FDA Tweaks Its Four Foundational FSMA Proposed Rules

By Robert Hahn

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA).  Those four rules are:

  1. Produce Safety;
  2. Preventive Controls for Human Food;
  3. Preventive Controls for Animal Food; and
  4. Foreign Supplier Verification Programs (FSVP).

Comments on the supplemental proposed rules are due December 15, 2014.

The “Supplementals” respond to many of the strongest criticisms of the proposed rules, including:

  • Criticism that the proposed rule on Preventive Controls for Human Food would cause many farms to have to comply with both that rule and the Produce Safety rule;
  • Criticism of the agricultural water standards in the Produce Safety rule as unrealistic and not scientifically based;
  • Criticism that it would be unfair to require product testing, environmental monitoring, and supplier verification in the final rules on Preventive Controls for Human Food and Preventive Controls for Animal Food without first offering specific regulatory language for public comment; and
  • Criticism that FDA access to audit reports required in the Preventive Controls for Human Food and FSVP rules would discourage free communication between third-party auditors and audited facility personnel.

FDA officials are claiming that the Supplementals would increase the flexibility of the proposed rules and reduce the burden of compliance.  While that is true for the most part, the Supplementals would also increase the burden on industry in some respects.  Some examples of that increased burden include:

  • The aforementioned addition of product testing, environmental monitoring, and supplier verification (and new recordkeeping requirements associated with those new measures) in the two preventive controls rules;
  • The added requirement that importers perform a broad risk evaluation (and associated recordkeeping) in the FSVP rule; and
  • The added requirement that the hazard analysis performed by facilities under the preventive controls rules and by importers under the FSVP rule consider the potential for economically motivated adulteration.

Another concern is the use of somewhat vague or subjective standards that will require further elucidation in guidance and inevitably leave much discretion to FDA field inspectors.  Examples of this include:

  • The two preventive controls rules would require product testing as a verification measure, when appropriate, based on the facility, the food, and the nature of the preventive control.
  • The preventive controls rules and the FSVP rule would permit use of supplier verification activities other than annual onsite audits for hazards that present a threat of serious adverse health consequences or death to humans or animals (SAHCODHA) if the facility or importer documents its determination that such other verification activities are adequate to ensure safety. Under what circumstances would such a determination be reasonable?
  • Under the preventive controls rules and the FSVP rule, facilities and importers would be required to consider economically motivated adulteration in their hazard analyses when that type of adulteration is reasonably foreseeable. Although FDA offers some discussion of when economically motivated adulteration should be considered reasonably foreseeable, there are certainly to be many instances where this is likely to be a close call.

Below we provide what we hope is a handy summary of the major changes to the four proposed rules that would be made by the Supplementals.

Produce Safety

  • Changes the scope of farms subject to the Produce Safety Rule:
    • The definition of “farm” would be expanded to include farms that engage in certain additional activities (g., packing raw agricultural commodities (RACs) grown on other farms not under the same ownership, drying/dehydrating RACs to create a distinct commodity where such drying is akin to harvesting).
    • Farms and farm mixed-type facilities with average annual sales of produce (not all food) of $25,000 or less during the previous 3-year period would be exempt.
  • Revises the water quality standard and water testing frequency:
    • Quantitative microbial quality standards consistent with the Environmental Protection Agency’s (EPA) 2012 recreational water quality criteria (RWQC) would be adopted.
    • Farms would be able to meet the new standards by alternative means (g., allowing a sufficient time interval between last irrigation and harvesting to allow for microbial die-off using a specified die-off rate, allowing a sufficient time interval between last irrigation and end of storage to allow for microbial die-off).
    • Different frequencies for water testing would be established based on the source and use of the water.
  • Revises the interval between application of biological soil amendments and harvesting:
    • The proposed 9-month interval for untreated manure would be withdrawn, to be replaced by a to-be-decided interval after FDA conducts additional research and a risk assessment.
    • The proposed 45-day interval for composted manure has been eliminated as unnecessary.
    • FDA states that it does not intend to object, for the time being, to farmers that comply with the intervals specified for organic crops in the National Organic Program regulations.
  • Clarifies that the Produce Safety Rule does not require farms to engage in “taking” of threatened or endangered species, destroy wild animal habitat, or clear borders around outdoor growing areas or drainages.
  • Establishes withdrawal and reinstatement procedures for the exemption for “qualified facilities.”

