FDA Restricts Nutrient Content Claims for Omega-3s

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a final rule restricting the nutrient content claims that may be made for omega-3 fatty acids.  Specifically, FDA is prohibiting existing nutrient content claims for the two omega-3s found in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and is restricting nutrient content claims for alpha-linolenic acid (ALA), the omega-3 found in flaxseed, nuts, and certain other plant foods.

FDA has authorized several nutrient content claims for EPA, DHA, and ALA.  These nutrient content claims were authorized under a special provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 403(r)(2)(G) (21 U.S.C. § 343(r)(2)(G)).  Because this provision was added by the Food and Drug Administration Modernization Act of 1997 (FDAMA), such claims are sometimes referred to as “FDAMA claims.”  A listing of FDA’s FDAMA nutrient content claims and health claims can be found here.

Under that provision, any person may submit a notification to FDA that it intends to make a nutrient content claim based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or human nutrition research or the National Academy of Sciences.  If the notification is submitted at least 120 days before introduction of the product bearing the claim into interstate commerce, the claim is authorized and may be made unless: (a) FDA informs the notifier during the 120-day period that required information is missing from its notification; (b) FDA issues a regulation prohibiting or modifying the claim; (c) FDA issues a regulation finding that the statutory requirements have not been satisfied; or (d) a federal district court determines the statutory requirements have not been satisfied.  FDA refers to this as an “alternative, expedited notification process to allow certain nutrient content claims to be made without going through the petition process.”

FDA received three separate notifications in 2004 and 2005 for nutrient content claims about EPA, DHA, and ALA.  All three were based on authoritative statements made in a report of the Institute of Medicine, Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids.  When FDA did not object, the nutrient content claims set forth in these notifications were authorized and have been used in labeling for a variety of food products.

Today’s final rule is the first time that FDA has issued a regulation prohibiting a FDAMA nutrient content claim or health claim.  It therefore offers insight into how FDA views such claims.

First, FDA says that the authoritative statement that serves as the basis for a FDAMA nutrient content claim must identify a “single, precise nutrient level” that could serve as the basis for a Daily Value for use in nutrition labeling.  Under FD&C Act Section 403(r)(2)(G)(i), a FDAMA nutrient content claim must be based on an authoritative statement “which identifies the nutrient level to which the claim refers.”  According to FDA, the term “nutrient level” in the statute refers to a reference value “that reflects a recommended or defined intake level that could serve as the basis for setting a DV” for use in nutrition labeling.  Because the authoritative statements relied on by the notifications for the EPA and DHA nutrient content claims did not identify a precise level of EPA or DHA,  they do not satisfy this statutory requirement and cannot be the basis for nutrient content claims about EPA and DHA.  FDA also notes that the authoritative statements relied on do not appear to be authoritative statements at all, because they do not “appear explicitly as findings, conclusions, or recommendations” and therefore do not meet the National Research Council Governing Board’s definition of “authoritative statement.”

Second, FDA states that the single nutrient level that serves as the basis for a FDAMA nutrient content claim must be determined using the same approach FDA has used to determine Daily Values (DVs) for other nutrients, i.e., the “population-coverage approach.”  Under the population-coverage approach, the reference value for a nutrient is set at a level sufficient to cover all gender and age groups.  Because some of the nutrient content claims authorized for ALA (i.e., those based on a Daily Value of 1.3 g) used a “population-weighted approach,” those claims are prohibited.  According to FDA, using two different approaches to set a reference value for the same nutrient would result in inconsistent and conflicting nutrient content claims on foods, which would confuse consumers and make meaningful product-to-product comparisons impossible.

Although the agency is prohibiting nutrient content claims about EPA and DHA, food manufacturers may continue to make the following labeling claims about EPA and DHA omega-3 fatty acids:

  • The qualified health claim authorized by FDA about EPA and DHA and reduced risk of heart disease.  That claim reads:

“Supportive but not conclusive research shows that consumption of
EPA and DHA omega-3 fatty acids may reduce the risk of CHD.  One
serving of [name of food] provides __ gram(s) of EPA and DHA
omega-3 fatty acids.  [See nutrition information for total fat, saturated
fat, and cholesterol content].”

The criteria a food must meet to be eligible for this claim can be found here.

  • A permissible structure/function claim about EPA and/or DHA (e.g., “EPA and DHA omega-3s help maintain a healthy circulatory system”).
  • A factual statement about the amount or percentage of EPA and/or DHA (or of omega-3 fatty acids generally) in the food, provided such statement is truthful and not misleading and does not in any way implicitly characterize the level of EPA or DHA in the food (e.g., “Contains __ mg of EPA and DHA omega-3s per serving,” “__ mg of omega-3s”).
  • For dietary supplements, a simple percentage claim (e.g., “40% EPA and DHA omega-3 fatty acids”) or comparative percentage claim (e.g., “four times the EPA and DHA omega-3s per capsule (80 mg) as in 100 mg of menhaden oil (20 mg)”).

FDA also notes that interested persons are free to submit petitions for nutrient content claims for EPA and DHA if they believe the scientific evidence warrants them.

