Mandated Labeling for Genetically Engineered Foods: Vermont’s Legislation Implicates the First Amendment

By Robert A. Hahn and John G. Dillard

Note: OFW Law’s Bob Hahn and John Dillard recently authored a legal backgrounder on the First Amendment implications of Vermont’s new genetically engineered food labeling law for the Washington Legal Foundation, a widely respected non-profit legal organization.

Vermont has become the first state to require labeling of genetically engineered foods. On April 23, 2014, Vermont’s legislature approved a bill (H.112) that would require raw agricultural commodities and processed foods offered for sale in Vermont retail stores, with certain exceptions, to bear special labeling if they are entirely or partially produced with genetic engineering. Governor Peter Shumlin signed the bill into law on May 8, 2014, and the labeling requirement will become effective on July 1, 2016.  Vermont is now at the tip of the spear in the movement to require labeling on foods containing ingredients that are commonly referred to as “genetically modified organisms” or “GMOs.”

Although this legislation apparently enjoys broad popular support in a state known for embracing organic farming techniques and the local food movement, it is vulnerable to a constitutional challenge under the First Amendment. While the U.S. Court of Appeals for the Second Circuit is a particularly hospitable court for Vermont to make its case, it is not clear that even the Second Circuit would uphold this law if challenged. Moreover, even if the law is upheld by the Second Circuit, there is a good chance that the U.S. Supreme Court would grant certiorari to an appeal, given    the existence of a pronounced split among the circuit courts on the proper standard to be applied in First Amendment review of this type of labeling law.

Click here to read the rest of Bob and John’s Washington Legal Foundation article.

FDA Announces Public Meeting on Nutrition Labeling Proposed Rules

By Robert A. Hahn

The Food and Drug Administration (FDA) has announced a public meeting on June 26, 2014 to discuss its two pending proposed rules to update the Nutrition Facts label (and the Supplement Facts label for dietary supplements).  Those proposed rules are:

  • Food Labeling: Revision of the Nutrition and Supplement Facts Labels
  • Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments

See our February 27th blog post on the proposed rules here.

Given the extensive changes being proposed, a public meeting would seem to be appropriate.  The stated purpose of the meeting is to inform the public of the proposed changes and the rulemaking process, to respond to questions about the proposed rules, and to hear oral comments.  The transcript of the meeting will become part of the rulemaking’s administrative record.  The transcript and a video recording of the meeting will be made available at and

The meeting will be held in the U.S. Department of Agriculture’s Jefferson Auditorium, Wing 5, 14th and Independence Avenue, SW, Washington, DC 20024 on June 26th from 8:30 am to 5:00 pm.  The meeting also will be webcast live for those unable to attend in person.  Information about how to register to attend in person or via webcast, how to request a time slot to make an oral presentation, and other details can be found here.  Requests to make oral presentations must be submitted by June 12th.  The comment period for the proposed rules has been extended and will close on August 1st.

Are You Prepared for An FSIS Compliance Visit?

By Brett T. Schwemer

Last month, the Food Safety and Inspection Service (FSIS) reissued seven Directives relating to FSIS surveillance, investigation and enforcement activities.  The Directives are available here.

Together, these Directives provide a comprehensive set of instructions to FSIS investigators and other personnel for conducting surveillance activities and investigations to determine a regulated entity’s compliance with the Inspection Acts and related laws.  The Directives instruct investigators on how to collect evidence, such as accessing establishment records, taking photographs, collecting investigative samples, and interviewing and taking statements from subjects and witnesses.  The Directives also provide instructions for determining appropriate enforcement actions for alleged violations of the Acts.

While FSIS investigators have detailed written procedures to follow, most establishments do not have similar procedures for handling government investigations or the enforcement actions that might arise out of them.  Because of this, too often establishments and their employees allow investigators unbridled freedom to collect evidence, such as signed statements, without the establishment’s rights or other interests being protected.  Unfortunately, establishments and their employees often do not recognize what they have done until they are faced with an enforcement action by the agency.