Preventive Controls for Human Food

  • Expands exemptions from preventive controls:
    • The definition of “farm” would be expanded to encompass farms that engage in certain additional activities (consistent with the Produce Safety Rule change discussed above).
    • The exemption for facilities solely engaged in the storage of RACs, other than fruits and vegetables, for further distribution or processing would be expanded to encompass storage facilities that engage in activities incidental to the storage of food (g., fumigation, blending lots of the same RAC, grading).
    • The exemption for facilities solely engaged in the storage of packaged foods that are not exposed to the environment would be expanded to include storage facilities that also engage in activities incidental to the storage of food (g., affixing tracking labels, breaking down pallets, assembling variety packs).
    • “Very small business” would be defined to mean businesses with annual sales of human food of less than $1 million.
  • Expands exclusions from current good manufacturing practice (CGMP) to include:
    • Farms (using the expanded definition of “farm” discussed above);
    • Activities of farm mixed-type facilities that fall within the definition of “farm”:
    • Holding or transportation of RACs;
    • Hulling, shelling, and drying of nuts (but not roasting, which constitutes “manufacturing/processing”); and
    • Fishing vessels that are not required to register with FDA.
  • Expands the hazard analysis requirement:
    • A covered facility’s hazard analysis would be required to consider the risk of economically motivated adulteration where there is a past history of such adulteration involving that food.
    • A covered facility’s hazard analysis would be required to consider environmental pathogens where a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize the environmental pathogen.
  • Adds supplier controls as a new preventive control:
    • Receiving facilities would be required to implement supplier control programs for raw materials and ingredients for which they have identified a significant hazard that is controlled before the raw materials or ingredients reach the receiving facility.
    • “Receiving facility” would be defined as a facility subject to preventive controls that manufactures/processes raw materials or ingredients. Therefore, facilities that only pack or hold food (g., warehouses) would not be required to have supplier controls.
    • Supplier controls would not be required if the hazard is controlled by: (a) the receiving facility; or (b) the receiving facility’s customer (provided the receiving facility annually obtains from the customer written assurance that the customer follows procedures to control the hazard).
    • To verify their suppliers, receiving facilities may choose from four options: (a) onsite audits of suppliers; (b) sampling/testing of raw materials and ingredients; (c) review of suppliers’ food safety records; and/or (d) other appropriate verification activities.
      • However, if there is a reasonable probability that the hazard in a raw material or ingredient would cause serious adverse health consequences or death to humans, the receiving facility must conduct annual onsite audits of the supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
      • Alternative verification requirements would apply to “qualified facilities” and farms that are not subject to the Produce Safety Rule.
    • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
    • The receiving facility would be required to take action to address supplier nonconformance, but FDA would not mandate any particular action.
  • Adds requirement to conduct product testing and environmental monitoring, under certain circumstances, to verify the implementation and effectiveness of a facility’s preventive controls:
    • Product testing would be required where a covered facility determines it is appropriate based on the facility, the food, and the nature of the preventive controls (which product testing would be used to verify).
    • Environmental monitoring would be required where an environmental pathogen is identified as a significant hazard in a RTE food that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.
  • Adds new recordkeeping requirements, but clarifies that existing records may be used to satisfy all recordkeeping requirements.
  • Clarifies that human food facilities that ship byproducts for use in animal food are not subject to the Preventive Controls for Animal Food Rule, unless they engage in processing of the byproducts for use in animal food (g., drying, heat treatment).
  • Establishes procedures for withdrawal and reinstatement of exemption for “qualified facilities.”

Preventive Controls for Animal Food

Note: Some of these changes (e.g., requirements for product testing and environmental monitoring, supplier controls, and addressing economically motivated adulteration) are being proposed explicitly to garner public comments and will not necessarily be included in the rules when finalized.

  • Expands exemptions from preventive controls:
    • The definition of “farm” would be expanded to encompass farms that engage in certain additional activities (consistent with the Produce Safety Rule change discussed above).
    • The exemption for facilities solely engaged in the storage of RACs, other than fruits and vegetables, for further distribution or processing would be expanded to encompass storage facilities that engage in activities incidental to the storage of food (g., fumigation, blending lots of the same RAC, grading).
    • The exemption for facilities solely engaged in the storage of packaged foods that are not exposed to the environment would be expanded to include storage facilities that also engage in activities incidental to the storage of food (g., affixing tracking labels, breaking down pallets, assembling variety packs).
    • “Very small business” would be defined to mean businesses with annual sales of animal food of less than $2.5 million.
    • Human food facilities that provide byproducts used in animal food would be exempt, unless they further process such byproducts.
  • Adds requirement that a facility’s hazard analysis to consider the potential for economically motivated adulteration.
  • Adds supplier controls as a new preventive control:
    • Receiving facilities would be required to implement supplier control programs for raw materials and ingredients for which they have identified a significant hazard that is controlled before the raw materials or ingredients reach the receiving facility.
    • “Receiving facility” would be defined as a facility subject to preventive controls that manufactures/processes raw materials or ingredients. Therefore, facilities that only pack or hold food (g., warehouses) would not be required to have supplier controls.
    • Supplier controls would not be required if the hazard is controlled by: (a) the receiving facility; or (b) the receiving facility’s customer (provided the receiving facility annually obtains from the customer written assurance that the customer follows procedures to control the hazard).
    • To verify their suppliers, receiving facilities may choose from four options: (a) onsite audits of suppliers; (b) sampling/testing of raw materials and ingredients; (c) review of suppliers’ food safety records; and/or (d) other appropriate verification activities.
      • However, if there is a reasonable probability that the hazard in a raw material or ingredient would cause serious adverse health consequences or death to animals, the receiving facility must conduct annual onsite audits of the supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
      • Alternative verification requirements would apply to “qualified facilities” and farms that are not subject to the Produce Safety Rule.
    • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
    • A receiving facility would be required to take action to address a supplier’s nonconformance, but FDA would not mandate any particular action.
  • Adds requirement to conduct product testing and environmental monitoring, under certain circumstances, to verify the implementation and effectiveness of a facility’s preventive controls:
    • Product testing would be required where a covered facility determines it is appropriate based on the facility, the animal food, and the nature of the preventive controls.
    • Environmental monitoring would be required where an environmental pathogen is identified as a significant hazard in a RTE animal food (g., dog and cat kibble) that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.
  • Makes changes to proposed animal food CGMP:
    • The requirement that ill employees be excluded from working in animal food facilities would be deleted.
    • The requirement that raw material and ingredients must be free of microorganisms harmful to human or animal health, or be treated to eliminate them, would be deleted.
    • Facilities that hold animal food would be required to store them in a manner that prevents contamination from garbage or trash, and shipping containers and bulk vehicles used to distribute animal food would be required to be inspected prior to use.
  • FDA is also requesting comment regarding whether feed mills associated with fully vertically-integrated animal farming operations should be subject to CGMP and preventive controls. FDA is considering whether to subject fully vertically-integrated farming operations to the same regulatory requirements as vertically-integrated operations that provide feed to contract farmers.

