Supreme Court Holds FD&C Act Does Not Bar Competitor Food Label Challenges under the Lanham Act

By Michael J. O’Flaherty and Stewart D. Fried

In a recent opinion delivered by Justice Kennedy (with Justice Breyer recused), the U.S. Supreme Court unanimously held that competitors may bring Lanham Act claims challenging food labels, even if such labels technically comply with regulations promulgated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  This essentially means that the FD&C Act and its regulations are not a ceiling on the regulation of food labeling because Congress intended the Lanham Act and the FD&C Act to complement each other with respect to labeling.  While this ruling substantially affects how food labeling compliance should be analyzed prospectively from a Lanham Act/potential competitor lawsuit perspective, it does not necessarily impact directly how such compliance must be analyzed from a State consumer protection/class action lawsuit perspective, especially inasmuch as FD&C Act § 403A makes federal standards for certain food label information nationally uniform (i.e., preemptive of challenges alleging another standard applicable).

In POM Wonderful LLC v. Coca-Cola Co., No. 12-761 (argued April 21, 2014; decided June 12, 2014) [573 U. S. ___ (2014)],  POM Wonderful (POM), which markets a pomegranate-blueberry juice blend, filed a Lanham Act lawsuit against the Coca-Cola Company (Coca-Cola), alleging that the name, label, marketing, and advertising of one of Coca-Cola’s juice blends mislead consumers into believing the product consists predominantly of pomegranate and blueberry juice, when it actually consists predominantly of less expensive apple and grape juices.  POM sells a juice product labeled “Pomegranate Blueberry 100% Juice,” which consists entirely of pomegranate and blueberry juices.  Coca-Cola (under its Minute Maid brand) sells “Pomegranate Blueberry Flavored Blend of 5 Juices,” which contains about 99% apple and grape juices, with pomegranate, blueberry, and raspberry juices accounting for only the remaining amount.  The label on the Minute Maid product features a picture of all five fruits and the words “Pomegranate Blueberry” in a larger font than the words “Flavored Blend of 5 Juices.”  Importantly, the Minute Maid label technically complied with the labeling rules provided in the FD&C Act and in FDA’s related regulations for naming a flavored juice blend, 21 C.F.R. § 102.33.

The Court of Appeals for the Ninth Circuit affirmed the decision of the federal district court judge from the Central District of California ,which essentially had held that, in the realm of food labeling, a Lanham Act claim like POM’s is precluded by the FD&C Act.  679 F. 3d 1170 (9th Cir. 2012).  The Supreme Court reversed the Ninth Circuit decision and remanded the case for further proceedings.

The Lanham Act permits one competitor to sue another for unfair competition arising from false or misleading product descriptions.  The FD&C Act prohibits the misbranding of food marketed in interstate commerce.  To implement the FD&C Act’s provisions, FDA has promulgated regulations regarding food labeling, including one concerning the common or usual name for juice blends.  Unlike the Lanham Act, which relies (in large part) for its enforcement on private lawsuits brought by injured competitors, the FD&C Act and its implementing regulations give the federal government nearly exclusive enforcement authority and do not permit private enforcement lawsuits.  The FD&C Act also preempts certain state misbranding laws.

Lanham Act Claims Are Not Preempted by the FD&C Act

The Supreme Court held that, under this statutory structure, competitors may bring Lanham Act claims, like POM’s, challenging food labels regulated under the FD&C Act.  The Supreme Court based its holding on two premises.  First, it found that the case did not concern preemption, but rather concerned an alleged preclusion of a cause of action under one federal statute (i.e., the Lanham Act) by the provisions of another federal statute (i.e., the FD&C Act).  Second, it found that the case entailed statutory interpretation, with analysis of the statutory text, aided by established interpretive rules, controlling.  It rejected Coca-Cola’s proposition that the best way to reconcile or harmonize the statutes was to bar POM’s Lanham Act claim.

The Supreme Court also noted that these statutes have co-existed for over 70 years and that neither expressly forbids nor otherwise limits Lanham Act claims that challenge labels that are regulated under the FD&C Act.  The Court determined the absence of such a textual provision was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means” of ensuring proper food labeling.  Rejecting Coca-Cola’s argument, it concluded that Congress, by taking care to preempt only some state laws, indicated it did not intend the FD&C Act to preclude requirements arising from other sources.

The Supreme Court characterized the Lanham Act and FD&C Act as complementary in scope and purpose.  It noted that both statutes address food labeling, but the Lanham Act protects commercial interests against unfair competition, while the FD&C Act protects public health and safety.  It also pointed out that the statutes complement each other with respect to remedies — the FD&C Act’s enforcement is largely committed to the FDA, while the Lanham Act empowers private parties to sue competitors to protect their interests on a case-by-case basis – and that allowing Lanham Act suits takes advantage of synergies among multiple methods of regulation.

The Supreme Court also reasoned that if it concluded the FD&C Act precluded Lanham Act claims challenging food labels, doing so could lead to a result that Congress did not intend because the FDA does not necessarily pursue enforcement measures regarding all objectionable labels.  This being the case, preclusion of Lanham Act claims could leave commercial interests — and indirectly the public at large — with less effective protection in the food labeling realm.