All establishments regulated by FSIS should have written procedures regarding how to handle government compliance visits and investigations.  The procedures should cover, at a minimum:

  • How to receive compliance officers, such as how to verify government credentials and how to notify establishment management when compliance visits occur outside of normal business hours;
  • How to communicate company policies to investigators, such as the requirement that a company escort accompany the investigators at all times during the visit and that investigators follow establishment GMP and food safety procedures;
  • How to handle requests for records, such as the requirement that all document requests be channeled through one person and approved by company management (with input from legal counsel as needed);
  • How to respond to the agency’s collection of investigative samples, such as documenting what, when, where, how and why samples were taken and holding all products potentially implicated;
  • How to respond to requests for photographs, which could include prohibiting photographs unless certain conditions are met and contacting legal counsel in the event investigators decline to comply;
  • How to respond to requests for interviews and employee statements, such as requiring that all employee interviews take place on company premises with a company official or counsel present, and that no statements or documents be reviewed, signed, initialed, or in any way approved (including verbally) by an employee until it is first reviewed by legal counsel; and
  • How to conduct an exit interview with the investigators to determine areas of potential concern and corrective/preventive measures.

The establishment’s written procedures should also address how to respond to follow-up actions by FSIS, including promptly alerting management of any enforcement action that may be contemplated or taken by the agency. Particular attention should be given to FSIS letters titled “Notice of Alleged Violation.”  These letters allege criminal violations of the Acts and other laws, and provide establishments and/or individuals an opportunity to respond in writing – and request a meeting to discuss – the alleged violations before the agency decides whether to refer the matter to a U.S. Attorney’s Office for criminal prosecution.  Because anything said or written in response to these letters may be used against an establishment or individual in a criminal proceeding, it is strongly recommended that persons receiving this letter obtain legal representation prior to responding.

One final piece of advice: do not take it on faith when an investigator claims that the matter he/she is investigating is “minor” or not a “big deal.”   Minor issues normally do not result in an investigators showing up at your footstep.  If you believe that it is possible that the establishment or one of its employees may be the subject of a criminal investigation, seek legal representation at the point when it really matters — at the beginning of the investigation and not after all the evidence is collected and an enforcement action is taken.

Note: This article will be published in the June 2014 issue of The National Provisioner.


FDA Extends Comment Period for Proposed Rules on Nutrition Labeling

By Robert A. Hahn

FDA has announced a 60-day extension of the comment period for two major proposed rules on nutrition labeling. The extended comment period will close on August 1, 2014.

In March, FDA published two proposed rules on nutrition labeling: one a major overhaul of the Nutrition Facts and Supplement Facts panels, and the other updating the reference amounts customarily consumed (RACCs) and serving sizes used in nutrition labeling. See our February 27th post on the proposed rules here. Since then, FDA has received many requests for an extension of the original 90-day comment period.

The proposed rules would make significant changes to nutrition labeling requirements, including the following:

  • Require declaration of Added Sugars;
  • Define Dietary Fiber for the first time;
  • Change the four micronutrients of public health significance that must be declared to Vitamin D, Calcium, Iron, and Potassium;
  • Revise the Daily Values for certain nutrients;
  • Require maintenance of records to substantiate certain nutrient declarations (e.g., Added Sugars, Dietary Fiber) and authorize FDA inspection of those records;
  • Require foods that are packaged and sold individually and contain 200% to 400% of the applicable RACC to present nutrition information for both the serving size and the entire package (i.e., “dual column” labeling); and
  • Significantly alter the “look” of (i.e., the graphic requirements for) the Nutrition Facts panel.

Although the proposed rules deal with nutrition labeling, they may affect other information on food labels. For example, the proposed changes in RACCs and Daily Values may affect whether a food is eligible to make a nutrient content claim or health claim. The proposed graphic changes to the Nutrition Facts panel may also reduce the amount of label space available for other information. We recommend that all food companies understand how the proposed rules, if finalized, would impact their products.