Foreign Supplier Verification Programs

  • Expands the hazard analysis requirement, adding a new “risk evaluation”:
    • The requirement that importers conduct a compliance status review of each foreign supplier and imported food would be deleted, but that requirement would be folded into the new risk evaluation.
    • A new risk evaluation requirement would be added. The risk evaluation would be required to evaluate the hazard analysis, which entity is controlling identified hazards, the foreign supplier’s food safety procedures and practices, applicable FDA food safety regulations and the foreign supplier’s compliance with those regulations, the foreign supplier’s food safety performance history, and other appropriate factors (g., storage and transportation practices, recent changes in the management of the foreign supplier).
    • The importer’s hazard analysis would be required to consider the risk of economically motivated adulteration where there is a past history of such adulteration in that type of food from that country.
    • The importer’s hazard analysis would be required to consider environmental pathogens where an environmental pathogen is a significant hazard in a RTE food that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.
  • Modifies the verification activities that importers must perform:
    • Importers generally would be able to choose from four options: (a) onsite audits of foreign suppliers; (b) sampling/testing of imported foods; (c) review of foreign suppliers’ food safety records; and/or (d) other appropriate verification activities.
      • However, if there is a reasonable probability that the hazard in an imported food would cause SAHCODHA, the importer must conduct annual onsite audits of the foreign supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
      • Alternative verification requirements would apply when the foreign supplier is a farm that is not subject to the Produce Safety Rule.
    • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
    • Verification activities would not be required if: (a) preventive controls by the importer (under the Preventive Controls for Human Food Rule) are adequate to significantly minimize or prevent all significant hazards in the imported food; or (b) preventive controls by the importer’s customer (under the Preventive Controls for Human Food Rule) are adequate to significantly minimize or prevent all significant hazards in the imported food, and the importer annually obtains from its customer written assurance that it follows procedures to control such hazards.
    • A new requirement that the importer establish and follow written procedures to ensure that it imports food only from approved foreign suppliers would be added. However, importers would be permitted to import food from unapproved foreign suppliers when necessary on a temporary basis, provided the importer conducts adequate verification activities (g., sampling and testing individual shipments) before using or distributing such food.
    • The requirement that importers maintain a list of all of their foreign suppliers would be deleted.
  • Defines “very small importer” and “very small foreign supplier” to mean an importer or foreign supplier with less than $1 million in annual sales of human food. Modified requirements apply to very small importers and imports from very small foreign suppliers.
  • Clarifies that importers that are also facilities subject to one of the preventive controls rules, and that are in compliance with the supplier control requirements of the applicable preventive controls rule, are deemed to be in compliance with FSVP Rule, except that they must still identify the importer at time of entry.

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 15, 2014, 1:00 p.m. EST

During this webinar, the second of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

  • Requirements for drug importation into the U.S. and Canada
  • Pharmaceutical market approval pathways in both countries
  • Pharmaceutical manufacturing controls in both countries
  • Pricing of brand and generic pharmaceuticals in Canada
  • Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
  • Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
  • Inspections and enforcement

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act.  She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA).  Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market.  She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions.  She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

Consumers are Misled About Organic Safety

By John R. Block, as published in the Des Moines Register

Every day millions of shoppers are paying out as much as 50 or 100 percent more to buy organic foods for themselves and their families. I have friends who make these choices because they have no reason to question claims on labels, in advertising and on social media that organic foods are safer, healthier and more nutritious.

One thing they will not read on any label is a new finding from Academics Review, a group of scientists dedicated to testing popular claims against peer-reviewed science.