As a result of the final rule, only the following nutrient content claims about ALA will be permitted:


FDA says it is expressing no opinion as to whether the above ALA nutrient content claims are supported by an authoritative statement that meets the statutory requirements.

The final rule will become effective on January 1, 2016, which is the uniform compliance date for food labeling rules issued between January 1, 2013 and December 31, 2014.  The rule finalizes, without change, a proposed rule that was published in November 2007.

Food Stamp Vendors Face Increased Eligibility Requirements and Oversight Following Implementation of Farm Bill’s SNAP Provisions

By Stewart D. Fried

The 2014 Farm Bill contains several important provisions which will impact retail stores that participate in the USDA Food and Nutrition Service’s (FNS) Supplemental Nutrition Assistance Program (SNAP).  The key changes for food stamp vendors include an increase in the minimum number of staple food items that stores must carry on a continuous basis, that perishable food items in at least three of the four staple food categories must be available for purchase at all times, that SNAP vendors must now bear all of the costs associated with EBT equipment and an important expansion of record-keeping requirements.  On March 21, 2014, FNS issued a preliminary implementation memorandum which advised that most of the SNAP vendor-related provisions will require further rulemaking.  However, several of the new SNAP vendor provisions, including those related to maintenance of purchase invoices and other program-related recordkeeping, are effective immediately.  FNS also intends to release guidance, questions and answers, and technical assistance documents relating to these statutory changes to SNAP.

Retail food stores that are authorized to participate in SNAP should verify that they are complying with these new requirements, especially those related to minimum staple food items and the increased recordkeeping requirements.  SNAP vendors may also be interested in FNS’s establishment of pilot programs for use of online and mobile technologies for redemption of food stamps.  Finally, the Farm Bill provides FNS with an additional $15 million in immediate funding and up to $5 million in additional annual funding for use in combatting trafficking by SNAP vendors and beneficiaries.  Given increased scrutiny in the media and on Capitol Hill regarding trafficking of food stamps by small retailers, SNAP vendors should verify that they have an effective written compliance policy and must conduct adequate and frequent employee training programs.  Proof of written compliance policies and training programs are prerequisites for eligibility for a civil monetary penalty in lieu of permanent disqualification in the event the store is accused of trafficking due to a rogue employee’s sale of food stamps for cash or ineligible items.  Without evidence of a written compliance policy and training program, FNS’s Administrative Review Branch is likely to permanently disqualify stores from participating in the food stamp program – even if store owners did not participate or benefit from any illegal trafficking activities.

Key SNAP Vendor Provisions in 2014 Farm Bill

Increased Variety of Staple Food Items Must Be Carried To Retain Eligibility

§4002(a) amends the definition of “Retail Food Store” by increasing the minimum number of qualifying varieties of foods which SNAP vendors must offer for sale on a continuous basis in each of the four categories of staple foods to seven (up from three). (The four categories of staple foods are meat, poultry or fish; bread or cereal; vegetables or fruits; and dairy products).  §4002(a) also increases the requirement that SNAP vendors carry perishable foods in at least three of the four staple food categories (up from “at least two”).

Imposition of Costs of EBT POS Equipment on Vendors

§4002(b) directs USDA to require SNAP vendors to pay for 100 percent of the costs of acquiring and implementing EBT point-of-sale equipment and related supplies. This new provision contains limited exemptions applicable largely to non-profits and farmers’ markets.

Increased SNAP Vendor Recordkeeping Requirements

§4002(e) amends 7 U.S.C. §2018(c) by increasing the types of records that SNAP vendors may be required to submit to FNS in order to obtain or maintain their SNAP authorization.  Specifically, FNS is permitted, by regulation, to require SNAP vendor applicants to submit purchase invoices and other “program-related records,” in additional to the previously required “relevant income and sales tax filing documents.”  Regardless of what FNS’s forthcoming proposed regulations will seek, these new requirements will, at a minimum, represent a substantial expansion in the scope of records which retail stores will need to maintain in order to keep their SNAP authorization.  Although Congress did not define “program-related records,” it is possible that FNS could propose to require that SNAP vendors maintain all sales receipts.  Any such proposal can be expected to be strongly opposed by virtually all SNAP vendors, due to compliance costs and anticipated logistical difficulties associated with differentiating between SNAP and cash sales.  At the very least, SNAP vendors should now maintain purchase invoices for at least a three-year period of time based upon the statements of the Farm Bill managers in the Conference Report.

Establishment of Pilot Programs for Acceptance of Mobile and Online Transactions

§4011 requires FNS to explore the feasibility of redeeming SNAP benefits through means other than wired point-of-sale technology. FNS is required to establish demonstration projects for utilization of mobile (cellular/wifi) and online transactions for SNAP redemption.  FNS will submit its final reports on these projects to USDA leadership by July 1, 2016, with a report to Congress no later than January 1, 2017.