Senate Ag Appropriations Subcommittee Reports FY 2015 Bill Without Amendments–Discretionary Spending Allocation Lower than Amount Provided to House

By Roger R. Szemraj

The Senate Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee also voted today by voice vote to approve its draft FY 2015 bill and report it to the full Senate Appropriations Committee.  The full Committee is scheduled to consider this bill on Thursday, May 22.  Neither the bill text nor the Committee report are yet available, but should be within the next two days.  The Committee’s summary of the bill can be found here.

Subcommittee Chairman Pryor (D-AR), in his opening statement, said the Subcommittee’s allocation is $20.575 billion, which I note is lower than the $20.88 billion provided to the House Subcommittee. He highlighted several specific items, including:

  • $85 million for the Emergency Watershed Protection Program and $15 million for the Emergency Forestry Restoration Program;
  • $6.623 billion for the WIC program, which fully funds participation;
  • The budget request levels for the Commodity Supplemental Food Program, the Farmers Market Nutrition Program and the Emergency Food Assistance Program;
  • $25 million to help local school districts purchase new food service equipment;
  • $1.466 billion for the PL 480 Food for Peace Program, the same as fiscal year 2014;
  • $1.139 billion for the Agricultural Research Service, which is $17 million above fiscal year 2014;
  • $1.292 billion for NIFA, which is $15 million above fiscal year 2014. including $325 million for the Agriculture and Food Research Initiative, $244 million for Hatch Act, and $300 million for Smith-Lever funding;
  • $2.588 billion for the Food and Drug Administration, which is $36 million above fiscal year 2014, providing all of the funding changes requested in the budget, including an increase of $23 million for implementation of the Food Safety Modernization Act (FSMA); and
  • $1.023 billion for the Food Safety and Inspection Service, which includes full funding for all federal, state and international inspection services.

Subcommittee Ranking Member Blunt complimented Chairman Pryor for the bill, and said that the full Senate is expected to take up the bill later this summer.

No amendments were offered during this markup, with the expectation that they are being held until Thursday’s full Committee session.  Senator Collins (R-ME) announced that she intends to offer an amendment to include white potatoes in the WIC program, saying that the USDA rule is not based on the most recent nutritional data regarding the value of white potatoes.    Senator Hoeven (R-ND) said he will offer amendments regarding the school lunch program.  Those are expected to deal with upcoming requirements for the use of 100 percent whole grain rich items in the program, as well as concerns about further changes in sodium standards.

USDA Offers Guidance on “Made with Organic ___” Label Claims

By Robert A. Hahn

The National Organic Program (NOP) of the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) has issued a final guidance document on “made with organic ___” labeling.  The guidance became effective on May 2, 2014.

The guidance document explains that the claim “made with organic ___” may be made if the following conditions are met:

  1. The product contains at least 70 percent organic ingredients (excluding water and salt) (see 7 C.F.R. § 205.301(c));
  1. The remaining ingredients (up to 30 percent, excluding water and salt) may be non-organic, but any non-agricultural ingredient must be allowed on the National List of Allowed and Prohibited Substances (the National List found at 7 C.F.R. § 205.605); and
  1. None of the ingredients may be produced using excluded methods, i.e., genetic engineering, ionizing radiation, or sewage sludge (see 7 § C.F.R. 205.105).

In addition, operations that grow, handle, or process “made with organic ___” products must be certified as organic by an accredited certifying agent, unless subject to an exemption or exclusion from that requirement.

