new drug approval.
  • Deficiencies in China’s intellectual property laws, and state interference in tendering, pricing, and reimbursement, which in combination can cause delays up to eight years for state-of-the-art U.S. drugs making them prohibitively expensive for many Chinese patients. 
  • Proposed amendments to China’s Medical Device Law, published in March 2014, which could impose hundreds of new requirements on foreign device markets, including indigenous standards for serial number tracking.

Recognizing the importance of the Chinese market to U.S. medical and pharmaceutical producers, the USCC made specific recommendations to Congress aimed at reducing barriers so  U.S. companies can expand their business.  For example, the USCC recommended that Congress:

  • Adopt measures to make greater use of “track and trace” technology, by urging U.S. negotiators to demand that China harmonize with internationally recognized standards for medical devices and active pharmaceutical ingredients, and making the use of serial numbers mandatory at all times.
  • Direct the Office of the U.S. Trade Representative (USTR) to review the interest of U.S. healthcare goods and services providers in the Chinese market, Chinese market barriers, and opportunities to promote human health in China in ways that promote U.S. consumer and business interests.

As U.S.-China healthcare and pharmaceutical trade grows, the USCC recommendations may play a significant role in related policy debates in 2015.  Many Chinese healthcare industry policies and measures could violate international trade and investment rules of the World Trade Organization (WTO), and could be addressed in formal WTO dispute settlement, WTO Government Procurement Agreement (GPA) negotiations, U.S.-China bilateral investment treaty (BIT) negotiations, and various U.S.-China trade and economic dialogues, all which would be led by USTR.

KDW’s International Trade and Government Relations Groups specialize in advocacy before USTR and Congress on international trade and market access issues, supply chain compliance, and anticorruption laws.  If you have any questions concerning the USCC’s report, recommendations, or other related issues, please contact Jennifer McCadney ( for further information.

[1] USCC is charged with monitoring and providing recommendations to Congress regarding the national security implications of U.S.-Sino trade and economic relations.

[2] Available at:   See pages 127-182 and 229.

Sunscreen Innovation Act Changes FDA Review Process for More Than Just OTC Sunscreens

Posted in Drugs, FDA

On November 26, 2014, the President signed into law the Sunscreen Innovation Act (Pub. L. No. 113-195).  The Act is primarily intended expedite FDA procedures for approving new sunscreen active ingredients and ingredient blends for use in nonprescription sunscreen products under the Federal Food Drug and Cosmetics Act, and address the current backlog of sunscreen ingredient applications pending at FDA.  The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in 1999.  Since that time, eight new sunscreen applications have been filed and are still awaiting review.

Importantly, the Act also sets forth a new framework for FDA to expedite similar approval processes for nonprescription drugs other than sunscreen active ingredients under FDA’s existing time-and-extent application (TEA) process.  Sunscreens and other OTC drug products that are currently marketed will not be affected by the provisions of the Act.

Click here to read the complete advisory.

FDA Issues Final Rules Prescribing Broad Labeling Requirements for Menus and Vending Machines

Posted in FDA, Foods and Beverages, Regulation

The FDA recently released two long-awaited final rules that establish detailed requirements for calorie labeling on menus and menu boards and vending machines. Promulgated pursuant to provisions of the Affordable Care Act (ACA) that amended the Federal Food, Drug & Cosmetic Act, the final rule broadly defines “similar retail food establishments” such that many non-restaurants including grocery stores, movie theaters, and entertainment venues will also be subject to the detailed labeling requirements. The rule also prescribes specific technical requirements for the size and color of the font that will be used in the required disclosures.

Menu Labeling Final Rule

Under the final rule, covered food establishments must include three separate disclosures on all menus and menu boards: (1) calorie information for standard menu items and other specified items, (2) the statement that “2,000 calories a day is used for general nutrition advice, but calorie needs vary,” or a substitute statement for children’s menus and menu boards, and (3) a statement that written nutrition information is available upon request. Regarding the third requirement, covered establishments must make the following information available upon request: total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein.

The covered establishment must have a reasonable basis for all nutrient declarations, which the rule specifies would include use of nutrient databases, cookbooks, laboratory analyses, or “other reasonable means.” Along with each specific labeling requirement, the final rule imposes unique format requirements for the prescribed statements. For instance, the statement declaring the number of calories must be: (1) listed adjacent to the name or the price of the associated standard menu item, (2) in a type size no smaller than the type size of the name or the price of the associated standard menu item, whichever is smaller, (3) in the same color, or a color at least as conspicuous as that used for the name of the associated menu item, and (4) with the same contrasting background or a background at least as contrasting as that used for the name of the associated menu item.