The Supreme Court sharply rejected Coca-Cola’s argument that Lanham Act claim preclusion is proper because Congress intended national uniformity in food labeling, and is reasonably  instructive of how federal courts are likely to treat Lanham Act claims against food companies in the future.  First, it is now clear that Congress did not intend to foreclose private enforcement of other federal statutes when it delegated enforcement authority to the federal government pursuant to the FD&C Act.  Second, the Court removed any doubt that the FD&C Act’s express preemption provision applies only to state, not federal, law.  Lastly, the FD&C Act and its implementing regulations may address food labeling with more specificity than the Lanham Act, but this specificity matters only if the two statutes could not be implemented in full at the same time.  The Court determined that neither the statutory structures nor the empirical evidence of which it was aware indicated there would be any difficulty in fully enforcing each statute concurrently according to its terms.

Finally, the Supreme Court rejected the Solicitor General’s middle-ground position that would have precluded Lanham Act claims only to the extent that the FD&C Act or FDA’s regulations specifically require or permit particular language on a food label.  Stated differently, had the Supreme Court agreed with this argument, POM’s challenge to the name of the Minute Maid product, which complied with FDA regulations, would have been precluded but its other challenges would not have been barred.  Instead, all eight Justices found that government’s position to be fatally flawed because it assumed that the FD&C Act and its regulations established a ceiling on the regulation of food labeling, when Congress intended the Lanham Act and the FD&C Act to complement each other.

Food (and dietary supplement purveyors should keep the POM Wonderful decision in mind prospectively when assessing the enforcement risks attending labeling representations.  While the door to Lanham Act claims in food labeling disputes has been blasted open by the Supreme Court’s decision, it remains far from clear whether a plethora of state court consumer protection actions will ensue, especially given the clear statement in the opinion confirming the clear applicability of the FD&C Act’s preemption provisions to state court labeling lawsuits.  However, the creativity of the plaintiffs’ bar cannot be underestimated and, as a result, the utility of the decision in class action lawsuits challenging food labeling claims should surface reasonably soon.

The Next Dietary Guidelines Debate

By Marshall L. Matz and Nathaniel B. Fretz, as published by Agri-Pulse

There is a new question surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The question is whether the Dietary Guidelines Advisory Committee should continue to focus their review and recommendations on scientific advances in nutrition and diet or should they venture into issues surrounding “sustainability” and all that this term has come to include.

The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) have jointly published the Dietary Guidelines for Americans every 5 years since 1980. In 1990, the Congress mandated the publication in Section 301 of the National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. 5341), requiring that the report “shall contain nutritional and dietary information and guidelines for the general public….”

Beginning with the 1985 edition, HHS and USDA have appointed a Dietary Guidelines Advisory Committee (DGAC) consisting of nationally recognized experts in the field of nutrition and health. The Committee reviews the latest scientific and medical literature and prepares a report for the Secretaries that provide recommendations for the next edition of the Dietary Guidelines based on the preponderance of the scientific evidence available.

This time, as HHS and USDA prepare for the 2015 Dietary Guidelines, the DGAC has created a new subcommittee on “Food Sustainability and Safety.” The HHS Office of Disease Prevention and Health Promotion has the administrative leadership for the 2015 edition and is supported by USDA’s Center for Nutrition Policy and Promotion. Leadership on the Dietary Guidelines alternates between HHS and USDA each five years. The Departments then jointly review the Advisory Committee’s recommendations and develop and publish the revised Dietary Guidelines for Americans policy document.

Where this new dimension goes…considering “Food Sustainability and Safety” as a part of the Dietary Guidelines…remains to be seen. It is a significant departure from dietary advice based on the science of nutrition and health. Up to this point, the Dietary Guidelines has been confined to micro-nutrient and macro-nutrient recommendations. As there is no legal definition to the term “sustainable” it could go in a number of directions.

Congress has taken notice. The House Appropriations Committee addressed this development with the following report language that accompanied the FY 2015 Agriculture Appropriations Bill:

“Dietary Guidelines.—The Committee is concerned that the advisory committee for the 2015 Dietary Guidelines for Americans is considering issues outside of the nutritional focus of the panel. Specifically, the advisory committee is showing an interest in incorporating sustainability, climate change, and other environmental factors and production practices into their criteria for establishing the next dietary recommendations, which is clearly outside of the scope of the panel. The Committee directs the Secretary to ensure that the advisory committee focuses only on nutrient and dietary recommendations based upon sound nutrition science and not pursue an environmental agenda. Should environmental or production factors be included in the panel’s recommendations to USDA and the Department of Health and Human Services, the Committee expects the Secretary to reject their inclusion in the final 2015 Dietary Guidelines for Americans.”

The Dietary Guidelines for Americans was based on the 1977 publication, Dietary Goals for the United States, released by the Senate Select Committee on Nutrition. In releasing the Dietary Goals, Chairman George McGovern emphasized they were dietary recommendations intended to reduce diet as a risk factor in the etiology of disease and promote nutritional health. McGovern said at the time: “We must acknowledge and recognize that the public in confused about what to eat to maximize health. If we as Government want to reduce health costs and maximize the quality of life for all Americans, we have an obligation to provide practical guides to the individual consumer as well as set national dietary goals for the country as a whole.”

The Dietary Goals were the first comprehensive statement by any branch of the Federal Government on dietary recommendations. They were not intended then, and the Dietary Guidelines are not intended now, to address agriculture production procedures or environmental issues. The issues associated with animal welfare, organic criteria, biotechnology, advertising to children or taxes are clearly beyond the scope of the Dietary Guidelines and should be discussed in a different forum.