The guidance document also clarifies the permissible wording of the claim, as well as accompanying label statements:

  • The claim must identify up to three organic ingredients or food groups present in the product (e.g., “made with organic vegetables, rice and beans”).  If a food group is identified, only the following food groups may be listed: beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, vegetables and processed milk products.
  • If an ingredient or food group is identified as organic, then all raw and processed forms of ingredients from that ingredient or food group must be certified organic.  For example, if the claim states “made with organic corn,” then all corn-based ingredients (e.g., corn oil, cornstarch, corn syrup) must be organic.  (There is an exemption in the case of poultry in pet food.)
  • If the claim “made with organic [up to 3 ingredients, food groups, or combination of ingredients and food groups]” is made, the label may also declare the percentage of organic ingredients in the finished product (e.g., “75% organic,” “contains 90% certified organic ingredients”).  However, a percentage organic statement (e.g., “made with 70 percent organic ingredients,” “made with organic ingredients”) may not appear by itself; it must be accompanied by the claim “made with organic [up to 3 ingredients, food groups, or combination of ingredients and food groups].”
  • All words used in the claim and the percentage organic statement must appear in the same format (i.e., the same type size, style, and color) without highlighting, and must be no more than half the size of the largest text on that label panel.
  • The ingredients declaration must identify all certified organic ingredients as “organic.”  If the product contains both organic and non-organic forms of the same ingredient, they must be listed separately in the ingredients declaration.
  • The statement “Certified organic by [name of certifying agent]” must appear below the signature line.  The certifier’s seal or logo may also be presented.
  • The USDA organic seal may not appear on the label.

The NOP has also issued two related documents: examples of permissible and impermissible “made with organic ___” claims and responses to comments received regarding its 2011 draft guidance.

Fishy Fishy – MOU between FSIS and FDA to Improve Interagency Cooperation

By Barbara J. Masters, D.V.M.

There have been on-going questions regarding the regulatory oversight of catfish inspection.  To address this concern, the 2014 Farm Bill required the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) to create a Memorandum of Understanding (MOU) to “improve interagency cooperation on food safety and fraud prevention and to maximize the effectiveness of personnel and resources related to examination of Suluriformes fish and fish products.”  The Agencies signed the MOU on April 30, 2014.

Currently, the FDA inspects all fish and fish products.  The 2008 Farm Bill transferred the regulatory authority for the inspection of catfish to FSIS.  FSIS has not yet begun to inspect any catfish; however, in 2011 it issued a Proposed Rule for mandatory catfish inspection.

One of the most controversial areas regarding the transfer of authorities was the “definition of catfish.”  The 2011 Proposed Rule considered two possible definitions:  (1) fish belonging to the family Ictaluridae, and (2) a broader definition of all fish of the order Siluriformes.  The broader definition includes fish in the Pangasiidae family, which are produced in Asia, such as basa, tra and swai.  The 2014 Farm Bill requirement for the MOU makes clear that the broader definition is to be adopted, and that FSIS is to be the primary regulatory authority for all fish of the order Siluriformes.

The MOU indicates that the two regulatory agencies are to follow existing dual jurisdiction procedures for those establishments that handle both Siluriformes fish and fish products as well as other fish and fish products.  The agencies are also to exchange information with regards to regulatory oversight.

We understand that the FSIS Final Rule for mandatory inspection of catfish will be submitted to the Office of Management and Budget in the very near future.  We anticipate that the final rule will contain provisions similar to the proposed rule.  Specifically, as proposed, the facilities would be required to obtain an official grant of inspection and be operated in a sanitary manner.  In addition to Sanitation Standard Operating Procedures (SSOP), Hazard Analysis Critical Control Point (HACCP), Salmonella Performance Standards, Ready-to-Eat performance standards, carcass dispositions, and labeling requirements, these facilities would have transportation and pre-harvest requirements to meet.  Most notably, the facilities would have FSIS continuous inspection.

It should be noted that by broadly defining the definition of catfish to include the Siluriformes fish and fish products, there will be regulatory and inspection consistency between the domestic producers and all importers for all fish within this Order.   With the broader definition of catfish, there is a possibility that it may take several years for importing countries to establish equivalency programs for these products. So while the MOU should facilitate interagency cooperation, there are some concerns that importing countries will view this transfer of regulatory authority as an unnecessary trade burden.