Additional Funding to Combat SNAP Vendor and Beneficiary Trafficking

§4029 provides FNS with $15 million in immediate funding that remains available until expended to prevent trafficking by food stamp vendors and beneficiaries.  It also authorizes, subject to appropriations, up to an additional $5 million each year between 2014 and 2018, inclusive.  These funds are intended to supplement FNS’s existing efforts to insure that retail stores and recipients maintain program integrity, with a mandatory focus on data mining and use of other information technologies.  FNS’s efforts are expected to be particularly focused on small SNAP vendors.

Other Provisions

The Farm Bill contains many additional SNAP-related provisions which are not expected to impact most retail stores on a day-to-day basis.  These provisions include the elimination of manual vouchers, except in emergency circumstances; establishment of unique EBT Identification Numbers by entities providing EBT transfer services in order to enhance anti-fraud protections. FNS will promulgate the necessary regulations within two (2) years; preparation of a Feasibility Study and Report regarding SNAP on Indian Reservations; declining to reissue EBT cards to SNAP beneficiaries that make excessive requests for replacement cards; and establishment of a least one pilot project to reduce SNAP fraud in one of the ten largest urban areas in the country.

SNAP vendors should closely adhere to these new statutory requirements and stay abreast of new FNS regulations and guidance that relate to the food stamp program.

Can EPA Regulate Animal Operations as Landfills? 1

By John G. Dillard

Four Washington State dairies are the targets of environmental activists in lawsuits that could have far-reaching consequences for animal agriculture in the United States. In these cases, the environmentalists assert that the dairies’ manure storage and application practices violate the Resource Conservation and Recovery Act (RCRA), the federal statute that regulates the disposal of solid and hazardous waste. The crux of the environmentalists’ argument is that manure is a “solid waste” under RCRA if it is not strictly used as a fertilizer applied at agronomic nutrient uptake rates.

The Case

The plaintiffs, Community Association for the Restoration of the Environment (“CARE”) and Center for Food Safety (“CFS”), brought suit against the dairies under RCRA’s “citizen suit” provision. RCRA is generally enforced in the context of sanitary landfills and industrial waste disposal, not agricultural operations. However, the plaintiffs allege that the dairies are violating Section 7002(a) of RCRA by storing, handling, and disposing of manure in a manner that endangers health and the environment. Furthermore, the plaintiffs contend that the dairies’ manure handling activities amount to “open dumping” of solid waste, which violates Section 4005(a) of RCRA.

In additional to seeking recovery of their attorneys’ fees, CARE and CFS are seeking an injunction that would require the dairies to undertake several remedial and preventive actions. Some of these actions include installing synthetic liners in all existing storage lagoons, undertaking an extensive soil and water quality monitoring program, funding independent study to develop a remediation plan, and providing an alternative drinking water source for neighbors within a three-mile radius of the dairies.

Is Manure a Solid Waste?

Manure is generally not considered a “solid waste” for the purposes of RCRA. RCRA defines solid waste as “garbage, refuse . . . and other discarded materials” resulting from commercial and community activities. Manure is not typically discarded, but is instead a useful by-product of animal agriculture. In fact, EPA regulations specifically exempt manure from RCRA if it is “returned to the soil as fertilizers and soil conditioners.”

While recognizing the exemption for manure as a fertilizer, the plaintiffs alleged that manure is a solid waste if it is applied at levels beyond agronomic uptake rates or leaks into groundwater. In other words, the plaintiffs’ case rests on the theory that any manure that is not strictly used as a fertilizer is “discarded” and thus, a solid waste. Using this theory, the plaintiffs alleged that the dairies violated RCRA due to excessive application of manure to agricultural fields that resulted in runoff or leaching into the soil. Furthermore, the plaintiffs alleged that millions of gallons of liquid manure leaked out of the dairies’ lagoons and entered groundwater supplies.

This is not the first time a case has been litigated under this theory. In 2006, EPA sought to hold a swine operation liable under RCRA on the basis that manure applied in excess of agronomic uptake rates was a “solid waste” for RCRA purposes. However, EPA and the swine producer entered into a consent decree, which avoided establishing precedent on the matter. In a separate matter, Oklahoma v. Tyson Foods, Inc., the state of Oklahoma applied the same theory to poultry litter. In that case, the court held that manure applied as a useful fertilizer did not transform into solid waste simply because its entire contents were not absorbed by crops as nutrients. 2010 WL 653032 at *10.

Plaintiffs Have Cleared a Hurdle

The dairies sought to have the cases dismissed on the basis that manure intended for use as fertilizer is not transformed into solid waste in the event it is over-applied to fields or leaked from lagoons. However, in a setback to the dairies, the court rejected this argument. The court did acknowledge that Congress did not intend for manure that is applied as fertilizer to be regulated as a solid waste under RCRA. However, the Court held that it was “untenable” that manure could never transform into solid waste through unintentional excess application or leaking from lagoons.

