USDA Ag Outlook Forum Tomorrow

Don’t miss our very own Ken Ackerman at the 2013 USDA Agricultural Outlook Forum tomorrow, February 21, moderating the panel discussion on Managing Financial Risk in Agriculture.  Appearing with Ken will be:

  • Juan Garcia, Administrator, Farm Service Agency, USDA
  • Joel Nelsen, President, California Citrus Mutual, Exeter, California
  • Denny Everson, President of Agriculture, Branch Administrator, First Dakota National Bank, Yankton, South Dakota
Click graphic for more information on the Forum and/or to register.

Click graphic for more information on the Forum and/or to register.

“Alcohol Facts” Becomes a Reality: FTC Requires Four Loko To Label Its Product

By Richard L. Frank and Robert A. Hahn

Nutrition Facts, Supplement Facts, Drug Facts…… Alcohol Facts?  For a number of years, alcoholic beverages have been the only category of consumable product that does not bear basic product information in a consumer-friendly form.  Conventional foods have Nutrition Facts; dietary supplements have Supplement Facts; and OTC drugs have Drug Facts.  But, alcoholic beverages have…. mystery. While most (but not all) alcoholic beverages are required to list percent alcohol by volume (%ABV) or proof, you have to perform mathematical calculations in your head to know how many standard drinks you have consumed.

On February 12th, the Federal Trade Commission (FTC) issued an order that may dramatically alter the beverage alcohol labeling landscape.  To settle a complaint against Phusion Projects, LLC, the maker of Four Loko, the FTC has issued an order that requires Four Loko flavored malt beverages containing more than two servings of alcohol to carry an “Alcohol Facts” panel on the back of the container. The Alcohol Facts panel must include the beverage’s serving size, number of servings per container, container size, %ABV, and the following statement: “According to the U.S. Dietary Guidelines, a serving contains 0.6 ounces of pure alcohol.”

Alcohol Facts

While the Alcohol & Tobacco Tax and Trade Bureau (TTB), the agency that regulates labeling of alcoholic beverages, must approve the Alcohol Facts panel on Four Loko labels, one would think that the FTC cleared this requirement with the TTB before including it in its order.  And if TTB approves the Alcohol Facts panel on Four Loko labels, that should open the door for other bottlers to use it on their products voluntarily.

Why is this important?  The Alcohol Facts panel will enable consumers to easily determine how many standard drinks are in a can or bottle.  For example, if the Alcohol Facts panel says a can or bottle contains 4 servings and that each serving contains 0.6 ounces of pure alcohol (i.e., a standard drink), then a consumer knows that the product contains the alcohol equivalent of four regular beers, four glasses of wine, or four shots of distilled spirits.  With this information, consumers can better modulate their alcohol intake.

Alcohol Facts labels will enable consumers to:

  • Follow the Dietary Guidelines advice on moderate drinking. The Dietary Guidelines recommends that men consume no more than two, and women no more than one, drink(s) per day on average.  A drink is defined as the amount of beer, wine, or spirits that contains 0.6 ounces of pure alcohol.
  • Follow the FDA’s warnings on aspirin and acetaminophen, which state: “If you consume 3 or more alcoholic drinks per day, ask your health professional whether you should take acetaminophen or other pain relievers…”
  • Avoid the many problems associated with over-consumption of alcohol, including alcohol abuse and drunk driving.

Almost ten years ago, the consumer groups National Consumers League, Consumer Federation of America, Center for Science in the Public Interest, and Shape Up America! petitioned TTB to require an Alcohol Facts panel on labels of all alcoholic beverages.  TTB published a proposed rule in 2007, received literally thousands of comments from the public in support, but never finalized it.  It’s possible the FTC order may give the TTB rulemaking new life.

FY 2012 Clinical Investigation Objectionable Activities/Enforcement Trends

By Evan P. Phelps

Forewarned is forearmed. For FDA-regulated clinical investigations, knowledge of the most common violations cited by the agency upon inspection is a useful tool for examining one’s own procedures and practices. It helps ensure they are not vulnerable to the same deficiencies before FDA arrives at your investigational site.

Pursuant to its Bioresearch Monitoring (“BIMO”) Program, FDA visits clinical research sites to conduct inspections of clinical investigations. The agency’s purpose in doing so is to determine if the clinical investigations are operating in compliance with applicable statutory and regulatory requirements governing the conduct of clinical trials. These on-site inspections are intended to document how the study is actually being conducted at the clinical site. Depending on the circumstances, these on-site inspections can be announced or unannounced for reasons such as verifying the accuracy and reliability of data that has been submitted to the agency, to follow-up on a complaint to FDA about the conduct of the study, to provide FDA with a real-time assessment of the investigator’s conduct of the trial and protection of human subjects, and in response to the concerns of the study’s sponsor, among others.