House Agriculture Appropriations Subcommittee Reports FY 2015 Bill Without Any Amendments 1

By Roger R. Szemraj

The House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee today voted  by voice vote to approve its draft FY 2015 bill and report it to the full House Appropriations Committee.  The full Committee is expected to consider this bill on Thursday, May 29, with the goal of having the bill on the House floor in early June.   Chairman Aderholt’s formal opening statement can be accessed here.  The Committee report is not yet available and will not be until full Committee consideration.  The Committee’s summary of the bill and a link to the text of the bill can be found here.

Matters receiving the greatest attention during today’s session included providing USDA with the authority to waive requirements for compliance with school meal rules for those school food authorities that can demonstrate a net loss from operating a food service program for a period of at least 6 months, beginning July 1, 2013 (Section 739); inclusion of white potatoes in the WIC program (Section 738), and funding reductions proposed for the Commodity Futures Trading Commission.

Subcommittee Chairman Robert Aderholt (R-AL), in his opening statement, said that the subcommittees budget allocation is $20.88 billion for discretionary spending – the same amount as provided for FY 2014.  The subcommittee received more than 3,900 requests from 326 Members regarding programs covered by the bill.  Chairman Aderholt specifically raised his inclusion of the school food rule waiver, saying that the provision of this authority is in response to Secretary Vilsack having testified that USDA did not have the authority to grant the waivers called for in the report accompanying the FY 2014 Consolidated Appropriations Act.

Ranking Subcommittee Member Farr (D-CA) described the measure as a “90-10 bill” in that he can support 90 percent, but has to swallow 10 percent.  He specifically disagreed with the inclusion of the school meal rule waiver authority, saying schools would be allowed to opt out of complying with the rule but would be able to keep the extra six cents per meal provided under the Healthy, Hunger-Free Kids Act of 2010.  He also disagreed with the WIC provisions requiring white potatoes, and said the funding level for CFTC  would wreck the agency and is very dangerous.

Full Committee Chairman Rogers (R-KY) said it is his intention to pass all bills individually, and that this is the earliest ever that appropriations bills are being considered thanks to last year’s budget agreement. His specific comments regarding the bill focused on the epidemic of prescription drug abuse, and he praised provisions in the bill calling on FDA to hasten the development of abuse deterrent formulations.

Full Committee Ranking Member Nita Lowey (D-NY) focused her remarks on funding for international food aid and food safety.   She said she is disappointed that the bill does not provide the new authority to use up to 25 percent ($350 million) of the P.L. 480 Title II appropriation in emergencies for interventions such as local or regional procurement of agricultural commodities near crises, food vouchers, or cash transfers requested by the Administration, nor does it provide the $80 million for local and regional food purchases authorized by the Farm Bill.  She also expressed her disagreement with the WIC language regarding white potatoes, saying that the WIC standards have been based on scientific recommendations made by the Institute of Medicine.  She also opposes language in the bill included as part of the funding for child nutrition programs that limits the summer feeding program to rural areas.

Congresswoman Rosa DeLauro (D-CT) said that while she appreciates the challenges of putting together this bill based on her time as chairwoman of the subcommittee, she feels that she must oppose this bill because of concerns for protecting consumers.  She specifically spoke about her belief that the funding level for the Food Safety and Inspection Service is below the FY 2014 amount, and is predicated on unproven and unsubstantiated savings from revisions in poultry inspection procedures.  She argued that more funding should be provided to implement the Food Safety Modernization Act (FSMA), given that she knows the subcommittee will never authorize user fees and the work under FSMA is so important.  She also raised concerns similar to those raised by others regarding funding for CFTC, school meal rule waivers, the WIC food package, and the summer food program.  She said budgeting is about values and choices, and she disagrees with the choices being made in the bill.

Congresswoman Chellie Pingree (D-ME) also raised her objections to the provisions regarding the waiver of school meal nutrition standards, and for language blocking the implementation of the GIPSA rule regarding the marketing of livestock and poultry.