By surviving the motion to dismiss, the plaintiffs cleared a substantial legal hurdle. The case now rests on whether the plaintiffs can demonstrate that the dairies’ manure storage and application activities actually led to manure runoff and leaching as well as leakage into the groundwater. Whether the facts of the case match the plaintiffs’ claims remains to be seen. For instance, USDA’s Natural Resources Conservation Service was highly critical of EPA’s methodology and conclusions in a study of the dairies’ impact on drinking water; the plaintiffs rely, in part, on this study for their own claims.

Parallel EPA Enforcement

These Washington state dairies are also the subjects of EPA enforcement actions under the Safe Drinking Water Act. EPA targeted the dairies because it believed they were the cause of elevated nitrate levels in drinking water in the vicinity of the operations. EPA initially served Notices of Violation to five Yakima Valley dairies. Rather than face enforcement, one dairy decided to cease operations and sell off its herd. The other four entered into onerous consent decrees, which require the dairies to provide alternative drinking water sources for neighbors within a one-mile radius, install multiple monitoring wells on the property, and conduct a comprehensive assessment that identifies ways to reduce or minimize the impact of the dairies on surrounding water quality.

Implications for Agriculture

Activists often seek to bring ordinary agricultural practices under the purview of RCRA. For instance, in Safe Air for Everyone v. Meyer, several of my OFW Law colleagues represented a group of Idaho bluegrass farmers in another RCRA citizen suit brought by activists over the practice of “open burning” fields, which promotes regeneration of bluegrass and maintains yields after seeds are harvested. In Meyer, the Ninth Circuit held that an agricultural “waste,” such as grass residue, is not a solid waste under RCRA if the generators of the residue (farmers) reuse it  in a continuous system that improves crop yields and is in accordance with established farming practices.

The Washington dairy cases could have major implications for livestock, dairy and poultry operations in the United States. Manure is a valuable by-product and a critical component for ecological and economic sustainability in animal farming operations. Animal agriculture is accustomed to regulation under the Clean Water Act. However, shoehorning livestock, dairy and poultry operations into RCRA, a statute intended to regulate waste storage and sanitary landfills, has the potential to create confusion and possibly duplicative regulations.

I will be following this case and will provide updates as necessary.

FDA/ONC/FCC Health IT Report Signals Possible Deregulation of Certain Software Medical Devices

By Neil F. O’Flaherty

Has the U.S. Food and Drug Administration (FDA) opened the door to deregulation of certain software medical devices?  Its recently issued Health IT Report seems to indicate so, and FDA is seeking comments on the report.  Now is the time to weigh in on what FDA ultimately should do.

Federal law enacted by Congress in 2012 mandated that the FDA, in collaboration with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), develop and post on their websites “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” The report was issued on April 3, 2014, which was somewhat after the statutory deadline.

The proposed strategy and recommendations identify three categories of health IT functionality: 1) administrative health IT functions, 2) health management health IT functions, and 3) medical device health IT functions.  According to the report, each health IT functionality category presents different public health risk levels, driving different corresponding risk controls and measures.  For instance, the proposed strategy and recommendations for the health management health IT framework focuses on four priority areas: 1) promote the use of quality management principles; 2) identify, develop and adopt standards and best practices; 3) leverage conformity assessment tools; and 4) create an environment of learning and continued improvement.  In addition to implementing actions to address these four priorities, the report proposes to establish a public-private Health IT Safety Center.  The proposed framework favors this approach for these types of products as opposed to a formal regulatory/legal framework.

According to the report, certain lower risk clinical decision support (CDS) products can fall under the category of health management health IT functionality, even though they meet the statutory definition of a medical “device.” FDA does not intend to focus its regulatory oversight on such products under the proposed strategy and recommendations.

The report gives the following examples of CDS product functionalities that fall within this catagory: evidence-based clinician order sets tailored for a particular condition, disease, or clinician preference; drug-drug interactions and drug-allergy contraindication alerts to avert adverse drug events; most drug dosing calculations; drug formulary guidelines; reminders for preventative care (e.g., mammography, colonoscopy, immunizations, etc.); facilitation of access to treatment guidelines and other reference materials that could provide information relevant to particular patients; calculation of prediction rules and severity of illness assessments (e.g., APACHE score, AHRO Pneumonia Severity Index, Charlson Index); duplicate testing alerts; and suggestions for possible diagnoses based on patient-specific information retrieved from a patient’s electronic health record.  Traditionally, products with some of these functions have been actively regulated by FDA as medical devices.

Elaborating on CDS products, the report states that they provide health care providers and patients with knowledge and patient-specific information, intelligently filtered or presented at appropriate times, to enhance health care.  According to the report, because the risks of CDS are generally low compared to the potential benefits, FDA does not intend to focus its oversight on most CDS products.  Instead, FDA intends to focus its oversight on a limited set of CDS products that pose higher risks to patients.  The report gives the following examples of higher risk CDS functionalities: computer-aided detection/diagnostic software; remote display or notification of real-time alarms (physiological, technical, advisory) from bedside monitors; radiation treatment planning; robotic surgical planning and control; and electrocardiography analytical software.