Such inspections often involve inspecting investigational records and interviewing individuals involved in the conduct of the study. Occasionally, the investigator also reviews the actual study data, potentially including case report forms, informed consent forms and medical records, e.g., progress notes, subject charts, and nurse’s notes. The FDA inspector’s observations are captured on a Form FDA-483 and can be used as the basis for a potential FDA enforcement action, if warranted.

A review of FDA’s cited observations for Fiscal Year 2012 indicates that investigators and sponsors are making avoidable mistakes that unnecessarily expose them to regulatory (and potentially criminal) sanctions. The most frequently cited observations include:

  1. Non-Compliance With the Protocol – The failure to comply with the study protocol was the most common type of observation involving clinical investigations in FY 2012. Often times, these types of violations occur when investigators do not adequately familiarize themselves with the investigational requirements or their own FDA regulatory obligations as investigators. In other instances, these violations occur when investigators intentionally deviate from the investigational requirements based on preliminary results without seeking the approvals necessary to do so. Simply put, investigators must understand and adhere to these requirements.
  2. Inadequate Case History Records – Investigators are required to prepare and maintain adequate and accurate case histories, recording all observations and other data pertinent to the study about each subject treated with the investigational article or enrolled as a control. It is especially important to have procedures in place to ensure that case history records are complete and up to date because they are often audited by FDA to verify the validity and completeness of the case report data submitted to the agency.
  3. Inadequate Investigational Article Accountability Records – The next most common observation involves an investigator’s failure to control and keep track of the investigational articles entrusted to his or her care for the purpose of conducting the study. It is important to establish and closely adhere to appropriate recordkeeping procedures for the receipt, use, and disposal/disposition of each study article.
  4. Inadequate Informed Consent Records – FDA continues to uncover problems with the adequacy of informed consent documentation prepared and maintained by investigators. Typical problems include use of consent forms that have not been approved by the IRB, forms that have not been signed by the subject (or their legally authorized representative), forms that were not properly dated when consent was given. In other instances, investigators fail to properly update consent forms and “re-consent” subjects when consent requirements change while the study is in progress.
  5. Sponsors’ Compliance with their General Responsibilities – This observation was used when, among other things, study sponsors failed: to meet their obligations to ensure that they have selected qualified investigators; to provide the selected investigators with the information that they need to conduct the investigation properly; to seek and receive IRB approval; to submit an IND/IDE application to FDA for a significant risk study; and to promptly inform FDA/IRB of significant new information about an investigation.  Sponsors must work hand-in-hand with FDA, the IRB, and investigators to assure compliance.

Investigators, sponsors, and IRBs would be well advised to re-examine their own policies and procedures for the conduct of clinical investigations to ensure that they are not vulnerable to these common deficiencies.

Competitive Foods Rule

By Roger R. Szemraj

On February 8, 2013, the Food and Nutrition Service (FNS) of the United States Department of Agriculture (USDA) issued a proposed rule entitled “Nutrition Standards for All Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010” (the proposed rule).  The proposed rule can be found here.  Public comments are invited for 60 days from the date of publication, with comments due April 9, 2013.


Section 208 (Sec. 208) of the Healthy, Hunger-Free Kids Act of 2010 (HHFKA) amends Section 10 of the Child Nutrition Act of 1966 (42 U.S.C. 1779) to require the Secretary of Agriculture (the Secretary) to develop science based nutrition standards for all foods sold ‘‘(i) outside the school meal programs; (ii) on the school campus; and (iii) at any time during the school day.”  As a result, the proposed rule establishes nutrition standards for all foods sold from the midnight before, to 30 minutes after the end of the official school day in vending machines, school stores, snack bars, and a la carte sales.   Sec. 208 further requires that this rule be consistent with the most recent Dietary Guidelines for Americans and that the Secretary shall consider authoritative scientific recommendations for nutrition standards; existing school nutrition standards, including voluntary standards for beverages and snack foods; current State and local standards; the practical application of the nutrition standards; and special exemptions for infrequent school-sponsored fundraisers other than fundraising through vending machines, school stores, snack bars, a la carte sales and any other exclusions determined by the Secretary.

It is projected that the proposed rule will impact 90,000 public schools, 6,000 private schools, and about 5,000 residential child care institutions that participate in the NSLP.[1]  About 95 percent of competitive food sales revenue accrues to school food authorities, while the remaining five percent go to other school groups, such as student clubs, parent teacher organizations, or parent booster organizations.[2]

These proposed standards for food and beverages are intended to be the minimum standards that local educational agencies, school food authorities and schools would be required to meet. State agencies and/or local schools are given the discretion to establish their own standards for non-program foods sold to children should they wish to do so, as long as such standards are consistent with the final minimum standards.  This discretion is intended to provide some measure of flexibility, given that many states and localities already have their own standards in place, some of which are already more stringent than those in the proposed rule.