The scientists’ conclusion based on U.S. Food and Drug Administration (FDA) reported recall information: Organic foods are four to eight times more likely to be recalled than conventional foods for safety issues like bacterial contamination. Nor will consumers see anywhere a reference to the body of peer-reviewed research finding that organic foods are no more nutritious than foods produced by conventional agriculture.

Why are consumers so misinformed? This is not an unimportant problem. It’s dangerous. The very people most likely to seek out organic food for its purported safety — the elderly, pregnant women, parents of young children and people with compromised immune systems — are most at risk from organic’s higher risk of contaminants, including deadly e-coli.

As Academics Review founder Bruce Chassy, a professor of food microbiology at the University of Illinois, recently reported to a professional trade association, not only is the federal government failing to require that the organic food industry state these risks to consumers. It also allows organic companies to make unfounded safety claims that, if they were made by any other industry, would attract the ire of federal regulators.

Lacking such scrutiny, the organic industry appears to have adopted “black marketing” against conventionally grown foods as its core strategy. The Natural Marketing Institute admitted as much when it reported that “the safety message is a clear driver” of organic sales. A marketing executive for a major organic company was little blunter: “You can, and perhaps should, lead with fear as an industry.”

The industry does, in fact, lead with fear. The websites, social media, product packaging, marketing materials and annual reports of organic food companies are full of fear-based advertising against conventional farming. Even more hysterical claims about conventional foods are pushed in food scare campaigns run by NGOs funded by the organic foods industry, as well as by allied natural food and health companies.

In the midst of such claims, where do consumers turn for reliable information? They trust federal regulators to give them the straight scoop based on science. Yet even here, the federal government is passively complicit in allowing unscientific claims to mislead consumers. Exhibit A in federal complicity is the U.S. Department of Agriculture (USDA) certified Organic label.

USDA’s research shows that more than 70 percent of consumers are likely to believe a food is safer, more nutritious or of higher quality if it bears the organic label. In fact, all the label signifies is that a given food has been grown, handled and processed without many of the modern techniques of conventional agriculture.

The label does not even mean that a certain food was grown without pesticides. Organic foods are routinely produced with certain kinds of “organic” pesticides. Meanwhile, organic recalls due to bacterial contamination are ballooning along with the expanding market for organic food.

In short, the federal government is strict about science, labeling and claims for all industries except one. The marketers of organic food are allowed to make scientifically false and misleading claims about the safety and wholesomeness of conventional food, while their products are increasingly likely to be recalled for safety reasons.

Federal agencies have a statutory responsibility to crack down on untruthful and misleading claims in food marketing. They also have a responsibility to warn consumers about real dangers.

The findings by Academics Review raise a number of questions federal regulators should have to answer.

– Will the USDA, FDA and Federal Trade Commission enforce existing rules against misleading advertising when marketers misuse the organic label to vilify competitors?

– Will regulators regard the sponsored attacks on conventional agriculture as advertising, subject to standards of truth?

– Will the Centers for Disease Control and the Food and Drug Administration investigate what is behind the frighteningly high recall record of organic food?

– And will the government perform more research on the safety of organic foods?

This is no longer a matter of who wins at the checkout counter. For many vulnerable people, it is a matter of safety. They just don’t know it yet.

JOHN R. BLOCK was U.S. secretary of agriculture from 1981 to 1986. The lifelong farmer now is senior policy adviser to the law firm of Olsson Frank Weeda Terman Matz PC in Washington, D.C. Contact: jblock@ofwlaw.com.

What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations

Don’t sit back and wait: Be proactive!

By Bruce Silverglade

The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed.  The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new serving sizes for foods.  This is a big deal because the nutrient content information that appears on the “Nutrition Facts” label must be listed for customarily consumed amounts determined by FDA.  So, new serving sizes will effectively dictate the amount of each nutrient for particular foods that will appear on the label.  Similarly, the Agency has proposed to redefine what a single serving package is, and to require that calories, fat, sodium, sugars and other nutrient amounts be listed for the entire package on the assumption that it will be consumed on a single eating occasion.  In brief, larger serving sizes mean labels will list larger amounts of nutrients that some consumers may wish to avoid.

Hundreds of companies and trade associations have filed comments with the Agency; some believe that filing is the end of the public participation process.  Nothing could be further from the truth. Filing a comment with FDA is the first, not the last, step in participating in the development of a final regulation.

The comments that have been filed are being analyzed by Agency staffers and summaries will be given to senior FDA policy makers in the Commissioner’s office.  Under the Administrative Procedure Act, FDA is required to review and respond to the comments and provide a “reasoned explanation,” in a preamble to any final regulation, explaining why the Agency agrees or disagrees with the views that have been expressed.