The Health IT Report only puts forth a proposal.  It does not necessarily represent where the FDA regulatory framework ultimately will end up. For interested parties with a stake in how various health management health IT products are (or are not) ultimately regulated, now is the time to act and to start influencing the process and decision-making.  With ONC and FCC, FDA is holding a public workshop on the proposed strategy and recommendations May 13-15, 2014, at the National Institute of Standards and Technology in Gaithersburg, Maryland.  FDA has also asked that comments on the proposed strategy and recommendations be submitted by July 7, 2014.

Steps to Prevent Allergen Recalls, Part Two – Another Practice Tip from Ms. Gloom

By Jolyda O. Swaim

In Part One, we discussed using transparencies on the receiving dock as an easy way for personnel to quickly ascertain whether or not the incoming ingredient (at least its ingredient statement) was the same as your specification.  See our earlier blog posting.  In this post, we want to discuss some of the steps a facility may take to ensure that allergens are controlled through product formulation and batching, and finished product labeling.

Formulation and Batching Process

A key in ensuring that your product does not contain an undeclared allergen is to make sure that the “batch sheet” being used at the batching station is correct.  With today’s technology, many companies use computer systems that only permit the most recently-approved batch sheet to be the one available.  There are, however, many facilities still using a hard-copy that was printed off by the Supervisor or designated personnel.  Unfortunately, many times these “hard-copies” find their way into lockers or files where they are “available” the next time that product is run – or three months from now after a formulation change was made.

Many recalls have been the result of an old formulation print-off being used with a new finished product label.  Usually this occurs because someone accidentally used an obsolete batch sheet they had tucked away in a file or in their locker.

Facilities need to ensure that no one maintains copies of batch sheets where one can be inadvertently used.

Personnel should be notified that copies are not to be maintained and all of those “batch sheet hiding places” should be checked for obsolete copies.  Anyone who has spent time dealing with this will know where these places are.  These have included the normal locations – batch employee’s locker – to the not-so-normal – above the suspended ceiling over the batching station.  Make it a point to have a procedure to issue batch sheets as needed and make this easy for those authorized employees needing the batch sheets.  If it is difficult for the employees to get the batch sheet, they will find ways to make it easier – which usually involves making an “unauthorized copy.”

All batch sheets should contain a revision date or formula version number.  When schedules are printed, this information on the formula version should be included.  All responsible personnel should be trained to check that the batch sheet is the correct version listed on the schedule.  This should be a mandated step required to be completed before any actual ingredient batching begins.

Another procedure that will assist in ensuring the proper formulation is used is to have two different employees responsible for staging and batching.  For example, the employee responsible for staging the necessary ingredients uses a batch sheet issued to him and marks this off to ensure the proper ingredients have been staged.  The batching employee then checks off ingredients on his batch sheet.  This provides two (hopefully independent) checks that a batch is being properly formulated and will match its finished product ingredient statement.

Finished Product Labeling

Another reason for undeclared allergens is the use of the wrong finished product label.  While many facilities have this as a CCP, it is still easy to miss a change in an ingredient statement.  I was gloomy when I had an entire shift of beef hotdogs produced using the packaging for a combination beef and pork formula on one of four production lines.  The printing on the beef hot dogs was all in red while the combination product was printed in green.  The QA technician checked the film on all four lines every hour and marked that it was correct on each line – even though the film was green, the product name was wrong, and the formula was different on one line.  Moreover, the two employees on that line packing the hotdog packages into the cases also “looked” at the film.  Remember, people sometimes see what they expect to see, not what is actually there.

One way to prevent a very gloomy day is to train personnel to read the label information out loud during packaging checks.  When you read out loud, you will be concentrating on what you are actually looking at – not what you “expect” to be there.  If the technician had read the product name on the hotdogs out loud, he would have not said the word “beef” on the line in question.  Chances are that the mistake would have been identified at the first check.  This also holds true for ingredient statements or any information that must be reviewed routinely.  Read it out loud to increase your chances of ensuring it is actually correct.

Finally, verification checks should also be done at some frequency to ensure that the batch sheets in use have the latest version number or revision date, and that these also agree with the finished product labeling.  Have a program in place to control formulation changes so that everyone is aware when they will occur.  Control your finished product labeling:  if you receive in “new” film with an updated ingredient statement, literally keep it under “lock and key.”  Do not keep it in regular inventory as there is a good chance it will get used by accident.  Likewise, if you do not use all “old” labeling up before you change your formulation, lock up the remaining inventory.  An employee will need a partial roll of labels and grab that which is the easiest to get.  Make it difficult to grab the “wrong” labels by keeping these (“old” or “new”) out of reach.

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.

FDA Regulation of Ackee Fruit Products

By Michael J. O’Flaherty

Ackee fruit is harvested from the ackee tree (Blighia sapida), which is native to West Africa, but is also found in Central and South America, many Caribbean countries, and southern Florida.  Ackee is an evergreen tree that grows about 10 meters tall, with a short trunk and a dense crown.  Its fruit is pear-shaped.  When it ripens, it splits open to reveal three large, shiny black seeds, surrounded by soft flesh, the edible arilli.  The fruit is rich in essential fatty acids, vitamin A, zinc, and protein.