The proposed rule does not include or exclude specific food items.  Rather, it proposes standards, with a limited number of exceptions, for foods and beverages based on fat, saturated fat, sugar, and sodium content much like those in use as part of the NSLP and the School Breakfast Program (SBP).  There are caloric limitations on portion sizes, with limited variation for different grade levels.  Portions of the Food and Beverage Requirements follow [3]:

“Food Requirements – Under the proposed rule, any food sold in schools must:

  1. Be either a fruit, a vegetable, a dairy product, a protein food, a “whole-grain rich” grain  product (50% or more whole grains by weight or have whole grains as the first ingredient), or a combination food that contains at least ¼ cup of fruit or vegetable; or
  2. Contain 10% of the Daily Value (DV) of a nutrient cited as a public health concern in the 2010 Dietary Guidelines for Americans (DGA) (calcium, potassium, vitamin D, or fiber).

Additionally, foods sold must meet a range of calorie and nutrient requirements:

  • Total fat must be ≤35% of calories; saturated fat must be <10% of calories; and trans fat must be 0g as stated on the label. Exemptions are provided for reduced fat cheese; nuts and nut butters without other ingredients and seafood with no added fat.
  • Snack items shall contain ≤200 milligrams of sodium. For entrée items, sodium levels must be ≤480 milligrams per portion, for non-NSLP/SBP entrée items.
  • For total sugar levels the proposal includes two alternatives: one is ≤35% of calories and the other is ≤35% of weight. Exemptions are provided for fruits and vegetables packed in juice or extra-light syrup and for certain yogurts.
  • Snack items have a limit on calories of ≤200 calories per portion. Non- NSLP/SBP entrée items have a calorie limit of ≤350 calories.

Beverage Requirements – Under the proposal, all schools may sell plain water, plain low fat milk, plain or flavored fat-free milk and milk alternatives permitted by NSLP/SBP, and 100% fruit/vegetable juice. Portion sizes of milk and juice vary by the age of students.  Elementary schools may sell up to 8-ounce portions. Middle schools and high schools may sell up to 12-ounce portions.

Beyond this, the proposal offers additional beverage options in high schools. These include 20 ounce servings or less for calorie-free, flavored and/or unflavored carbonated water and other calorie-free beverages that comply with the Food and Drug Administration (FDA) standard of <5 cals/serving.

Additionally, the proposal would allow 12 ounce servings of other beverages within a specified calorie limit. The proposal offers two alternatives for this limit. The first is ≤ 40 cals/8 oz serving (or ≤ 60 cals/12 oz serving), and the second is 50 cals/8 oz serving (or 75 cals/12 oz serving).

Such beverages shall not be available in the meal service area during the meal service periods.”

The proposed rule also allows exceptions for foods sold as part of infrequent fundraising activities.  All foods that meet the proposed standards could be sold during fundraisers during school hours.  The proposed standards would not apply to items sold during non-school hours, weekends or off-campus fundraising events, such as concessions during sporting events and school plays.

The Secretary is also required, in the future, to review and update as necessary the school nutrition standards and requirements as soon as practicable after the publication of a new edition of the Dietary Guidelines for Americans.

The proposed rule does not provide any requirements for the posting of nutrient information for competitive foods.

FNS has issued a brief Question and Answer document regarding the proposed rule, which can be found here.  This document does explicitly state that USDA has no role in regulating foods brought from home, and birthday treats are not subject to the standards.

[1] Click here for more information about the HealthierUS School Challenge Program.

[2] 78 Fed. Reg. 9548 (February 8, 2013).

[3] Id.

Federal Budget Process Outline and Outlook

By Roger R. Szemraj

Congress did not complete three significant budget matters in 2012: an alternative to sequestration, full federal fiscal year appropriations legislation, and a budget resolution. Each of these items is interrelated, and expected to be taken up over the course of the next several months. They are likely to have significant implications for the FY 2014 federal funding process, and will potentially establish spending limitations and priorities for years to come.  This memorandum is intended to provide an outline for what to expect in these coming months, and, based upon statements made by House and Senate leaders, what the outlook for this process might be.

Chicken Farmer, American Farm Bureau Don’t Want to Let EPA Off the Hook

By John G. Dillard

There have been new developments in the Alt v. EPA case (AgFDABlog first reported on this case in October).

EPA bit off more than it could chew when it went after Lois Alt – a West Virginia chicken farmer who is not afraid of a fight. Now, facing a lawsuit from Alt and opposition from the American Farm Bureau Federation and West Virginia Farm Bureau, EPA is attempting to back down from the fight. However, Alt and the Farm Bureaus do not want to let EPA off so easily.

Read the rest of this post on John Dillard’s Blog – Ag in the Courtroom.