That may sum up the textbook description of the rulemaking process but, in reality, numerous other factors will influence FDA’s final regulations.  Concerned stakeholders should consider the following additional actions:

  • Review the comment record:  The comments already submitted to FDA on key provisions of the proposed regulations can provide a treasure trove of information.  By reviewing the comment record, interested parties can discern who may share their viewpoint, who is opposing, and why.  In some cases, stakeholders may be surprised at what they find.
  • Meet with FDA officials:  Agency officials will sometimes agree to meet and sometimes will not.  But the importance of face-to-face discussions with Agency decision makers cannot be overemphasized.  As in any business development situation, meeting personally with those in charge can be infinitely more valuable than communicating in writing.  Unlike business situations, FDA officials will place a short memorandum on the public record indicating that a meeting took place, but that legal requirement should not deter stakeholders from making efforts to reach out to the Agency.
  • Contact the White House Office of Information and Regulatory Affairs (OIRA):  OIRA is a department within the White House Office of Management and Budget.  OIRA plays a major role in reviewing regulations proposed by FDA and other agencies by conducting rigorous economic and public policy analyses before permitting proposed regulations to be finalized.  Contrary to conventional wisdom, OIRA has assumed a particularly strong role under the Obama Administration.  OIRA officials may agree to meet with stakeholders.  Meetings may be difficult to obtain, but should remain a key objective of concerned parties because OIRA, not FDA, may make the final determination about what the Agency’s rules actually require.
  • Urge OIRA to require FDA to follow proper procedures: OIRA signed off on a portion of FDA’s proposal requiring “added sugar” content to be disclosed on the “Nutrition Facts” label (total “sugars” are already required to be disclosed), but inexplicably failed to approve a research study the Agency wanted to conduct to determine how consumers would react to the new disclosure before the proposed regulation was published in the Federal Register.  OIRA finally approved the research planned by the Agency after the proposed rule was published, but clearly FDA should not proceed any further with its proposed rulemaking until the results are in, put out for public comment, and analyzed.  Despite the delay, OIRA retains authority to compel FDA to follow that sensible approach.
  • Meet with key Members of Congress: To maximize the chances of seeing final FDA regulations that comport with the recommendations in a company’s written comment, stakeholders should meet with key Members of Congress (or their senior staffers) to inform Hill offices about the issues at stake, the tentative position of the FDA, and your company’s concerns.  It is particularly effective to request meetings with Members of the House and Senate Committees that have jurisdiction over FDA’s annual appropriations, as well as leading Members from Congressional committees that have FDA oversight responsibilities. These Members of Congress have a particular interest in seeing that the Agency is on the right course and making decisions on the basis of sound public policy.  Ultimately, concerned parties may request that Members of Congress write the FDA, hold oversight hearings, or consider restrictions in FDA’s annual appropriations bill that require the Agency to act in a particular manner.

These advocacy measures are well known within the Washington Beltway, but are often overlooked by stakeholders who believe there is little they can do to affect FDA policy once a written comment is submitted.  Parties wishing to maximize their chances of achieving changes in FDA’s proposed rules before they are finalized should consider availing themselves of these additional steps that can, and almost certainly will, affect the final regulatory requirements they will have to comply with in the not so distant future.

Risk Communication about Methylmercury in Seafood

By Michael J. O’Flaherty

FDA has announced that its Risk Communication Advisory Committee (RCAC) will be holding a public meeting on November 3-4, 2014, at its White Oak Campus in Silver Spring, MD.  The RCAC meeting will focus on messages about the importance of eating adequate amounts of fish and shellfish, while avoiding certain varieties with higher amounts of methylmercury.  Such messages are especially important for women who are pregnant or nursing, and for anyone who prepares food for young children.  Methylmercury is a neurotoxin that can be harmful to the brain and nervous system if a person is exposed to too much of it.

Fish and shellfish are an important part of a healthy diet.  Fish and shellfish contain high-quality protein and other essential nutrients; are low in saturated fat; and contain omega-3 fatty acids.  A well-balanced diet that includes a variety of fish and shellfish can contribute to heart health and children’s proper growth and development. This being the case, women and young children (in particular) should include fish and shellfish in their diets due to the many nutritional benefits.

However, nearly all fish and shellfish contain traces of methylmercury.  For most people, the risk from methylmercury by eating fish and shellfish is not a health concern. However, some fish and shellfish contain higher levels of methylmercury that may harm an unborn baby or young child’s developing nervous system.  The risks from methylmercury in fish and shellfish depend on the amount of fish and shellfish eaten and the levels of methylmercury in these fish and shellfish.

In June 2014, FDA and EPA jointly issued a draft update to their 2004 advice regarding fish and shellfish consumption.  The draft advice essentially encourages pregnant women, those who may become pregnant, breastfeeding mothers, and young children to eat more fish and shellfish, and to select a variety from choices that are lower in methylmercury.  This updated draft advice is consistent with recommendations made in the 2010 Dietary Guidelines for Americans, and is based on a risk assessment that was peer reviewed.