Canned, frozen, and other ackee products are marketed in the United States, largely to people from Caribbean cultures.  Most of the ackee products in the United States are imported from tropical countries, such as Jamaica, Belize, and Haiti; however, in recent years, there has been interest by a domestic processor(s) to market ackee products in interstate commerce.

The ackee fruit’s seeds and arilli naturally contain the toxin hypoglycin A (a/k/a simply hypoglycin), which drops to negligible levels in the edible portion of the fruit when it is fully ripe.  Hypoglycin may pose a health risk in concentrations above 100 parts per million (ppm), according to an FDA risk assessment.  The presence of hypoglycin in a finished ackee product at levels above 100 ppm can be attributed to improper processing of the product.

FDA Import Alert 21-11 authorizes the agency’s District Offices to detain, without physical examination, all ackee products offered for import, except for those from firms that are identified on a “Green List” included in the Import Alert.  The firms on the Green List have demonstrated to FDA that they have food safety controls in place to ensure that only properly ripened ackees, without seeds or rind, are included in finished products.

FDA also has published a final Compliance Policy Guide (CPG) that provides guidance for FDA staff on the agency’s enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin.  The CPG (section 550.050) recommends seizure or import refusal of canned, frozen, and other ackee products that contain greater than 100 ppm of hypoglycin.  Beginning today, persons wishing to comment on the final CPG may submit electronic or written comments to FDA.

NRDC Issues Report Critical of GRAS Self-Determinations and CSPI Joins in Criticism

By Mark L. Itzkoff

On April 7, 2014, the Natural Resources Defense Council (NRDC) issued its latest report on GRAS self-determinations, entitled Generally Recognized as Secret: Chemicals Added to Food in the United States.  We previously reported on NRDC’s and the Pew Charitable Trust’s prior criticism of the GRAS provision here and here.  The new article reports on a study of GRAS ingredients that NRDC concluded were marketed in the U.S. based on GRAS self-determinations that were either never submitted to FDA or were the subject of GRAS Notifications to FDA that subsequently were withdrawn.  NRDC claims to have identified “275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations.”  The report categorizes the GRAS exemption as “the loophole that has swallowed the law.”  NRDC concludes that “[t]he system is broken and plagued with conflicts of interest,” that a food ingredient cannot be GRAS “if its identity, chemical composition and safety determination are not publicly disclosed,” and that a legislative change to GRAS authorizations is necessary.

In a coordinated effort, the Center for Science in the Public Interest (CSPI) issued an alert to its members, alleging that GRAS self- determinations are a “frightening problem” and asking their supporters to join its “campaign to strengthen FDA’s role on food safety and let them know how shocked and disappointed you are that they have fallen down on the job and put you at risk.”

As an initial matter, we note that there is nothing improper with a company making a GRAS determination and marketing its product based on that determination.  See FDA, Proposed Rule, Substances Generally Recognized as Safe, 62 Fed Reg 18938, 41 (April 17, 1997) (“a manufacturer may market a substance that the manufacturer determines is GRAS without informing the agency …”).  Under Section 201(s) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 USC 321(s), an ingredient that is generally recognized as safe is not a “food additive” and is not subject to the food additive pre-market review requirements.

The NRDC article overlooks several facts that render their conclusions questionable.  Specifically:

  • The identities of GRAS  food ingredients are not unknown;
  • A GRAS determination must be based on “the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient,” 21 CFR 170.30(b); and
  • Foods containing ingredients based on improper GRAS determinations are “adulterated” and subject to FDA enforcement actions.

Several times in the report NRDC claims that the chemical identity of some GRAS ingredients are not “publicly disclosed.”  [NRDC suggests that the acronym GRAS should stand for “Generally Recognized as Secret.]  However, FDA regulations require that all ingredients in a processed food (except for processing aids and other incidental additives) be listed on the label in the ingredient declaration.  21 CFR 101.4(a)(1).  Since the GRAS ingredients will be listed on the label, they are not secret.  Further, since a GRAS determination must be based on published data, 21 CFR 170.30(b), the public is able to review the safety data and make their own determinations as to the safety of the ingredient.

NRDC also implies that substances deemed to be GRAS are less safe than substances cleared through a food additive petition or GRAS Notification.  However, as noted above, FDA regulations require the same evidence for GRAS determinations that are required for food additive petitions.  In addition, FDA requires that this information be published, usually in a peer-reviewed journal, before the GRAS determination is made.  Thus, the data used to support a GRAS determination has undergone an independent evaluation and been found to be suitable for publication before a proper GRAS determination is made.

In the article, NRDC contends that FDA needs more authority to regulate GRAS ingredients.  However, the article never discusses FDA’s current authority and how FDA has acted in the past to control the use of ingredients that may not be GRAS.  Under the FFDCA, a food ingredient that is neither GRAS nor used in accordance with an applicable regulation is an unapproved food additive and is deemed to be unsafe under FFDCA §409(a)(2), 21 USC §348(a)(2).  Any food that contains an unsafe food additive is considered to be adulterated under FFDCA §402(a)(2)(c)(i),  21 USC §342(a)(2)(c)(i) and may not be introduced into interstate commerce.  FFDCA §301(a), 21 USC §331(a).

