Food and Drug Law Access

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

Posted in FDA, Foods and Beverages, Product Labeling & Marketing

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register notice and subsequently has been included in the Code of Federal Regulation (21 CFR 104.20) even though the policy was never subjected to notice and comment rulemaking and does not qualify as a legally binding “rule,” but rather as agency “guidance.”  From the beginning, FDA’s fortification policy has been designed to discourage the “indiscriminate addition of nutrients to food” and “establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods.”

The new Guidance restates and elaborates upon the food fortification principles stated in the established 1980 fortification policy.  The Guidance does not reference a specific provision of the Federal Food, Drug & Cosmetic Act (FDCA) as the basis for its authority to maintain or enforce the fortification policy, but signals the agency’s readiness to rely on the misbranding provisions of the statute in taking enforcement actions against fortified snack foods. Notably, the “Statement of Purpose” for FDA’s established fortification policy in 21 CFR 104.20(a) attempts to draw a link between the fortification policy and FDA’s authority to prevent deceptive or misleading claims under its misbranding authority without elaboration or support:  “[R]andom fortification of foods could result in over- or under fortification in consumer diets and create nutrient imbalances in the food supply.  It could also result in deceptive or misleading claims for certain foods.”

The new Guidance further addresses the potential for “inappropriate” fortification to result in misbranding violations in the context of fortified snack foods and suggests that fortification of “snack foods could mislead consumers to believe that substitution of naturally nutrient dense foods with fortified snack foods would ensure a nutritionally adequate diet.”   The new Guidance goes on to suggest that “fortification of such snack foods would disrupt public understanding about the nutritional value of individual foods and thereby promote confusion among consumers, making it more difficult for them to construct diets that are nutritionally adequate.”  The new Guidance does not cite any quantitative or qualitative research for the notion that fortification of snack foods will result in consumer confusion.

While recognizing explicitly that the FDA fortification policy does not establish “legally enforceable responsibilities,” the new Guidance urges food manufacturers that elect to add nutrients to a food for human consumption to follow the principles of the fortification policy, including the following guidelines:

  • Principles of “Rational Fortification.” The Guidance states that there are four primary “principles of rational fortification,” which were also part of the established 1980 fortification policy.  Those principles permit the addition of essential nutrients to food for purposes of:
    • Correcting a dietary insufficiency;
    • Restoring nutrient levels to those prior to storage, handling, and processing (the restoration principle);
    • Providing a balance of vitamins, minerals and protein in proportion to the total caloric content of the food (nutrient-to-calorie balance principle); and
    • Preventing nutrient inferiority in a food that replaces a traditional food in the diet.

The Guidance cites as an example of rational fortification the addition of calcium to a soy beverage because a soy beverage would be a reasonable vehicle for people who do not drink milk, such as those who are lactose intolerant, but wish to obtain calcium, and essential nutrient (mineral).