The updated draft advice recommends that pregnant women eat at least 8 ounces (oz) and up to 12 oz (2-3 servings) per week of a variety of fish that are lower in methylmercury to support fetal growth and development.  It cautions pregnant or breastfeeding women to avoid four types of fish that are associated with high methylmercury levels, i.e., tilefish from the Gulf of Mexico, shark, swordfish, and king mackerel.  In addition, it recommends limiting consumption of white (albacore) tuna to 6 oz per week.  Choices lower in methylmercury include some of the most commonly eaten fish, including shrimp, pollock, salmon, canned light tuna, tilapia, catfish, and cod.

The RCAC public meeting is part of FDA/EPA’s efforts to finalize the updated draft advice.  Before issuing final advice, the agencies intend to consider public comments and the advice of FDA’s RCAC, and to conduct a series of focus groups.  Comments on the updated draft advice may be submitted to the FDA docket or by participating in the public meeting.

The RCAC public meeting’s topic, of course, reasonably is relevant to the prospective labeling and advertising interests of fish and shellfish purveyors.

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 29, 2014, 1:00 p.m. EST

During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others:

  • A general understanding of the regulatory framework for foods and beverages, including the distinction between foods and natural health products in Canada
  • Agencies responsible for regulating foods and beverages
  • Requirements for food and beverage imports
  • A general introduction to labeling and promotional requirements and restrictions
  • Enforcement and food safety compliance including an overview of the status of the U.S. Food Safety and Modernization Act and the Safe Food for Canadians Act, and managing a food recall.

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please go to http://www.cvent.com/d/14qf66.

About the presenters:

Bob Hahn is a principal at Olsson Frank Weeda Terman Matz PC in Washington, DC. He advises companies and trade associations on compliance with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration (FDA) regulatory requirements for foods and beverages, including product formulation, food safety, food defense, food labeling and advertising, import/export of food, and handling of inspections, recalls, and enforcement actions. Bob’s clients include all levels of the food production and distribution chain, including manufacturers, processors, packers, distributors, and retailers, as well as industry trade associations. He regularly speaks and writes on FDA food regulatory matters.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is head of the firm’s Food and Beverage Group. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of, among others, the food and beverage industry. Sara works with clients to get products from idea to market, providing strategic advice on approval and marketing strategies. She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls. Sara is a regular contributor to a number of food and beverage industry publications and conferences and is an active blogger on food safety and other regulatory matters (www.thefoodlawyer.ca).

FDA Food Facility Registrations Must Be Renewed Soon

By Michael J. O’Flaherty

It is October 1st and time to renew your food facility registration(s) with FDA.

Facilities (domestic and foreign) engaged in manufacturing, processing, packing, or holding food (human or animal) for consumption in the United States must register with FDA, unless exempt.  Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 350d) requires food facilities that are required to register with FDA to renew their registrations every two years, during the period beginning on October 1 and ending on December 31 of each even-numbered year.  Failure to comply with the registration requirement, including biennial renewal, is a prohibited act, subject to injunction and criminal prosecution.

This being an even-numbered year, you are required to renew your facility registrations starting today, and FDA is encouraging food facilities to renew early in the three-month renewal period.

As you may recall, in 2012, some facilities that did not renew their registrations in a timely manner found that FDA had invalidated their registrations and needed to obtain new registrations and new registration numbers.  In addition, some foreign facilities that did not renew their registrations had their shipments stopped at the port.  To avoid those headaches, we suggest renewing your FDA registrations while the subject is fresh in your mind.

While you’re at it, be sure to update any registration information that may have changed.  You are required to update any required registration information (e.g., the name, address, and phone number of the owner, operator, or agent in charge of the facility; an emergency contact phone number) within 60 calendar days after a change in that information.  You may also want to consider requesting proof of registration renewal from your suppliers.

To renew a registration of a food facility during the applicable time period, go to Registration of Food Facilities.  For additional information about facility registration, see:

•    Registration under FSMA;
•    Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide (Dec. 2012);
•    Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) (Dec. 2012)
•    Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (Oct. 2012); and
•    FDA Issues Final Compliance Policy Guide on Food Facility Registration (June 2014).

How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 1, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics will include, among others:

  • Device classification schemes in the U.S. and Canada
  • Marketing authorization mechanisms in Canada and the U.S.
  • Manufacturing controls in both countries
  • Canadian and U.S. labeling and promotional requirements and restrictions
  • Reporting of adverse events in both countries
  • Recordkeeping and reporting requirements imposed by both countries

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Neil O’Flaherty is a principal at OFW Law, a Washington, D.C.-based law firm, where he has been practicing as a member of the firm’s Medical Device Practice Group for more than 23 years. Neil advises clients from around the world on a wide range of matters relating to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices. Of particular relevance, Neil assists clients with labeling and promotional issues, the development of strategies to bring medical devices to market, pre-submission advocacy, adverse event reporting compliance and other postmarket requirements, and preparation of necessary regulatory filings.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by Canada’s Food and Drugs Act, its related regulations, and their intersection with intellectual property issues. She advocates before all branches of Health Canada on behalf of the medical device, pharmaceutical, biotech, food and beverage, natural health product, and cosmetic industries. Sara works with clients to get products from idea to market while providing advice on approval and marketing strategies.