In further discussion regarding the school meal rule waiver, Chairman Aderholt said that representations that the language included in the bill is in response to industry are mischaracterizations.  He said that he has not talked to industry, but instead has heard this request from school lunch personnel in his area.  If others disagree with the waiver, they do not need to apply for it.  Congressman Farr responded that USDA has reported that 90 percent of school food authorities are in compliance with the new meal standards.  USDA should partner with the others to help them achieve compliance.  He dislikes the fact that there is no requirement that schools notify parents that they are seeking waivers from these rules, and believes that if there was such a requirement parents would object.  Chairman Rogers also said that students are saying that they do not want the food that is being served, so they go elsewhere.  In the end, the rules may be hurting more than helping improving the quality of foods consumed by students.  Congresswoman DeLauro continued to argue that more time is needed for making these adjustments and that students will benefit from the fruits and vegetables being included.

For Drought-Hit Farmers, USDA’s Federal Crop Insurance Can Help, But Only If You Understand the Rules

By Kenneth D. Ackerman and Elliot Belilos

The severe drought that had plagued the American Southwest over the past three years – the worst in modern memory – has taken a toll on many local businesses, taxpayers, and homeowners, but among its worst casualties have been American farm producers.

USDA’s Federal crop insurance program, run by the Federal Crop Insurance Corporation (FCIC), was created by Congress during the 1930s dust bowl to help farmers in exactly this situation.  FCIC crop insurance pays farmers indemnities for drought-related losses in many forms, from direct crop damage to failure of irrigation systems to prevented planting, so long as the damage actually stems directly from the inadequate rainfall.

But FCIC coverage has limits, and it’s vital for farmers to know them in advance.  For instance, farmers using irrigation systems can qualify for better coverage than those who do not.  Irrigated farmers benefit from higher yields, and thus higher insurance yield guarantees based on their actual production history (APH).   Even here, though, there are limits.  FCIC rules require that, for a farmer to claim an irrigated “practice,” he must be able to prove a “reasonable expectation” of adequate irrigation water at the time he plants the crop.  If not, coverage can be denied, even if the problem is not discovered until after the fact.

Usually, this rule works smoothly.  It was designed to prevent farmers from planting a crop when they knew that their irrigation system would likely be turned off during the coming year – a situation that exists today in many Southwest states.  Most irrigation systems are fed by waters from melting snowpack or state-regulated aqueducts, so farmers can have plenty of advance notice if the system is likely to fail.

This is not always the case, though.  In Southwest Oklahoma, for instance, over 200 cotton farmers depend on annual irrigation water from Lake Altus, a lake fed by rainfall that historically comes during the growing season – not beforehand.  As a result, applying the rule to them can create confusion.  On one hand, these growers have 68 years of detailed historical records showing that annual post-planting rainfalls are consistent and reliable.  But, on the other, the technical FCIC rule itself appears to require virtual certainly.  It says: “If you know or had reason to know that your water may be reduced before coverage begins, no reasonable expectation exists.”

Can any farmer in this situation actually meet this test, regardless of how reliable his irrigation has been historically?  Can he flatly say at the time he plants a crop that there is no hypothetical “reason to know” that his irrigation water conceivably “may be reduced” at some point in the future?  No one can predict the weather with certainty.  This is why we have insurance.

As a result, in 2013, when these 200 cotton growers in Southwest Oklahoma suffered drought losses and filed claims with the four insurance companies that service their region for FCIC,  they were greeted with a range of responses.   Only two of the companies (those with the smallest number of policies) paid relatively quickly.  The company with the lion’s share of policies declined to pay at all, and the final company paid several months after the loss, and then only with a caveat that the indemnities might need to be returned.  (We represented the growers whose policies had been denied.)

Ultimately, FCIC took the view that each individual insurance company was responsible for determining for itself whether “reasonable expectation” of rainfall existed, and stated that it would support each company in its decision.  This allowed for claims to be settled, but the underlying issues remain open for 2014.

RMA has already indicated plans to clarify the “reasonable expectation” rule, and we strongly encourage it to do so.  But as drought continues to worsen in the Southwest through 2014, the principal duty is on farmers to understand the rules and follow them.