  • Conditions that Added Nutrient Should Satisfy.  The Guidance states that, before a nutrient is added to food, manufacturers should ensure that the nutrient is:
    • Stable in the food under customary conditions of storage, distribution, and use;
    • Physiologically available from the food.
    • Added at an “appropriate level to avoid excessive intake of that nutrient, considering cumulative amounts from all sources in the diet” (e.g., level does not exceed an existing upper intake level (UL) established by the Institute of Medicine (IOM));
    • The nutrient is “suitable for its intended purpose” and complies with FDA safety requirements (e.g., GRAS or approved food additive).
  • “Inappropriate Fortification.”  The Guidance states that “it is not appropriate to fortify certain foods, such as” fresh produce, meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.  As noted above, the Guidance also states that it is inappropriate to fortify unsweetened carbonated beverages, low-calorie and calorie-free snack foods (e.g., low calorie or fat free cookies), and alcohol beverages.
  • “Essential Nutrients.”  The Guidance states that only the addition of “essential nutrients” to food is covered by FDA’s fortification policy.  “Essential nutrient” refers to the vitamins and minerals assigned Reference Daily Intakes (RDIs), and to protein and potassium which have been assigned Daily Reference Values (DRVs).
  • “Mandatory” and “Voluntary Fortification.”  The Guidance states that FDA uses the principles in the fortification policy in issuing regulations requiring nutrients to be added to food, such as standards of identity regulations that require folic acid to be added to various enriched grain products (mandatory fortification).  In addition, the Guidance states that manufacturers “should also follow the fortification policy” described in the Guidance for “voluntary fortification” of foods, including when the following types of foods are fortified:
    • Foods that do not have a standard of identity;
    • Nutritionally modified versions of foods that have a standard of identity (e.g., orange juice with added nutrients);
    • Foods that qualify for a “healthy” claim as a result of added nutrients.
  • Excluded Foods. The Guidance states that FDA’s fortification policy does not apply to animal foods, infant formulas, or dietary supplements.
  • Enforcement.  The Guidance states that FDA’s fortification policy is primarily used as “guidance,” but has incorporated by reference the provisions of the fortification policy into the nutrient content claim regulations for two nutrient content claims: (1) “more” claims (and synonyms “fortified,” “enriched,” “added,” “extra,” and “plus”; and (2) “healthy” claims (and related claims “healthful,” and “healthier”).  If a fortified food does not comply with FDA’s fortification policy and is marketed with express or implied “more” or “healthy” claims,  the Guidance suggests that “FDA may issue a warning letter and take enforcement action.”

FDA issued the guidance as a final guidance, rather than as a draft guidance to be finalized as a letter date.  As it typically does with non-draft guidance documents, FDA is accepting written comments without a specified deadline for submission of comments.

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

Posted in Dietary Supplements, Enforcement, FDA, FTC

On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S. Postal Inspection Service, the IRS, the Department of Defense, and the U.S. Anti-Doping Agency. The event was flush with provocative statements by agency officials painting “dietary supplements” categorically as dangerous and improperly labeled and marketed. The following are just a few examples.

  • Department of Justice: “Almost every day, news sources . . . feature stories about the dangers of dietary supplements. A supplement is laced with an undeclared pharmaceutical ingredient. A study is released about adverse health effects of a so-called natural remedy. An athlete or member of the military falls ill after taking an untested energy product. These stories arise across the country all too often. Consumers turn to supplements when they want to lose weight, get an edge in athletic performance, or improve their overall well-being. From California to Maine, consumers ingest pills, powders, and liquids everyday not knowing if they do what they claim to do.”
  • Department of Defense: “Ensuring the readiness of the force is one of the Department’s top goals. Supplements are a top threat. Why do I say that?  More than 70% of active duty service members take some type of supplement. We also know that 20% of those take performance-enhancing, bodybuilding, or weight loss supplements.”
  • U.S. Postal Inspection Service: “Health can suffer if none of the advertised claims work, [and products] can even pose health risks. The U.S. Postal Service helps to halt scammers from selling their wares to unsuspecting citizens. Working with law enforcement, we hope to protect the American consumer by keeping these scams at bay through a multi-pronged approach of prevention, education, and prosecution.”

In the course of the press conference, bare assertions were made concerning allegedly violative dietary supplement products despite the lack of any fact finding or legal ruling by any court to date, and settlements were listed as legal victories for the government, even though companies routinely settle cases to forego the cost and uncertainties of litigation regardless of actual liability. Unfortunately, this questionable PR event was conducted in a manner that failed to recognize or respect the many responsible companies that make up the “dietary supplement” industry that have a strong track record for legal compliance. In addition, the PR event was a due process disappointment in its tendency to characterize named defendants as virtually certain wrongdoers. After all, the defendants are just that – defendants. The defendants have not yet “had their day in court” and may not have even had a chance to consider litigation or a settlement. Due process has had better days in Washington.