In 2010, when the current edition of the Dietary Guidelines was released, Secretary Vilsack and Secretary Sebelius said:“We are pleased to present the Dietary Guidelines for Americans, 2010. Based on the most recent scientific evidence review, this document provides information and advice for choosing a healthy eating pattern—namely, one that focuses on nutrient-dense foods and beverages, and that contributes to achieving and maintaining a healthy weight.”

The 2015 Subcommittee on Sustainability is chaired by Miriam Nelson, Ph.D., Professor, Friedman School of Nutrition Science and Policy, Boston, MA.

The Subcommittee has two consultants. Dr. Timothy S. Griffin, Ph.D., is the Director, Agriculture Food and Environment Program; Friedman School of Nutrition Science and Policy; Tufts University; Boston, MA.

Dr. Griffin is a faculty co-director for the Tufts Institute for the Environment and is an associate professor at the Friedman School of Nutrition Science and Policy. His research expertise and interests include the intersection of agriculture and the environment, and the development and implementation of sustainable production systems.

The other consultant to the Subcommittee on Sustainability is Michael W. Hamm, Ph.D. Dr. Hamm is the Mott Professor of Sustainable Agriculture; Departments of Community Sustainability, Food Science and Human Nutrition, and Plant, Soil and Microbial Sciences; Michigan State University (MSU); East Lansing, Michigan.
At MSU he is director of the Center for Regional Food Systems which bolsters MSU’s teaching, research, and outreach around regional, community-based food systems within Michigan and around the world. His current research efforts center on the intersection of environmental sustainability, human health, and economic development in regional food systems.

Doctors Hamm and Griffin have impressive resumes and are clearly experts on the intersection between agriculture and the environment and environmental sustainability, but they are not experts on human nutrition. Dietary advice is complicated enough. The DGAC, HHS and USDA should heed the advice of Congress and stick to “dietary recommendations based upon sound nutrition science and not pursue an environmental agenda.” There are other opportunities to discuss how much room pigs and chickens should have or whether genetic modification is safe and should be labeled.

Marshall Matz and Nathan Fretz are former Senate and House Agriculture Committee Counsel now at OFW Law. Matz was also General Counsel to the Senate Select Committee on Nutrition.

Political Science or Sound Science – Is the White House Dictating Nutrition Labeling Reform? 3

By Richard L. Frank and Bruce Silverglade

The White House’s role with USDA’s regulations for school foods and the WIC feeding program has been widely reported.  Lesser known is the White House involvement in FDA food labeling policy.

To commemorate the anniversary of the Let’s Move! campaign, the first lady hosted a week-long series of events in March, one of which included announcing new proposed FDA regulations requiring the “Nutrition Facts” label on food packages to list “Added Sugars.”

The Nutrition Facts label, required since 1994, has had an uneven impact on Americans’ dietary habits.  It needs to be reformed.  For example, FDA is proposing to require the “Calories” per serving line to appear in larger, more conspicuous type for consumers to easily see.

But the White House seems to be pushing FDA to require more, including the disclosure of “Added Sugars,” which may not be necessary or even beneficial.  The FDA itself concedes:

  • “U.S. consensus reports have determined that inadequate evidence exists to support the direct contribution of added sugars to obesity or heart disease … [1]
  • The 2010 Dietary Guidelines states that “added sugars do not contribute to weight gain more than [any other] calorie source;” [2]
  • It “is not aware of any existing consumer research that has examined this topic,” [3]   i.e.  no research has ever been conducted on how consumers would interpret an “Added Sugars” disclosure on the Nutrition Facts Panel …or how it might confuse consumers.
  • “There are currently no analytical methods that are able to distinguish between naturally occurring sugars and those sugars added to a food”[4] (thus necessitating a  proposed massive recordkeeping requirement that companies keep track of the amount of sugars they use in food products).

This unprecedented mandate by FDA strays beyond the agency’s traditional legal authority and subjects food companies to additional costs that are ultimately passed on to consumers.

About a year ago, FDA requested permission from the White House Office of Management and Budget (OMB) to conduct a study to find out if an “Added Sugars” disclosure would be helpful or confusing to consumers.  However, to coincide with the anniversary of the Let’s Move! campaign, FDA, on March 3, published its proposed rule including “Added Sugars” labeling despite the absence of any consumer survey research. OMB approval of FDA’s research study was granted in an untimely fashion three weeks after the proposed regulation was published (and then only after trade press reports had drawn attention to the matter).

The consumer research study is just now underway and the results are not known … much less published for public comment.

Politically, Let’s Move! and the White House accomplished their mission.  The FDA announcement on “Added Sugars” labeling filled the national news for days even though the agency had not conducted its research project to determine if the disclosure would be helpful to consumers.

What will be the impact on the consumer?  No one really knows. Under the proposed regulation, the “Added Sugars” disclosure would be listed in a triple-indent format under the existing line for “Sugars,” which itself is indented under the line for “Total Carbohydrates.”

Even lawyers wince at triple indents in legal documents; how will a busy consumer comprehend the information when glancing at a food label in the grocery store?  Will this be another misguided attempt by the administration and only confuse consumers more?  Will it provide any long-term benefits to Americans’ health?

Why not keep it simple and just require calories to be disclosed in a more conspicuous manner? While not a perfect solution, since all calories are not the same, it would still represent an improvement in the label.

For added sugars content, the U.S. Dietary Guidelines directs consumers to check ingredient lists where sugars, along with other ingredients, are already disclosed in order of predominance.  Moreover, the amount of “Sugars” per serving is already required to be listed on the “Nutrition Facts” label under the disclosure for “Total Carbohydrates.”

