FDA issues draft guidance regarding “qualified facilities” under FSMA HARPC framework.

  • In September 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA).  Under both the human food rule and the animal food rule, “qualified facilities” are subject to modified requirements.  A qualified facility is defined as:  (1) a very small business (defined with respect to annual market value of food sold or held); or (2) a facility with average annual sales of <$500,000 over the prior 3-year period and with at least 50% of sales directly to consumers or to local retailers or restaurants (within the same state or within 275 miles of facility).  21 CFR 117.3 (human food); 21 CFR 507.3 (animal food).  Under the modified requirements, a business must submit a form to FDA, attesting to its status as a qualified facility.
  • FDA has now released a draft guidance document intended to assist qualified facilities with HARPC compliance.  The draft guidance takes the form of an FAQ document and addresses how to determine whether a business meets the definition of a “qualified facility.”  The guidance also addresses when to submit the requisite attestation form to FDA, and a companion instructional document details how to obtain, complete, and submit the form (human food or animal food) to FDA.  Qualified facilities generally must submit their first attestation to FDA by December 17, 2018 (for human food) or by December 16, 2019 (for animal food).  Beginning in 2020, facilities must re-submit their attestation to FDA every two years during the food facility biennial registration renewal period (Oct 31-Dec 1).
  • The draft guidance document contains practical and detailed advice with respect to specific questions and issues that facilities may confront as they plan for HARPC compliance, e.g., how to perform the requisite accounting calculations, how to adjust for inflation, how to handle situations in which 3 years of financial records are not yet available, and how to convert foreign financial data into U.S. dollars, among others.  FDA will be accepting comments on the draft guidance until November 14, 2016.

FDA hosting three public meetings to focus on FSMA import provisions.

  • With FSMA implementation in full swing, FDA has announced that it will be hosting three one-day public meetings in different regions to focus on the import provisions of the FDA Food Safety Modernization Act (FSMA).
  • Specifically, the meetings will focus on import safety programs, (i.e. foreign supplier verification programs (FSVPs) for importers of food for humans and animals, accreditation of third-party certification bodies and FDA’s Voluntary Qualified Importer Program (VQIP)).
  • The meetings will be held on June 7; 15; and 21 in Costa Mesa, CA; Rutherford, NJ; and Detroit, MI, respectively.  Parties interested in attending are encouraged to register early, and additional details are available at this link.

FDA issues final guidance related to medical foods.

  • Medical foods are a special sub-category of foods that are “formulated to be consumed or administered enterally under the supervision of a physician.”  Further, medical foods are “intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”  21 USC 360ee(b)(3).  FDA considers the statutory definition to narrowly constrain the types of products within the medical food category.  In 2013, FDA issued a draft guidance document providing FAQs to address common questions about the definition of and regulations for medical foods.
  • FDA has now issued a final guidance document related to medical foods.  The 12-page document contains FAQs to assist stakeholders with determining whether products meet the “medical food” definition and with understanding the labeling and other FDA regulatory requirements applicable to this product category.
  • The final guidance serves as a reminder that the category of medical foods is narrowly defined.  For instance, it bears noting that FDA does not consider pregnancy or diabetes mellitus to be conditions associated with “distinctive nutritional requirements,” and thus, FDA will not view products targeted at these populations as medical foods.  Particularly because FDA has issued Warning Letters to companies marketing products that did not fit the statutory definition, industry is encouraged to exercise caution and due diligence with respect to marketing foods in this narrow space.

FDA releases most recent diet survey findings.

  • FDA conducts periodic consumer surveys by telephone to help the Agency gain a better understanding of consumer knowledge, attitudes, and practices about current and emerging nutrition and labeling issues.
  • FDA recently released the results of its 11th Health and Diet Survey, which was conducted in 2014.  Among other data, the survey revealed that:
    • 77% of adults reported reading the Nutrition Facts label “always,” most of the time,” or “sometimes” when buying a food product;
    • Nearly all persons surveyed believed Americans consume too much salt, with 50% reporting that consumers can most effectively control sodium consumption, while 25% and 5% believed more effective sodium reduction efforts should come from food manufacturers/retailers and the government, respectively;
    • Almost 9 in 10 adults reported using claims such as “low in sodium, “rich in antioxidants,” “contains no added sugar,” and “no sugar added” when buying food products.  However, only one third of adults thought these claims accurately describe the products; and
    • 90% of survey respondents had heard about trans fat in food, but a quarter of this group could not tell whether trans fat raises, lowers, or has no relationship with the risk of heart disease.
  • FDA analyzes the diet survey data in conjunction with past surveys to help guide informed regulatory, educational, and other decisions in the food arena.  Based on the nature of the survey and the trends reported, we anticipate that many other stakeholders — such as food marketers — also may glean useful insights from reviewing these data.