Hatch-Waxman Turns 30 – A Stroll Down Memory Lane

By Arthur Y. Tsien

Happy Birthday, Hatch-Waxman!  You’re a mature 30-year old now, a regular adult.  Some personal musings on my stroll down the Hatch-Waxman Memory Lane over the past 30-plus years follow.

A small background digression:  For those of you in the FDA regulatory arena who are real newbies or who have been in a Rip Van Winkleoid state in recent times, the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (formally known as the Drug Price Competition and Patent Term Restoration Act of 1984) are the statutory basis for generic drug products sold in the United States today.  FDA can approve a generic drug based on an “abbreviated application” that demonstrates that the generic product is equivalent to the brand or innovator drug product being copied, without repetition of laboratory animal safety studies and human clinical trials that support the approval of the brand drug.  Before Hatch-Waxman, FDA would consider an abbreviated application only for a copy of a brand drug product first approved before 1962.  As a result, very few “generic” versions of most newer brand name prescription drugs were available.

I was working in FDA’s Office of Chief Counsel as a young attorney during the latter part of Hatch-Waxman’s long gestation period.  Although not designated a “drugs” attorney, I was quite familiar with the pre-Hatch-Waxman regulatory landscape by virtue of having worked on several court cases involving “generic” drugs.  This included United States v. Generix Drug Corporation, 460 U.S. 453 (1983), where the Supreme Court in essence upheld FDA’s policy that each “generic” copy of a brand drug had to be approved in its own drug application, rather than being able to take advantage of “old” drug status based on “general recognition” of the active ingredient’s safety and effectiveness.

I joined OFW Law not long after Hatch-Waxman became law.  Our first generic drug client of any consequence appeared soon thereafter.  It was a true shoestring startup operation with perhaps 50 employees, financed by credit card cash advances and operating out of a set of very modest, adjacent buildings of a type typically associated with, say, independent car repair shops.

Despite its limitations and seemingly tenuous hold on life, our erstwhile client had remarkable success in getting its generic drug applications reviewed and approved by FDA very quickly.  It all seemed too good to be true, and it was.  Subsequent FDA investigation revealed that our client (and others of similar mindset) had given items of substantial value to key FDA staff to have their applications reviewed out of sequence.  Some less-than-honorable firms also submitted fraudulent data to FDA in their applications, helping ensure approval in the first review cycle.

Suffice to say, both such practices are highly disfavored under federal criminal and regulatory law.  These activities, often called the “generic drug scandal” of the late 1980s and early 1990s, were a sad chapter in the histories of both the generic drug industry and FDA.  Hatch-Waxman, let’s just attribute that to the growing-up process during your early years.

In the days before the 1995 Oklahoma City Federal Building bombing and 9/11, the Parklawn Building, FDA’s then-headquarters in Rockville, Maryland, was wide open to all members of the public, just like most other federal buildings.  It was a common practice for pharmaceutical company (whether brand, generic, human, or animal) regulatory affairs personnel to make periodic visits to FDA, roaming the halls and visiting with reviewers of their firm’s applications.  In that climate, it was relatively easy for unscrupulous company personnel to surreptitiously offer unlawful things of value (like a wad of cash sticking out of a drug application that a company rep was personally delivering to an FDA staffer).  The old days of open federal buildings are gone forever, needless to say.

As FDA’s investigation of our former client unfolded, FDA summarily “rescinded” its recent approval of one of our client’s drug applications.  Patently illegal, I thought, because FDA has to follow the statutory procedure for withdrawing approval.  So, we sued FDA over its purported rescission.  We lost, soundly.  See American Therapeutics, Inc. v. Sullivan, 755 F. Supp. 1 (D.D.C. 1990).  That experience gave personal meaning to the often-heard lawyers’ adage, “bad facts make bad law.”  It was also my first (and last) experience with moving for judgment on the pleadings, a procedure resurrected from my inactive memory of first year law school civil procedure class.  Never again!

In response to the “scandal,” debarment, civil penalty, and additional withdrawal of approval provisions were added to the FDC Act in 1993.  In its wisdom, Congress decided that, for the most part, these additional provisions would apply only to abbreviated applications for generic drugs, not to full drug applications for brand drug products.

Following the “scandal,” a number of waves of administrative and judicial activity regarding the approval of generic drug products washed ashore during Hatch-Waxman’s teenage and young adulthood years.  In the 1990s, most activity centered on the substantive conditions of FDA approval, such as whether the generic product and its brand counterpart have the “same” active ingredient, dosage form, or labeling or whether the generic is bioequivalent to its brand counterpart.  Hatch-Waxman provides for 180-day exclusivity, under which the first generic drug applicant to challenge a patent on the brand product being copied gets a statutory 180-day “head start” over its generic competition.  Until 1998, 180-day exclusivity was very seldom rewarded.  In that year, however, the D.C. Circuit rejected FDA’s former “successful defense” regulation, under which a “first” generic applicant had to have prevailed in patent litigation to be eligible for 180-day exclusivity.  See Mova Pharmaceutical Corp. v. Shalala, 162 F.3d 1201 (D.C. Cir. 1998).  Post-Mova, a 180-day exclusivity period was likely to be associated with generic versions of every brand drug product for which there was an associated patent challenge.  Thus, after Mova opened the flood gates, the generic drug regulatory world was awash with 180-day exclusivity disputes and litigation during much of the first decade of this century.  Congress made fundamental changes to 180-day exclusivity in the Medicare Modernization Act of 2003, but that only led to more disputes and litigation.