Common sense says less is better…but in this case, it seems the White House and FDA are pursuing a political agenda against sugar.

Given the Let’s Move! agenda, it’s not surprising that FDA “put the cart before the horse” and proposed “Added Sugars” disclosures without completing long planned research that the White House (OMB) itself delayed.

But, basing regulatory proposals on political science, not sound science, is a recipe for policy failure.  The President himself signed an Executive Order 13563 on January 18, 2011 on Improving Regulation and Regulatory Review which stated, “It must be based on the best available science.”  Seems the White House and/or FDA are speaking out of both sides of their mouth.

The White House should direct FDA to live up to the Administration’s purported commitment to evidence-based science and regulatory policy, and withdraw the proposed “Added Sugars” labeling regulation.


[1] 79 Federal Register 11904 (March 3, 2014).

[2] 79 Federal Register 11904 (March 3, 2014).

[3] 78 Federal Register 32394 (May 30, 2013).

[4] 79 Federal Register 11905 (March 3, 2014).

Ms. Gloom Wants to Know: Does Your Product Hold Program Really “Hold” When Needed?

By Jolyda O. Swaim

Anyone who has been involved in the quality assurance and food safety side of the food business for any length of time knows that one of the top items on the list of those that will keep you awake at night is whether or not your product “hold” or retention program will be effective in preventing the shipment of product when needed.  Product can be held for a number of reasons and many of the reasons can be the trigger for a recall if for some reason the product is shipped.  I had it happen to me at several different companies for several different reasons.  Unless the product is physically “locked up” and you have the only key, you need to ensure you have as many hurdles as possible in place to: (1) account for all product on hold, and (2) make it as difficult as possible to “accidently” ship the product.

It is also important that the correct product is on hold – but that topic will be discussed in a separate blog.

Reasons Why Product May Be Held

Companies have hold or retention programs to retain products for a number of reasons.  Product may be retained – usually by the QA department – for quality reasons that don’t affect the safety of the product, but don’t meet the customers’ or your specifications.  If this product is “accidently” shipped, you may have unhappy customers or consumers but there is no food safety risk and the product does not violate any regulatory requirement.  However, your customer’s brand or your brand could suffer if this happens too many times.

Products held for regulatory violations or food safety reasons are the ones which will get you in trouble if your hold program is treated as an afterthought – especially when the warehouse or distribution center is looking at filling orders.  Product might be held because its labeling is wrong; for example, it doesn’t declare an allergen.  Other reasons include that you or a government agency tested the product or a food contact surface for a pathogen such as Listeria monocytogenes or Salmonella. In fact, when FSIS takes a sample, it is a regulatory requirement that you hold the product until the results are obtained.

If you are a FSIS-inspected establishment, you might also have product on hold because the FSIS inspector has placed a retain tag on the product.  In these situations – whether or not the product is held for a food safety reason – violation of the FSIS retain tag brings on another whole set of problems for you of which a recall maybe the smallest!

What Makes a Robust Hold Program? 

Accurate Inventory

A robust hold program needs a number of hurdles to allow you to sleep at night when there is product you absolutely do not want to leave your control.  Regardless of whether the hold is for quality or food safety reasons, all should begin with an accurate inventory of the amount of product being placed “on hold.”  If this is a hold to control product that a FSIS inspector has also tagged, make sure the product is inventoried with the inspector and you both agree on the amount.

It is important to have a written document or computer-generated form where the product details are recorded.  This should include the product name, product code, date of hold, reason for the hold, the person placing the product on hold, and quantity.  When product is released, the disposition and the number of cases released should be recorded.  If cases are pulled from the hold for testing or any other reason, these also need to be noted.

Contain the Product

Many times the effectiveness of the hold can be determined by the amount of product you need to hold.  For example, if you have several cases of product or maybe even several pallets, you may have a retain cage where these can be placed under lock and key – with you holding the key.  But there are few areas that are large enough to hold a day’s production or more under a physical lock and key.  One way to hold the a large amount of product is to load it on a refrigerated trailer, lock the door, chain the trailer to an unmovable object, and keep all keys! I know at least one General Manager who did this to ensure she could sleep at night and know that no product would “accidently” disappear.   However, there have been a few isolated cases where entire trucks have been stolen so this should also be a consideration!

If the product is being held for food safety reasons and the product cannot be held under lock and key, have it inventoried daily to ensure it is all there.  Document this check.  Many companies with computerized inventory systems have the ability to “lock-out” any hold product from being visible by the warehouse personnel that are filling orders.  This is one good hurdle, but it is important that the product actually be “locked out” in the system or it might still get shipped.  Keep in mind that the product is still physically visible, so make sure you also have visible hold tags on it.

Companies should also ensure that the physical product has hold cards visible to fork truck drivers.  Use large, bright tags, and also bright hold tape such as that used for crime scenes, to tape off the racks.  And if the hold tag is not on the side of the pallet that the driver can see, it does no good; place visible tags on each side of the pallet to prevent the excuse that “didn’t see the tag.”  And again, inventory the product daily to be sure none of it has walked away.

If you are holding product at a public warehouse, you must work with the warehouse to ensure it has a robust hold program.  Make sure that your personnel controlling the product at that location understand the need to ensure the program works.  It is always preferable to keep the hold product at your location where you have control.

Follow the Program

Companies should also make sure that any product on hold is properly released with the hold tags removed and disposition documented.  If no one in the QA department takes the time to remove the tags and you allow just anyone to do so, you have just diluted the effectiveness of your program.  If no one documents disposition and release of product, you have also diluted the effectiveness of your program.