Other notable options of the final rule include:

  • The variety of establishments covered as “restaurant or similar retail food establishments.” The rule defines the universe of covered establishments, in effect, by whether they provide “restaurant-type food,” except that it excludes schools as defined under existing regulations. “Restaurant-type food,” in turn, is defined to include any food that is: (1) usually eaten on the premises, while walking away, or soon after arriving at another location, and (2) either served at the establishment for immediate consumption, or processed and prepared primarily at the establishment and ready for human consumption. The result is that the same requirements will apply to fast food restaurant meals, grocery store salad bars, and convenience store hot dogs, amongst other items. Foods that would not be covered include those eaten over several occasions or stored for later use (e.g., a whole cake) or foods typically intended for more than one person to eat that may require additional preparation (e.g., deli meats and cheeses).
  • Applicability to alcoholic beverages. While the proposed rule would have exempted alcoholic beverages from the labeling requirements, the final rule includes requirements for alcoholic beverages that are standard menu items. The rule explains FDA’s conclusion that, within the menu context, “providing nutrition information for an alcoholic beverage for which other labeling is also regulated by TTB [the Alcohol and Tobacco Tax and Trade Bureau] provides the same public health benefit as providing the information for other foods.” The final rule, however, does exempt alcoholic beverages that are foods on display and not self-service foods (i.e., drinks ordered by consumers but not on the standard menu).
  • Substantiation documentation. The final rule provides that covered establishments must provide to FDA, within a reasonable period of time upon request, information substantiating nutrient values including the method and data used to derive these nutrient values. The rule clarifies what FDA will consider to be sufficient information to substantiate nutrient values. Notably, FDA did not cite any specific recordkeeping authority in promulgating this requirement.

State and local governments are prohibited from imposing requirements that are not identical to those imposed by the final rule. Covered establishments will have one year from December 1, 2014 to comply with the final rule.

Vending Machine Final Rule

The final rule that applies to vending machine operators similarly imposes strict calorie labeling requirements. Under that final rule, covered vending machine operators must post calorie information either on a sign close to the article of food or the selection button. The calorie declarations may be adjacent to, rather than in or on the vending machine, provided they are visible at the same time as the food, name, price and selection button. The sign must provide declarations for all foods offered by that particular vending machine, such that operators will need to ensure that the signs are up-to-date with the latest declarations.

The rule applies to vending machines that are operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine is defined to include machines that dispense a variety of foods, including packaged foods, packaged beverages, hot or cold cup beverages, or bulk foods (e.g., nuts or candies). Covered operators must also disclose on or adjacent to the vending machine their contact information, including the operator’s name, telephone number, and mailing or email address. FDA cites the need to contact the operator for enforcement purposes as the reason for this requirement.

While the menu rule will become effective one year from publication, vending machine operators will have two years from December 1, 2014 to comply with the rule.

Not So “COOL”: WTO Meat Labeling Dispute Moves One Step Closer to Canadian and Mexican Retaliation Against U.S. Exports

Posted in Imports/Exports, USDA

On October 20, 2014, a World Trade Organization (“WTO”) Compliance Panel ruled that the U.S. Department of Agriculture’s (“USDA’s”) revised country-of-origin labeling (“COOL”) regulations for meat are inconsistent with U.S. obligations under the WTO.  The panel found the amended rulings – which were revised to include information about where each of the production steps, including birth, slaughtering and packaging, take place – actually increased the discriminatory effect against imported livestock from Canada and Mexico.

While the United States Trade Representative decides what steps it will take in response to the ruling – including filing an appeal or seeking a settlement – industry groups are calling for the U.S. to bring COOL regulations into compliance before Canada and Mexico are permitted to seek compensation in the form of applying a retaliatory surtax – up to 100 percent – against certain U.S. commodities.  No action has been authorized as of yet, however, Canada and Mexico have each indicated specific U.S. products that could be subject to retaliation – including numerous food products, steel products and consumer goods, such as jewelry and certain furniture items.

KDW’s International Trade group will continue to monitor COOL developments related to compliance with or changes to the current COOL regulations, as well as updates on retaliation against specific U.S. exports. Please consider sharing this advisory with your clients and contacts who import meat products (beef and pork) that are subject to COOL, or export products that are the target of retaliation (a list is provided in the advisory).

Click here to read the complete advisory.