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

Posted in FDA, Foods and Beverages

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following:

  • Should FDA define the meaning of “natural” through notice and comment rulemaking?
  • Should FDA prohibit “natural” claims?
  • If FDA defines the meaning of “natural” for labeling purposes, what types of foods should be allowed to qualify as “natural”?
  • Should only raw agricultural commodities qualify as natural?
  • Should multi-ingredient foods be labeled as “natural” and, if so, what types of ingredients should be disqualified?
  • Should the term account for agricultural production practices (e.g., biotechnology, pesticides, animal husbandry practices)?
  • Is there evidence that consumers associate “natural” with “organic” claims?
  • What are the public health benefits of FDA defining the term “natural”?
  • Should “natural” have some nutritional benefit associated with the food?
  • How would FDA determine whether a food labeled as “natural” complies with any criteria for the claim?

FDA has a long-standing policy for the use of the term “natural” for human foods, providing that “natural” means that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. But this policy is only informal, and FDA has declined to adopt a formal regulation pertaining to the term “natural.”  As such, in Holk v. Snapple Beverage Corp., 575 F.3d 329 (3d Cir. 2009), the Third Circuit determined that the FDA policy did not preempt state law claims.  Since the Holk decision, other courts have ruled similarly.  There has been a deluge of consumer class action litigation involving legal challenges to “natural” claims in recent years.

FDA decided to invite public comment concerning the regulation of “natural” claims in food labeling, in part, because it received three citizen petitions, from the Grocery Manufacturers Association, Sara Lee Corp., and The Sugar Association, asking that the agency define the term “natural” for use in food labeling. FDA also received a citizen petition from the Consumers Union asking that the agency prohibit the term “natural” in food labeling.  In addition, several federal courts have requested administrative determinations from FDA regarding whether food products containing ingredients produced using biotechnology or foods containing high fructose corn syrup may be labeled as “natural” under the Federal Food, Drug and Cosmetic Act.

FDA announced that, during its review, it will work with the USDA’s Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term “natural” in meat, poultry, and egg products.

The relevant docket number is FDA-2014-N-1207. The comment period will be open for 90 days, and comments can be submitted electronically or in hard copy.

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

Posted in Drugs, FDA

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug procedures.  The stay serves to encourage scientific research into the relationship between diet and health while FDA considers numerous comments questioning the novel application of IND rules to foods, dietary supplements, and cosmetics. The stay is effective immediately.

Specifically, the FDA has stayed parts of the subsection on conventional foods (VI.D.2), and all of the subsection on studies intended to support health claims (VI.D.3), with one exception: the stay of the health claim subsection does not apply to clinical studies that include:

  • children under one year of age;
  • people with altered immune systems; or
  • people with serious or life-threatening medical conditions.

As a result of the stay, researchers and sponsors of studies to determine whether a conventional food or dietary supplement may reduce the risk of a disease and that are intended to support a new or expanded health claim do not need to obtain an IND, unless the study population includes members of these sensitive groups.  In addition, researchers and sponsors of studies of non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND while the stay is in effect.  Importantly, however, the stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  Foods and dietary supplements used for those purposes are considered drugs under FDA rules.

Historically, FDA had required Investigational New Drug Applications to be filed prior to clinical research on unapproved “new drugs” primarily to enable pharmaceutical companies to develop the scientific evidence necessary to support FDA approval and commercialization of new drug products.  But in September 2013, the Final Guidance broadly expanded the scope of studies subject to the IND requirements, targeting clinical research involving articles of food, dietary supplements, and cosmetics to IND requirements, even though those products are not “drugs” under the Food, Drug, and Cosmetic Act when they are not intended to diagnose, cure, mitigate, treat, or prevent a disease.  In response to multiple comments asking for a further opportunity to comment on subsections VI.C (relating to cosmetics) and VI.D (relating to foods), FDA reopened the comment period as to those subsections.