You should also mandate that the product hold inventory is reconciled regularly.  Hold people accountable for violations of the program.  Of course, this can only be done after you provide appropriate training on the program to everyone.  Hold tags, both QA and FSIS, must be respected if you have any chance of ensuring that when product must absolutely remain under your control; that it will.  Remember that Murphy’s Law is always working against you and if product is easy to ship when on hold, it will happen!

About “Ms. Gloom”

In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew.  In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician.  In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends.  Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.

Reopening of Comment Period on Reportable Food Registry ANPR

By Michael J. O’Flaherty

The Food and Drug Administration (FDA) has reopened the comment period for an additional sixty (60) days on its advance notice of proposed rulemaking (ANPR), entitled “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.”  79 Fed. Reg. 34,668 (June 18, 2014); see also 79 Fed. Reg. 16,698 (Mar. 26, 2014) (the ANPR).  FDA is reopening the comment period based on a request for an extension to allow interested persons additional time to submit comments.

The RFR is an electronic portal for industry to use to submit reports to FDA regarding reportable foods.  A “reportable food” is an article of food (other than a dietary supplement or infant formula) for which there is a reasonable probability that use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.  A “responsible party” is a person who submitted the registration for the food facility where the article of food was manufactured, processed, packed, or held.

Section 211 of FSMA amended section 417 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 350f, to require notification of consumers who may have purchased a reportable food.  The ANPR made clear that FDA intends to implement the consumer notification requirement for reportable foods through rulemaking.

The ANPR essentially requested comments, data, and information regarding how to implement FSMA § 211.  FDA invited comments on a number of issues, including the following:

  • What information should be required in consumer notifications so that consumers can determine whether a food in their possession is a reportable food;
  • The format in which the information should be presented;
  • What types of retail establishments FDA should consider to be “grocery stores” subject to the consumer notification requirements;
  • How grocery stores should be made aware that the information has been published on FDA’s website;
  • What manners and locations are used by grocery stores to provide food recall information to consumers;
  • What constitutes prominent display or sharing of the information by a grocery store with its customers;
  • The impact on grocery stores from posting the information;
  • Whether consumers should be notified that this type of information will not be generated for dietary supplements, infant formula, and fruits and vegetables that are raw agricultural commodities; and
  • Whether FDA should require industry to submit consumer-oriented information to FDA, even if the food will not be available for sale to consumers at the retail level.

The comment period on the ANPR will now close on August 18, 2014.

“Eat Your Fish,” Say FDA and EPA

By Robert A. Hahn

The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have released draft updated advice on seafood consumption, Fish: What Pregnant Women and Parents Should Know.  The two agencies also published a Federal Register notice creating a docket and requesting public comments on their new fish consumption advice.

The draft updated advice is intended to replace a 2004 document that was seen as discouraging fish consumption by pregnant women.  Many women have avoided eating fish during pregnancy because of concerns about methyl mercury.  However, new science shows that the benefits of fish consumption outweigh the risks, and avoiding fish during pregnancy and childhood means missing out on nutrients important to growth and development.  The draft update also brings FDA and EPA recommendations in line with the 2010 Dietary Guidelines for Americans, as well as other consensus documents on seafood consumption.

The draft update accentuates the positive, emphasizing the benefits of fish consumption and recommending a minimum (not just a maximum) level of consumption.  Its advice is directed primarily to women who are pregnant (or may become pregnant), women who are breastfeeding, and young children, because the nutritional benefits of fish are particularly important for growth and development before birth, in early infancy (for breastfed infants), and in childhood.  However, the agencies state that fish consumption has health benefits for everyone, and therefore the advice should also be followed by the general public.

The key message is to “Eat 8 to 12 ounces of a variety of fish each week from choices that are lower in mercury.”  The word “fish” is used to refer to both finfish and shellfish.  The draft updated advice recommends the following actions:

  1. Eat 8-12 ounces of a variety of fish per week.

This amount represents 2-3 servings of fish per week.  This is far more than most pregnant women currently eat; one survey found mean fish consumption among pregnant women was only 1.8 ounces per week.

Children should also have 2-3 servings of fish per week, but the amount consumed should be reduced to reflect their lower calorie needs: 3-5 ounces for children ages 2 to 8; 4-6 ounces for children ages 6 to 8; and gradually increasing the amount for children over 8 years of age.

  1. Choose fish lower in mercury.

Fish lower in mercury include many common species, such as salmon, shrimp, Pollock, tuna (light canned), tilapia, catfish, and cod.

  1. Avoid the following 4 types of fish: Tilefish from the Gulf of Mexico (not Atlantic tilefish); Shark; Swordfish; and King Mackerel.  In addition, limit white (albacore) tuna to 6 ounces per week.
  1. When eating fish caught from streams, rivers, and lakes, pay attention to fish advisories on those bodies of water.

If such advice is not available for a particular body of water, adults should limit fish from that body of water to 6 ounces per week, and young children should limit consumption to 1-3 ounces per week; both adults and children should then not eat other fish that week.  EPA’s website provides historical data on local fish advisories, but suggests consulting state websites for the most current advisories.

  1. When adding more fish to your diet, be sure to stay within your calorie needs.

FDA and EPA have also released Q&As explaining the draft advice and including a table with the amounts of mercury and omega-3 fatty acids in common species of fish.