Over the past few years, FDA has issued Warning Letters to companies it believes are marketing food containing ingredients that are not GRAS.  For example, FDA issued letters to 30 companies on November 13, 2009, asking them to provide data supporting their determinations that caffeine is GRAS for use in alcoholic beverages.  The agency followed up with Warning Letters to 4 companies supplying caffeinated alcoholic beverages on November 17, 2010, questioning the GRAS status of caffeine as an ingredient in their products (see here and here).   FDA’s actions in this matter were highly effective and all of the caffeinated alcoholic beverages have now been removed from the marketplace.  In situations where a food poses a more immediate public health concern, FDA has authority to seize adulterated foods, FFDCA §304(a), 21 USC §334(a).

In coordination with the NRDC article, CSPI issued an alert alleging that GRAS self determinations are a “frightening problem.” The alert included an “infographic” that it claims exposes “the spaghetti-tangle of FDA’s failure to ensure the safety of food additives.”  CSPI asked their supporters to share its material through social media.  The infographic suggests that suppliers can ignore FDA questions regarding GRAS determinations and use the product in food without adequate safety data.  This ignores the fact that, as explained above, FDA has significant authority to prevent such use.

The CSPI infographic also fails to address the primary reason many companies choose to pursue a GRAS self-determination rather than submit a food additive petition or GRAS Notification.  Under the FFDCA, FDA is required to respond to a food additive petition within 180 days.  FFDCA §409(c)(2), 21 USC §348(c)(2).  However, in practice, the review period for most food additive petitions is 3 years or more.  For many companies, the delay incurred by the food additive petition process is unfeasible.

Neither NRDC nor CSPI make a persuasive argument that reform of the GRAS process is needed to protect consumer safety.  Without a clear and significant threat to public health, it appears unlikely that Congress will enact the changes to the FFDCA that would be needed to significantly restrict the ability of companies to make GRAS determinations.

How to Decide When to Challenge GIPSA Enforcement Actions Under the Packers and Stockyards Act

By Brett T. Schwemer

Each year, the USDA’s Grain Inspection, Packers and Stockyards Administration (GIPSA) initiates over one-hundred enforcement actions against packers, dealers, market agencies, live poultry dealers and other regulated entities for alleged violations of the Packers and Stockyards (P&S) Act.  These actions are taken for alleged unfair and deceptive trade practices, or anticompetitive behavior, such as collusion between dealers and packers, or agreements between dealers to alternate bids or refrain from competing on livestock at auctions. GIPSA also brings enforcement actions for other violations of the P&S Act and implementing regulations, such as failure to make full payment promptly, failure to provide a seller of livestock or poultry details of the purchase contract, and failure to register with USDA as a dealer or market agency.

Most of GIPSA’s enforcement actions take the form of “Notices of Violations” or offers of “Stipulation Agreements.”  A Notice of Violation alleges a minor infraction of the P&S Act and simply requests corrective measures.  An offer for Stipulation Agreement alleges minor infractions of the P&S Act, seeks a small civil penalty, and can be resolved informally without the need for an administrative proceeding.

However, enforcement actions can also take the form of “formal administrative proceedings.” Here, the agency files a Complaint before an Administrative Law Judge (ALJ) requesting that the ALJ impose a substantial civil penalty and an Order requiring the regulated entity to cease and desist from engaging in the alleged unlawful activity (i.e., “Cease and Desist Order”).   In the case of dealers and market agencies, the agency might also request that the ALJ issue an Order suspending the dealer or market agency’s P&S registration, without which they can buy and sell livestock.

Faced with an offer of Stipulation Agreement or an administrative Complaint, regulated entities must decide whether to settle the matter by paying a civil penalty and, in the case of Complaints, agreeing to a Cease and Desist Order and possibly a suspension of registration, or challenge the action by requesting an administrative hearing before the ALJ.  This is a difficult decision, and one in which it is necessary that both the regulated entity and its attorney understand the administrative process for challenging GIPSA enforcement actions.

The administrative process for challenging GIPSA enforcement actions is not exactly stacked in the favor of regulated entities (otherwise known as “respondents”).   First, although the respondent is entitled to a hearing before an ALJ, it is important to understand that the ALJ is a USDA employee.  A review of ALJ decisions shows that the ALJ more often than not rules in favor of the agency.   If the ALJ rules in favor of the agency and assesses a civil penalty and a Cease and Desist Order, the respondent can appeal the ALJ’s decision to another USDA employee, the Judicial Officer (JO).  Only after losing at this stage can the respondent appeal the agency’s decision to the United States Court of Appeals in the circuit where the respondent resides.   The Court of Appeals will review the JO’s decision under a deferential standard, reviewing the JO’s conclusions of law de novo, but affirming the JO’s finding of fact if, upon review of the record, they are supported by substantial evidence.