For questions about FCIC drought coverage, or crop insurance generally, please feel free to contact us here at OFW Law.

FDA Explains How to Exempt an Ingredient from Allergen Labeling

By Robert A. Hahn

The Food and Drug Administration (FDA) has published a draft guidance document explaining what information it is looking for in petitions and notifications to exempt ingredients from allergen labeling.  Comments on the draft guidance are due September 5, 2014.

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA), which amended the Federal Food, Drug, and Cosmetic Act to require labeling of “major food allergens.”  FALCPA defines a “major food allergen” as:

(a) milk, egg, peanuts, tree nuts, wheat, soybeans, fish, and crustacean shellfish; and

(b) a food ingredient that contains protein derived from any of the 8 foods in (a), except for highly refined oils and ingredients derived from highly refined oils.

FALCPA also created two mechanisms for exempting ingredients from the allergen labeling requirement.  Any person may petition FDA to exempt a food ingredient from allergen labeling based on scientific evidence demonstrating that the ingredient does not cause an allergic response that poses a risk to human health.  In addition, any person may submit a notification to FDA based on either scientific evidence showing that the ingredient does not contain allergenic protein or a previous determination by FDA under Section 409 that the ingredient does not cause an allergic response that poses a risk to human health.  Inventories of petitions and notifications submitted to FDA, and the agency’s responses, can be found here and here.  Most have met with FDA rejection.

Perhaps because of that, FDA is now offering recommendations on how to prepare petitions and notifications to exempt ingredients from allergen labeling.  For purposes of the draft guidance document, an ingredient is any substance intentionally added to food that either:

  • Is derived from a major food allergen (e.g., through mechanical, chemical, biochemical, or bioengineering processes) and contains proteins or peptides; or
  • Is an organism, enzyme, or “other complex mixture” that is grown or prepared using a major food allergen.

A petition is appropriate where an ingredient derived from a major food allergen may contain allergenic proteins, or derivatives of allergenic proteins, such as peptide fragments, but the ingredient does not cause allergic reactions that pose a risk to human health in food allergic individuals.

A notification is appropriate where an ingredient may contain proteins or protein fragments derived from a major food allergen but the ingredient does not contain allergenic protein.  Presumably, if an ingredient contains no proteins whatsoever, it is excluded from the statutory definition of “major food allergen” and is automatically exempt from allergen labeling (without the need for either a petition or notification): “We are aware that a limited number of technologies (e.g., distillation) may be able to produce protein-free ingredients because of the nature of the process and fundamental biochemical properties of proteins, peptides, and amino acids.”

The draft guidance provides considerable detail regarding the information FDA expects in both petitions and notifications, including: a complete description of the ingredient, the manufacturing or preparation process, chemical and biological characterization of the ingredient (and particularly the proteins and peptides in the ingredient), the intended use of the ingredient in food, the analytical methods used to characterize the ingredient, and an environmental assessment or claim of categorical exclusion.

The draft guidance also provides recommendations for additional information to be included in petitions and notifications.  Petitions should include information on consumer exposure and either clinical testing (e.g., by oral food challenge, skin prick testing, or in vitro testing using serum from allergic individuals) or risk modeling to show that the ingredient does not cause an allergic reaction that poses a risk to human health.  Appendix 1 to the draft guidance explains FDA’s thinking on what constitutes an allergic reaction that poses a risk to human health.  In general, any objective reaction (e.g., vomiting, wheezing, hives) in a clinical trial should be considered indicative of a risk to human health.  Subjective symptoms (e.g., itching, mild nausea, GI discomfort) should not be considered indicative of risk to human health; however, subjective symptoms that are sufficiently serious to stop a dose escalation study or that are associated with objective reactions at higher doses may be considered allergic responses that pose a risk to human health.

For notifications that seek to show that an ingredient does not contain allergenic proteins, FDA recommends including a complete characterization of the proteins and peptides in the ingredient, as well as in vivo or in vitro clinical data demonstrating that the ingredient does not contain allergenic protein.