FDA and EPA are requesting comments on the draft updated advice and on alternative risk communication approaches for conveying its message.  In addition, the agencies seek comments on the following specific questions:

  • Whether two additional species, orange roughy and marlin, should be added to the list of species of fish to avoid because of methyl mercury.  Orange roughy and marlin have mercury levels that are lower than the four species to avoid listed above, but higher than nearly all other commercial fish.  In addition, they are low in omega-3 fatty acids;
  • Whether the final advice should track the language of the 2010 Dietary Guidelines more or less closely than the draft;
  • Any new science relevant to the draft updated advice;
  • Information upon which to base advice on young children’s fish consumption;
  • Suggestions for improving the clarity and utility of the advice; and
  • How to integrate local advisories about fish from local streams, rivers, and lakes.

FDA and EPA intend to seek the input of FDA’s Advisory Committee on Risk Communication and may hold public meetings on the draft updated advice.  The comment period will close 30 days after the last transcript from these meetings becomes available.

Crop Insurance Appropriations – A Clue for the next SRA?

By Kenneth D. Ackerman

The great battle for the 2014 Farm Bill is thankfully over, but that hasn’t stopped the U.S. Congress from continuing to tinker with Federal Crop Insurance.

Most recently, in late May, the House and Senate Appropriations Committees each voted to report their versions of bills to fund USDA in fiscal 2015, and each took the occasion to insert language telling USDA’s Risk Management Agency (RMA) and Federal Crop Insurance Corporation (FCIC) how to run crop insurance.  The full House and Senate will vote on the measures in the next few days.

Click here at watch the entire House markup.

But while mostly routine, one piece of report language raised eyebrows because it evoked the magic word “SRA,” the Standard Reinsurance Agreement between RMA and its participating private insurance companies, crop insurance’s highly sensitive financial backbone.

Money-wise, there were few fireworks:

  • The House Committee proposed $77,094,000 to fund RMA operations in 2015, a nice increase over the $71,496,000 level for fiscal 2014 and a nod to RMA’s expanded role under the new Farm Bill.  The Senate likewise proposed an RMA increase, to $76,779,000.
  • For FCIC itself, each side approved the traditional “such sums as are necessary,” a nod to the unpredictability of annual insurance indemnities based on weather and other uncontrollable forces, estimated at about $8.6 billion.

Pet Projects

Likewise, most of the Committee report language also was routine.  It included usual pitches by Congressmen and Senators for favorite pet projects:

  • The House urged RMA to expand its quarantine coverage for California avocado and citrus growers to other states and crops.
  • The Senate, for its part, pressed RMA to fund studies on the feasibility of covering business interruption from integrator bankruptcy and catastrophic losses to poultry, not to mention quicker adoption of special prices for organic crops.

The SRA Hint

It was the House, though, that went further and broached the SRA, saying this:

“The Committee is aware of concerns that the Standard Reinsurance Agreement (SRA) currently in effect has caused disparate treatment of crop insurance agents depending on the crop(s) they service and expects that as the Department begins the process of renegotiating the SRA it will address this inequality.

The Committee’s specific point involved technical limits on agent compensation that in some circumstances appear to favor established row crops over specialty crops – a problem that can be fixed only with a new SRA.  But the implication went deeper.

The last SRA renegotiation between RMA and its participating companies, in 2010, was unusual.  RMA managed to win some $6 billion in payment reductions to companies over a five-year period, with $4 billion going directly to “deficit reduction” – a big win for taxpayers.  Congress praised this result at the time, but found it troubling.  RMA had conducted its negotiation by itself and left Congress out of the cost-cutting process.  As a result, House and Senate Agriculture Committees (and thus the overall farm community) had no chance to tap the SRA savings for other farm or agriculture priorities.

As a result, in the 2014 Farm Bill, Congress inserted language to prevent this outcome from happening again.  Supporters called it a “budget neutrality” provision.  (See Farm Bill section 11012).  It said that, in future SRA renegotiations, RMA must keep its projected payments to companies — underwriting gains and expense reimbursements — level, no ups or downs, with any unavoidable savings going automatically to RMA programs, not deficit reduction.

This raised some questions.  SRA negotiations over the past two decades have become increasing unruly affairs: complicated, time consuming, highly political and unpredictable.

  • With budget savings off the table, why bother?
  • Or, by taking cost off the table and limiting discussion to more technocratic issues, might “budget neutrality” actually take the sting out of SRA talks, make them more tame, less contentious, and more controllable?
  • Or, going farther, might it tempt one side or the other to try to side-step the limitation by hiding sweeteners or cuts amid the SRA’s complex payment formulae?

RMA and its participating companies have many reasons to want revisions in the SRA short of big picture budget issues.  New Farm Bill programs like SCO and STAX are likely to shift risk profiles in the program and raise novel implementation issues.  A next renegotiation has been widely expected next year.

Now, Congress too seems to be arguing in favor of a new SRA.  As the “to-do” list of SRA corrections grows longer, the likelihood of a near-term renegotiation, with all the associated unknowns, grows stronger.

For the full texts of the House and Senate Appropriations reports see:

Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

By Tish Eggleston Pahl and Roger R. Szemraj

The House and Senate Appropriations Committees with oversight of FDA have been very busy.

Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports.  Roger Szemraj and the rest of our government relations practice have scoured the draft bills and reports looking for insight into what FDA drug-related activities are vexing Congress.