FDA to revisit definition of “healthy” on food labels.

  • FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving.  (Fish and meat are required to contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving).  As covered on this blog last December, FDA received a Citizen Petition requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.
  • According to media reports, FDA is planning to “reevaluate the regulations concerning nutrient content claims, generally, including the term, ‘healthy,’ in light of evolving research.”  As part of this effort, FDA reportedly plans to solicit stakeholder comments “in the near future” regarding what “healthy” should mean on food labels.
  • If FDA takes the same approach that it appears to be taking in the “natural” claim arena, then the next step will be a request for comments to help inform and initiate the formal rulemaking process.  However FDA ultimately decides to proceed, we anticipate that it will take several years at a minimum before any official change to the nutrient content claim criteria can become effective.

FDA recognizes Canada’s food safety system as comparable to U.S.

  • As previously covered on this blog, FDA has issued a final rule to implement its Foreign Supplier Verification Program (FSVP) under the FDA Food Safety Modernization Act (FSMA).  Some importers are exempt from the FSVP requirements or are subject to modified requirements, depending on specific factual circumstances.  For instance, the rule excludes from most of the standard FSVP requirements (including the hazard analysis and verification requirements) certain food from a foreign supplier in a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
  • FDA has now officially signed an arrangement with the Canadian Food Inspection Agency (CFIA) and Health Canada by which each country recognized the other’s food safety systems as comparable to each other.  Canada thus becomes only the second food safety system that FDA has recognized as comparable, following New Zealand’s recognition in 2012.  Reportedly, Australia and the European Commission are in process to achieve similar recognition.
  • The exclusion above is beneficial to importers, as it will help alleviate the FSVP compliance burden for foods being imported from recognized countries.  In order for the exclusion above to apply, the foreign supplier must be within the regulatory oversight and in compliance with the foreign country’s food safety system.  In addition, the importer must continually monitor the foreign supplier to ensure it remains in good standing with the food safety authority of the country in which the foreign supplier is located.  The general compliance date for the FSVP provisions is May 29, 2017.

FDA’s regulatory authority extended to all tobacco products.

  • As covered previously on this blog, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency deems to be subject to the law.
  • On May 5, FDA pre-published its long-awaited Deeming Regulation, which will be published in the Federal Register on May 10, and become effective 90 days thereafter, on August 8, 2016.  The new rule will extend FDA’s regulatory authority to all currently unregulated “tobacco products”, including e-vapor and e-liquid products that contain tobacco-derived nicotine, cigars, hookah, and pipe tobacco.
  • Once effective, the newly covered products will be subject to the same Tobacco Control Act requirements that currently only apply to the regulated tobacco product categories noted above.  Most significantly,  FDA chose not to amend the “grandfather date” of February 15, 2007 for deemed products, which means that to remain on the market after the effective date, such products must be:
    • the subject of a Premarket Tobacco Application (PMTA) filed within 24 months of the effective date of the rule (i.e., by August 8, 2018);
    • the subject of a Substantial Equivalence (SE) Application filed within 18 months of the effective date (i.e., by February 8, 2018); or
    • the subject of an SE Exemption Request filed within 12 months of the effective date i.e., by August 8, 2017.
  • If FDA does not grant the product marketing authorization within 12 months following the above-noted deadlines, the product must be removed from the market.
    • To support an SE claim, a manufacturer must be able to identify a “valid predicate,” which is a tobacco product commercially marketed in the U.S. as of February 15, 2007, or a tobacco product previously found SE.  As previously covered by our e-vapor regulatory practice, this requirement is particularly concerning to the vapor industry; the sophisticated products currently marketed are vastly different to the rudimentary disposable models first introduced, and in any case, FDA has been able to identify only one e-cigar product that “may possible be able to serve as a valid predicate.”  If the SE pathway is foreclosed, a manufacturer’s only option is to pursue the much more onerous PMTA pathway.
    • A potential saving grace for industry remains: the Cole-Bishop Amendment, which, if approved, would change the “grandfather date” from February 15, 2007 to August 8, 2016, the effective date of the regulation.  For in-depth coverage of this amendment and its implications, click here.
  • Among other things, the final rule also requires pre-market authorization for deemed products that are not on the market as of August 8, 2016, prohibits the sale of “covered tobacco products” to individuals under the age of 18, and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements.

Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice and will be covering the final rule, and the accompanying guidance documents, in greater detail in the near future.  To be added to the mailing list for our tobacco & e-vapor regulatory practice, click here.

For more information about our tobacco & e-vapor regulatory practice in general, click here.

FDA completes transfer of jurisdiction over catfish inspection to USDA.

  • As previously covered on this blog, FDA and the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) have been implementing a transfer of regulatory authority with respect to catfish inspection.  Moving forward, FSIS will be responsible for conducting inspections for domestically-raised and imported Siluriformes fish.
  • On May 2, FDA announced the completion of the transfer of the domestic and import inspection program for siluriformes fish and fish products to FSIS.
  • Although the industry has been divided in its reactions to the catfish inspection program, it appears that implementation is well underway and that FSIS has already begun working with firms associated with these types of fish and fish products.

 

Royal College of Physicians encourages e-cigarette use as a substitute for smoking.

  • Public health authorities worldwide have long known and publicized the health risks associated with smoking and tobacco use.  Smoking still remains the leading cause of preventable death in the United States.  As FDA prepares to publish its “Deeming Regulation” — which is expected to capture e-cigarettes and e-liquid that contain tobacco-derived nicotine as regulated tobacco products under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act — stakeholders have been concerned that the proposed “one-size-fits-all” approach to tobacco product regulation would effectively destroy the growing e-vapor industry, despite mounting evidence that these products are substantially less harmful than traditional combustible tobacco, like cigarettes.
  • In late April 2016, the Royal College of Physicians (RCP) — Britain’s professional association dedicated to setting and improving medical standards — issued a groundbreaking report lauding the benefits of e-cigarettes as safer alternatives to smoked tobacco.  The 200-page report summarizes the science, public policy, regulation, and ethical issues related to e-cigarettes and concludes that vaping is not a “gateway” to smoking.  On the contrary, “the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely.”  The report estimates that e-cigarettes are only 5% as harmful as traditional cigarettes and that long-term effects of nicotine from vaping are likely to be minimal.  The report concludes that it is in the interest of public health to “promote the use of e-cigarettes, NRT [nicotine replacement therapy] and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.”
  • The RCP report has garnered widespread media coverage and has been met with controversial reactions in the United States.  In response to the report, a spokesman for the Centers for Disease Control (CDC) reiterated the Agency’s contrary position that no conclusive scientific evidence supports the use of e-cigarettes as a safe and effective cessation tool at the population level.  Particularly because the RCP issued the original groundbreaking report on the dangers of smoking in 1962 (in advance of the American Surgeon General’s 1964 report that linked smoking to cancer), it will be virtually impossible to ignore their latest statement of policy on this subject.  It remains to be seen whether American and other global public health officials ultimately may follow suit and revise their policies with respect to the potential benefits of e-cigarette use.

Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice; for more information about this practice area in general, click here.

FDA finalizes enforcement policy with respect to therapeutic veterinary diets.

  • As a general matter, companies may not make therapeutic or “drug” claims in connection with the marketing of food or feed, including pet food.  However, in reality, therapeutic pet food products have been marketed for years without official drug approvals in accordance with FDA’s longstanding enforcement discretion policy in this space.  In 2012, FDA issued a draft Compliance Policy Guide (CPG) explaining the criteria that the Agency would consider when determining whether to take enforcement action regarding dog and cat food diets intended to treat specific diseases.  FDA generally has exercised enforcement discretion with respect to “drug requirements” for therapeutic pet food products where: (1) the product provided all or most nutrients in support of an animal’s total required daily nutrient needs; (2) labels and marketing materials made available to the general public did not contain claims to treat or prevent disease; and (3) the products were distributed only through licensed veterinarians.
  • In April 2016, FDA issued a final version of its CPG on therapeutic veterinary diets.  Consistent with the draft CPG, the final version confirms FDA’s view that although therapeutic veterinary diets technically are “drugs” under the law, the Agency is “less likely” to initiate enforcement action when 11 specific criteria are met (e.g., marketing solely through licensed veterinary channels, the manufacturer’s compliance with food regulatory requirements, and avoidance of “drug claims” directly on the product label, among others).
  • Although the CPG provides a list of regulatory and marketing conditions that may diminish the risk of FDA enforcement action within this highly specialized market, the policy provides no exceptions to the requirement that ingredients in therapeutic veterinary diets be approved food additives, generally recognized as safe (GRAS), or listed in the Official Publication of the Association of American Feed Control Officials (AAFCO Manual).  In this manner, although the CPG may provide manufacturers in this space with some flexibility related to the “drug” requirements, companies still must comply with the “food” requirements to market therapeutic veterinary diets.