Second, although the respondent has an opportunity to introduce witness testimony and evidence at the hearing before the ALJ and cross-examine GIPSA’s witnesses, respondents have limited opportunities for discovery prior to the Hearing.  Discovery is generally limited to the ALJ ordering the agency and respondent to exchange proposed exhibits and a witness list, which includes a short description of the witnesses’ testimony.  Although GIPSA regulations also allow respondents to request that the ALJ order the issuance of subpoenas or allow depositions, these requests are not granted very often.

This does not mean that the above hurdles make it impossible for Respondents to have success at the ALJ or JO stages of the administrative process.  For example, in one matter in which we represented the respondent, the ALJ found that our client violated the P&S Act but denied GIPSA’s request to impose a civil penalty of more than $1,000,000 (and issued no civil penalty) because the ALJ determined that our client’s action was unintentional, and GIPSA did not put our client on notice that its conduct would have violated the P&S Act.  Notwithstanding, the above hurdles should be considered when contemplating whether or not to challenge a GIPSA enforcement action.

Respondents should also consider the following additional factors:

  • What is the likelihood of success at each level of the administrative process and at the Court of Appeals?
  • What will be the legal costs involved in challenging the enforcement action at each step of the process?
  • How much would the civil penalty be if the case was settled compared to how much it would be if the case went to a hearing and the respondent loses? How does the projected civil penalty compare to the estimated legal costs?
  • If a Cease and Desist Order is issued, how onerous would it be to comply with the Order (violations of a Cease and Desist Order can be prosecuted as a criminal offense)?
  • In the case of dealers and market agencies, is GIPSA seeking to suspend registrations, without which they can conduct business? If so, how long would the registrations be suspended?
  • How would sellers or buyers of the regulated entity respond if the regulated entity agreed to settle a GIPSA enforcement action or was found by the ALJ, JO or Court of Appeals to have violated the P&S Act (GIPSA will issue press releases announcing impositions of civil penalties and Cease and Desist Orders)?

Only the regulated entity can make the decision whether it is worthwhile to contest a GIPSA enforcement action or to settle it.  However, to fully consider the factors above and make a sound business decision, the entity would be well advised to seek advice from someone who fully understands the administrative process, P&S precedent in similar enforcement proceedings, and the GIPSA employees who are involved in the administrative process.  Making a decision to fight cases that have an unlikely chance of success results in the business paying far more money in legal costs than the civil penalty ultimately imposed.  Making a decision simply to accept the GIPSA complaint has downsides as well – payment of an excessive penalty or agreeing to a unsupportable cease and desist can have an adverse effect on your business.

FDA Issues Guidance on Labeling of Honey

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a draft guidance document on labeling of honey and honey products.

According to FDA, “honey” is the common or usual name for “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.”  The floral source of honey may be included on the label (e.g., “orange blossom honey,” “clover honey”), provided that (1) the particular plant or blossom is the chief floral source of the honey; and (2) the producer, manufacturer, processor, packer, or distributor can show that the designated plant or blossom is the chief floral source.  See also Compliance Policy Guide Section 515.300 (Honey – Source Declaration).  Honey, when sold as such, is a single-ingredient food and does not need to bear an ingredients declaration.

Only products made exclusively of honey may be called “honey.”  A product consisting of honey and another sweetener must bear a common or usual name that accurately describes the product (e.g., “blend of honey and sugar” if honey is the predominant ingredient, or “blend of sugar and honey” if sugar is the predominant ingredient) and include an ingredients declaration listing its ingredients in descending order of predominance by weight.  Similarly, a product consisting of honey and another ingredient, such as a flavoring, must bear an appropriate common or usual name (e.g., “raspberry flavored honey”) and an ingredients declaration that lists the other ingredient(s).

There have been some reports in recent years claiming that much of the honey on the market is not real honey (see, e.g., Andrew Schneider, Tests Show Most Store Honey Isn’t Honey, foodsafetynews.com, Nov. 7, 2011).

The draft guidance discusses FDA’s enforcement authority and notes that passing off diluted products as honey may result in both misbranding and adulteration (i.e., economic adulteration) charges. FDA also has several import alerts relevant to imported honey, including an import alert for honey adulterated with corn or cane sugar (Import Alert 36-01) and an import alert recommending detention without physical examination for honey that appears to contain unsafe drug residues (e.g., chloramphenicol, fluoroquinolones) (Import Alert 36-04).

The draft guidance notes that FDA received a petition from the American Beekeeping Federation in 2006 requesting the agency to establish a standard of identity for “honey” based on the Codex Alimentarius Commission’s standard for honey, but FDA concluded that a standard of identity was unnecessary and denied the petition.  FDA believes the integrity of honey can be protected under existing laws.

A few states have enacted their own standards of identity for honey that impose additional restrictions beyond those in FDA’s draft guidance.  For example, Utah’s standard of identity for honey provides that it may “not be heated or processed to such an extent that its essential character is changed or its quality is impaired.”  Utah Administrative Code Sec. R70-520-4.  In the absence of a federal standard of identity, there is no federal preemption of such state laws.