The Basics

On May 29, by a vote of 31-18, the full House Appropriations Committee voted out a draft version of the FY 2015 Appropriations Bill for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (the House Bill) and an accompanying draft House Report.  On May 22, by a vote of 30-0, the full Senate Appropriations Committee approved S. 2389, the FY 2015 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (the Senate Bill) and issued its Senate Report.

The President’s budget sought $2,575,383,000 for FDA.  In the House Bill, FDA receives an appropriation of $2,574,080,000; an increase of $22,175,000 over the amount provided in FY 2014, though still $1,303,000 below the budget request.  The Senate was slightly more generous, appropriating $2,588,536,000; an increase of $36,631,000 over the amount provided in FY 2014, and $13,153,000 above the budget request.

Although the Bills and Reports address myriad issues, including agricultural and conservation programs, rural development, and domestic food and nutrition programs (and we refer you back to our public policy professionals if you are interested in those issues), we’re focused here on what the House and Senate Bills and Reports have to say about FDA’s regulatory agenda for drugs.

House Bill and Report

Generic Drug Labeling Proposed Rule Targeted

The Committee was “deeply concerned” about the generic drug labeling proposed rule.  As the Committee presented the issue, the proposed rule would “change longstanding policy and allow generics to alter their label without FDA’s prior approval.”  The proposed rule has proven to be controversial with many comments filed in objection.  See, e.g., Comments by Generic Pharmaceutical Association (GPhA) and National Conference of State Legislatures; compare Comment by Public Citizen.

The House Appropriations Committee bluntly stated in its report that it “is unaware of evidence of a need to change existing regulations.”  Going further, the Committee stated that the generic drug labeling proposed rule “has the potential to threaten public health by creating unprecedented patient and provider confusion by having multiple labels for the same product, therefore undermining the longstanding policy of sameness.”

The Committee also challenged the FDA’s cost estimates for implementation of the proposed rule.  Contrary to FDA’s assertions of modest cost to implement the rule, others estimated the rule’s implementation costs to be in the billions.  The Committee believes that “sufficient evidence is lacking on how FDA derived such a low cost estimate for this proposed rule.”  The House Committee “directs the agency to complete a new economic analysis of the rule, paying particular attention to the cost of pharmaceutical products, before FDA finalizes the rule and report back to the Committee on Appropriations of both Houses of Congress within 90 days of enactment of this Act.”

Other Items of Interest in the House Report

The House Appropriations Committee was also concerned about the following additional FDA drug matters:

  • ANDA Review Prioritization – Within 45 days of enactment, the Committee directs FDA to report how it has prioritized its ANDA review process to expedite the review of Paragraph IV applications and ensure first generics are approved on the earliest possible date.
  • FDA User Fee Collections/Obligations – The Committee continues to be concerned about the financial management of FDA’s User Fee programs. The Committee directs the submission of period reports on user fees collected for each user fee program included in the Act.
  • Imports – The Secretary, in consultation with Homeland Security and Customs and Border Protection, should consider reprioritizing existing funding to ensure sufficient FDA personnel are available to clear shipments expeditiously and should develop a Trusted Trader Program to allow shipments from highly compliant importers to be released with minimal documentation or additional information being provided.
  • Pharmacy Compounding – The Committee provides an increase of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA).  The Committee urges FDA to complete inspections of compounding facilities and take all necessary enforcement actions needed to promote the safety of the drug supply chain.

Senate Bill and Report

There was nothing in the Senate Bill or Report on the generic drug labeling rule.  The Senate Appropriations Committee did, nevertheless, express its own concerns about certain drug-related matters:

  • Abuse-Deterrent Drug Development – The Committee urged FDA to make faster progress regarding abuse-deterrent opioids and directed FDA to finalize the January 2013 draft guidance on evaluation and labeling of abuse-deterrent opioids.   FDA should also publish draft guidance on the assessment of generic versions of such products and address whether human abuse liability studies will be needed.
  • Pharmacy Compounding – Like the House, the Senate Appropriations Committee focused upon FDA’s implementation of the DQSA.  The Committee directed FDA to meet with stakeholders to ensure continued access to safe compounded drugs for which there is a clinical need.
  • Counterfeit Products – The Committee recommendation includes an increase of $4,820,000 to provide FDA with additional resources to investigate counterfeit drugs.
  • Import Shipments – Like the House Appropriations Committee, the Senate Appropriations Committee encouraged FDA to improve import clearance procedures and develop a Trusted Trader-type of program.
  • Keeping Prescription Drug Inserts In Paper Format – FDA has long sought to develop ways that drug manufacturers could move providing paper-based full product labeling (known as the PI) to electronic labeling.   Entering into the fray, the Committee directed FDA to ensure that any proposed regulation preserves the paper PI.

So what’s next?

Our public policy specialists anticipate that the House will take up the Bill next week, with both chambers likely to act within the next two weeks.  From there, the Bills will move to a conference to iron out the differences, possibly in July.

As to the Report language we discussed above, typically the conference of the House and Senate will adopt all report items unless otherwise contradicted.  It will, therefore, be especially interesting to see whether the final product retains the harsh condemnation of the generic drug labeling rule, and the order that FDA undertake a new economic analysis.

Pontifications by Dr. Doom

By Barbara J. Masters, D.V.M.

As described by Dennis Johnson in his recent article from our Regulatory Round-Up Newsletter, the current human illness rate for E. coli O157:H7 has not gone down as documented by the Centers for Disease Control and is, in fact, trending upwards. This is very concerning.  Our firm has been advocating that the beef industry be aware of this information, review their food safety systems and ensure they are doing everything possible to “attack this pathogen at the slaughter and processing levels.”  As a prior regulator and a current advisor to the beef industry, I feel very strongly that this is necessary and that the beef industry has and will continue to remain vigilant in the “war on this pathogen.”