During the comment period, FDA received comments from trade organizations, individual companies, scientific associations, public interest organizations, and individuals discussing the effect of FDA’s expansion of the IND process.  Many of these commenters expressed concern over FDA’s statutory ability to expand the IND rules to foods, dietary supplements, and cosmetics, and also over the practical implications of imposing IND requirements on such a broad range of studies.  Commenters suggested that the new policy would discourage important health research and shift clinical research outside of the United States.  Moreover, the comments questioned whether the new restrictions were justified, considering that the products are subject to existing safety standards, have often been proven safe through years – if not centuries or millenia – of safe consumption, and generally pose less risk than unapproved new drugs.

FDA has said that, during the period of stay, it is taking time to further consider these comments.  We will continue to monitor developments on this issue.

WLF Working Paper Assesses Ninth Circuit Preemption Decision

Posted in FDA, Foods and Beverages, Litigation

In Reid v. Johnson & Johnson, the Ninth Circuit heard an appeal of one of the many state law-based consumer class actions over food labeling. A new Washington Legal Foundation Working Paper by Sarah Roller and Katie Bond assesses the Ninth Circuit’s refusal in Reid to grant preemptive effect to a 2003 FDA letter of enforcement discretion. Johnson & Johnson had made certain label claims based on the 2003 letter, in which FDA sought to expand its existing health claim on phytosterols and heart disease pending final rulemaking. The Working Paper posits that by exercising its enforcement discretion in allowing additional phytosterol claims, FDA balanced the burdens of rulemaking against First Amendment commercial speech considerations and the public health benefit of valid health information reaching consumers as expeditiously as possible. In refusing to acknowledge this important role of the FDA in the area of commercial speech, the Ninth Circuit sets a precedent that threatens a wide variety of truthful, FDA-allowed claims – not the least of which are qualified health claims which rely entirely on FDA letters of enforcement discretion. The new Working Paper reviews Reid, assesses its implications, and examines where other circuits stand on preemption and FDA letters of enforcement discretion.

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

Posted in Biologics, Drugs, FDA, FTC, Regulation

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs.  The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request for “comments on other matters related to the development and regulation of drug and biological products labeled as homeopathic.”

Under its 1988 Compliance Policy Guide (CPG), FDA permits the manufacture and distribution of OTC homeopathic products without FDA approval provided certain conditions are met including that they are “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms).”  Conversely, products offered for conditions not amenable to OTC use must be marketed as prescription products and be approved by FDA prior to being manufactured or distributed.  In encouraging FDA to reconsider this framework, FTC staff suggested that FDA’s requirement that homeopathic drugs display an indication for use “even when the product has not been demonstrated to be efficacious for that indication” is inconsistent with the FTC’s requirement that health claims be substantiated by competent and reliable scientific evidence.  FTC staff further noted that the potential conflict does not exist for other products such as dietary supplements and non-homeopathic drugs because both FTC and FDA law require substantiation to support efficacy claims for non-homeopathic products.

The comment also cites a National Advertising Division (NAD) case in which an advertiser defended its claims for a homeopathic product on the grounds that neither the FDA nor the FTC required substantiation for such claims.  Staff noted that the FTC has always required substantiation for such claims, but that “staff has been reluctant to pursue cases against OTC homeopathic products because the Commission’s traditional remedies, such as requiring that health claims be supported by competent and reliable scientific evidence, could create a potential conflict with FDA policy under the CPG.”  Staff also cited consumer research suggesting that many consumers do not understand the nature of homeopathic products, how they are regulated, or the level of substantiation required for such products as further support for FDA reevaluating its approach.

While the staff comment did not expressly advocate for a particular resolution, it noted that the current potential conflict could be resolved in three ways: (1) FDA withdrawing the CPG and subjecting homeopathic drugs to the same regulatory requirements as other drug products, (2) FDA eliminating the requirement in the CPG that an indication appear on the labeling, or (3) FDA requiring any indication appearing on the labeling to be supported by competent and reliable scientific evidence but otherwise maintaining the current regulatory approach.  While not noted in the comment, the second approach, however, would not seem to address FTC’s concerns about consumer confusion as to the efficacy and nature of homeopathic products.

The comment period for submission of comments to FDA closed on Friday, August 21.  We will continue to monitor developments related to the regulation of homeopathic products here.

“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.