I am pleased and honored to have represented a number of different clients in these administrative and judicial battles that helped shaped the current regulatory landscape for generic drugs, although I wish my win-loss record were better.

Today, the generic drug industry has grown and matured from its humble beginnings.  For example, the five largest suppliers of generic drugs in the United States (by prescription volume, according to the internet) – Teva, Mylan, Actavis (nee Watson), Sandoz, and Lupin – are all global, publicly traded companies with tens of thousands of employees.  Generic drugs account for the substantial majority of all prescriptions filled, but only a much smaller portion of total prescription drug spending.  Annual U.S. savings from generic prescription drugs are many billions of dollars.

Hatch-Waxman also provides countervailing benefits for brand drug companies, such as non-patent data exclusivity and patent term restoration to compensate for patent life lost during product development and FDA review.  Nothing indicates to me that brand drug companies have suffered as a result of Hatch-Waxman.

The current frontier for “generic” pharmaceutical competition is drug products of biological, rather than synthetic chemical, origin.  The Biologics Price Competition and Innovation Act, modeled loosely on Hatch-Waxman in many respects, became federal law in 2010 and created a regulatory pathway for FDA approval of “biosimilars.”  The top two selling prescription drugs in the world are AbbVie’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab), both of which are very expensive drugs indicated for the treatment of Crohn’s Disease, arthritis, and similar conditions.  A biosimilar version of Remicade has been approved in Europe, and biosimilar versions of Humira appear to be the subject of substantial effort by a number of companies.  According to public reports, the first biosimilar applications were submitted to FDA last month, including one for a biosimilar version of Remicade.  Scientific, medical, and legal arguments in opposition to the approval of specific biosimilars have been raised in the U.S., similar to arguments that were raised in opposition to the approval of generic drugs under Hatch-Waxman.  Perhaps the first biosimilar will be approved in the U.S. soon.  If so, only time will tell whether it will gain widespread marketplace and prescriber acceptance.  Stay tuned as history unfolds!  Hatch-Waxman, we will be watching to see if your progeny does at least as well as you have as it grows up.

Hatch-Waxman, it’s been a good 30 years.  May the next 30 be even better.

Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

By Michael J. O’Flaherty

The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated foods that contain an egg product(s) as an ingredient because USDA’s Agricultural Marketing Service (AMS) now provides this service.

FDA regulates the safe production, sanitary processing, and labeling of food products containing egg products.  Nevertheless, since it assumed responsibility for conducting the federal egg products inspection program from AMS on May 28, 1995, FSIS has been issuing export certificates of wholesomeness for prepared or manufactured food products that contain egg products as an ingredient.

On April 3, 2013, AMS announced the establishment of the Processed Egg and Egg Products Export Program.  The AMS program pertains to FDA-regulated, further processed eggs and egg products and composite foods containing egg products.  Pursuant to a Letter of Agreement between USDA’s Foreign Agricultural Service and the Office of International Affairs at FDA, AMS was provided with the authority to perform onsite verification of public health certification statements and issue export certificates on a fee for service basis.  The extent of the onsite verification process is directly related to the complexity of the certification statements required by the foreign country of destination for the food product.

Establishment of the export certification program is intended to allow U.S. processors access to expanding global markets, supporting AMS’ goal of promoting the marketing of U.S. agricultural products.  Companies interested in requesting the service should file an application with AMS.  Once the application is submitted, AMS will determine the import requirements of the foreign authority(s) for the food product(s) identified in the application.  AMS has established a program for verification of the source of the eggs and egg products used in the production of the food products identified for certification.  Additionally, AMS will verify that the product was produced in a processing facility in accordance with good manufacturing practices under sanitary conditions to certify that the products are fit for human consumption, as well as that the product meets the foreign government import requirements.  The verification of a product will require a minimum of two onsite visits per year.  If AMS determines that a company meets the established certification requirements, the company will be listed as eligible for export by product and country.  An eligible company then may contact AMS for an export certificate covering an accepted product(s) and identifying the foreign country.

Prior to shipping certified food products, exporters should have their importers confirm that the foreign country will accept AMS’ certification statements.  Additional packaging and labeling requirements also may need to be addressed with the importer before the food product will be allowed into the foreign country.

If you are an exporter of a FDA-regulated food that contains an egg product as an ingredient and need an export certificate(s), you should engage the AMS soon.  Please feel free to come to us with any questions related to AMS’ new verification and export certification program.