For a moment however, I must speak as a consumer, which I am.  As I search the internet, I compare downloadable menus to the FDA Food Code.  Yes, I realize the Food Code is not mandatory, and the one in use varies by state.  That said, at the “local burger joints,” this is what I have been finding:

According to the various editions of the Food Code, my burger should be cooked well done (e.g. the FDA 2013 Food Code indicates comminuted meat should be cooked to 158°F).  The Food Code does permit “consumer advisories” alerting the person ordering “of the significantly increased risk of consuming such foods by way of a disclosure and reminder such as on the menu or brochures that consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness.”  Restaurants are not permitted to serve undercooked burgers to children.

While many of the internet menus that I have found for “local burger joints” do contain the necessary advisory statement, I am left to ponder whether the consumer is more intrigued and motivated by the highlighted ordering options than they are concerned by the advisory in fine print.  “Select your protein and cooking temperature” seem to be a very popular way of presenting burgers at the current time.  The selection for rare and medium rare cooking temperatures are not discouraged, and in fact, at some locations are “suggested” as preferred.

I am very concerned that individuals ordering may be relying on the restaurant to assist them in making “safe” ordering decisions rather than on the “fine print” advisory at the bottom of the menu alerting them that eating raw or undercooked meat may cause illnesses.  It seems possible that the association between rare and undercooked has been lost. In reading “yelp” reviews of these restaurants, it is clear that the individuals eating at these locations are enjoying burgers cooked to the rare temperatures; no one is focusing on the consumer advisory.

As for me, I will continue to “advise” the beef industry to do all they can to prevent E. coli O157:H7 contamination.  I will make certain my family orders their burgers well done; as well as educate all those I can to do the same!

About “Dr. Doom”

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.  Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.

Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations.  She was the lead of the FSIS HACCP Hotline.  In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation.  She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities.  She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.

FDA Issues Final Compliance Policy Guide on Food Facility Registration

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG) on food facility registration.  Compliance Policy Guide Sec. 100.250; Food Facility Registration – Human and Animal Food.  The CPG provides guidance to FDA staff on enforcement of the requirement to register food facilities.  Comments may be submitted at any time.

All domestic and foreign food facilities that manufacture, process, pack, or hold human or animal food intended for consumption in the United States are required to register with FDA, unless a specific exemption applies.  Federal Food, Drug, and Cosmetic Act Section 415 (21 U.S.C. § 350d); 21 C.F.R. Part 1, subpart H.  The Food Safety Modernization Act (FSMA) made several changes to the registration requirement, including the following:

  • It requires certain additional information to be included in the registration form;
  • It requires covered facilities to renew their registrations every two years, between October 1 and December 31 of each even-numbered year; and
  • If FDA determines there is a reasonable probability that food manufactured, processed, packed, or held at the facility will cause serious adverse health consequences or death to humans or animals, FDA may suspend the registration of any facility that: (a) created, caused, or was otherwise responsible for the reasonable probability; or (b) knew or had reason to know of such reasonable probability but packed, received, or held the suspect food.

Failure to register a facility that is required to do so, or introducing food from such a facility into interstate commerce, is a “prohibited act,” subject to injunction and criminal prosecution.  If a foreign facility fails to register as required or its registration is suspended, food from the foreign facility must be held at the port of entry until the foreign facility is registered.  If a facility’s registration is suspended, then introducing food from that facility into interstate commerce is a prohibited act.  However, failure to register or suspension of registration does not cause food from the facility to become adulterated or misbranded.

According to the CPG, FDA may consider a facility to not be registered if:

  • The facility has not submitted a registration to FDA;
  • The facility’s registration is incomplete; or
  • The facility’s registration has expired, because the facility failed to renew it as required.  (The CPG states that FDA may notify the registrant if its facility registration has expired.)

During routine facility inspections, FDA investigators are instructed to determine whether the inspected facility is registered and whether its registration information is accurate and current.  If not, the investigator should advise the facility’s management of the requirement to register and update mandatory information on the registration form.  FDA may issue an untitled letter if the facility is not registered and the establishment file documents that facility management has been advised orally or in writing of its obligation to register.  In the case of a foreign facility, the Division of Food Defense Targeting will be notified in order to target future shipments of imported food from that facility.

FDA may suspend a facility’s registration if there is evidence that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and the facility is responsible for the problem or the facility knew or had reason to know of the problem and packed, received, or held the food.  Examples of circumstances where FDA staff should consider recommending suspension include, but are not limited to, the following:

  • Inspectional or other evidence (e.g., a Class I recall situation, food associated with foodborne illness) indicates that the firm has significant violations and has not permanently corrected the source of the problem;
  • The firm is subject to a prehearing order to cease distribution and provide notice under FDA’s mandatory recall authority;
  • The firm is subject to an emergency permit order, or the District Office is considering a recommendation to issue an emergency permit order, under 21 C.F.R. Part 108 (for low acid canned foods and acidified foods); or
  • The firm is a foreign facility, and food from the firm is subject to an Import Alert that provides for detention without physical examination because the food may cause serious adverse health consequences.

In the case of a foreign facility whose registration is suspended, the Division of Food Defense Targeting will be notified in order to target future shipments of imported food from that facility.

Registration of food facilities, which began as an administrative formality, is now a condition for doing business.