Dietary Supplement Advertising

Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below:

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State AGs and the New Administration
By John Villafranco and Katie Bond

As we discussed in recent interviews with Nutritional Outlook and Natural Products Insider, FTC enforcement against supplement companies is likely to evolve into something much more reasonable under the new administration.  State attorney general activity, however, is likely to become more aggressive – or at least more widespread.  State regulators may perceive a need to fill in gaps or may see an opportunity for revenue that will be missed by federal regulators.

States to keep an eye on in coming months include Indiana, Oregon, Missouri, Hawaii, Tennessee, Maine, and as discussed more below, Iowa.  These states have either become more active in supplement cases recently or have expressed an interest in increased regulation of the industry.  New York and California have been, and remain, active in enforcement against dietary supplement companies.

As part of our Ad Law group’s new webinar series, we’ll be hosting a discussion focused on state regulation and enforcement on April 26, 2017.  Also, on May 3, 2017, Kelley Drye will host an event focused on the first 100 days of the Trump Administration.  A panel session will include state attorneys general who will provide regulatory updates and insights on enforcement.

Iowa: The New New York or California?
By Katie Bond

Regulators in New York and California have been a perennial concern for dietary supplement makers for years.  Iowa now appears to be angling to join them.  The following summarizes activities of the Iowa AG’s office over the last two years.

  • The Iowa AG’s office was involved in the 2015 investigations into numerous store-brand botanical products.  Based on testing that was widely known to be faulty, regulators led by the New York AG, alleged that products lacked the botanical ingredients that they were labeled as containing.
  • Also in 2015, the Iowa AG joined 13 other state AGs in sending a letter to Congressional leaders urging them “to launch a comprehensive congressional inquiry into the herbal supplements industry, and to weigh a more robust oversight role for the Food and Drug Administration.”
  • In September 2016, the Iowa AG’s office announced a $30,000 settlement with an Australian company over bladder control claims for its dietary supplements.
  • The same month, the Iowa AG’s office announced a $100,000 settlement with Walmart over the following statement on its store brand supplements: “Verified by an independent, certified laboratory.”  The AG’s office contended that the statement exaggerated the level of testing backing the products.  Walmart vehemently disputed the allegations and noted that the AG’s office had received no complaints about the statement.  Walmart agreed to remove the statement in order to settle the case.
  • Also in September 2016, the Iowa AG’s office reached a settlement with a dietary supplement company that allegedly violated a 2014 order entered in Iowa.  The earlier order banned the company from telemarketing in the state.  According to the AG’s office, the company teamed up with a third party company to attempt to complete telemarketing sales in Iowa despite the order.

A consumer newsletter published by the Iowa AG’s office last year focused on dietary supplements and suggested a skeptical view of the industry overall.  One passage stated as follows:
Although supplement marketers often promote their products a[s] vital to good health, supplements shouldn’t replace a healthy, balanced diet. You may not need supplements if you maintain a good and varied diet, and too much of some nutrients (such as through vitamins) can cause problems. On the other hand, there are people who will benefit from some types of supplements — such as pregnant women who take folic acid.

But, as largely unregulated products, supplements may contain ingredients not listed on the product label; contain ingredients at higher or lower amounts than listed (or not even contain a listed ingredient); could be manufactured inconsistently; sellers may make false, misleading or unsupported “miracle cure” health claims; and some products may lead to serious health effects or even death. Unlike with drugs, supplement manufacturers are not allowed to promote their products to treat, diagnose, prevent, or cure diseases.


Class Actions over St. John’s Wort Still Flowing from Consumer Labs Testing
By Katie Bond

Two retailers recently faced class action complaints over the ingredient content of store-brand St. John’s Wort products.  Plaintiffs allege that products provide less of the active component, hypericin, than labels indicate.  A similar class action naming several manufacturers is currently being litigated in Illinois.

These class actions followed an announcement by Consumer Labs last year that it had commissioned testing of ten St. John’s Wort products and found that some contained less than the declared amounts of standardized actives.  Consumer Labs offered access to its testing reports to those who agreed to pay a one or two-year membership fee (advertised costs: $39 for one year, $64 for two).  Consumer Labs noted that “[a]ll supplements were further tested for potential contamination with the heavy metals arsenic, cadmium, and lead.”

Trends in Consumer Class Actions

The following are areas where dietary supplement makers continue to face class actions:

  • Slack fill;
  • Purported “protein spiking”;
  • Joint claims based on glucosamine and chondroitin;
  • Weight loss claims; and
  • “Made in the USA” claims.

Kelley Drye partners Jeff Jacobson and August Horvath recently hosted a webinar, “Litigation is Inevitable.”  They provided an update on class action trends across a range of industries and provided guidance and strategies on how to knock out cases.  A recording of the webinar is available here. 

Partner Kristi Wolff co-authored the Nutritional Outlook article “Suing over Empty Space: Why Lawsuits over Slack Fill in Packaging Are Growing.”


FTC Business Guide on CRFA
By John Villafranco and Katie Bond

The FTC recently issued a business guide on the Consumer Review Fairness Act (“CRFA”).  The CRFA, which was enacted in late 2016, prohibits businesses from including in form contracts any provisions that would restrict the ability of consumers to provide reviews about the goods or services they purchased.

The new business guide provides a brief overview of the law without adding much else.  The guide notes that an example of a CRFA violation would be a company that provides a product or service online and includes a provision “in its terms and conditions that prohibits or punishes negative reviews by customers.”

The new business guide also describes exceptions in CRFA that allow reviews to be prohibited if they contain (1) certain confidential or private information, (2) libelous or discriminatory content, (3) information unrelated to the business’s products or services, or (4) clearly false or misleading information.  The guide notes that “it’s unlikely that a consumer’s assessment or opinion with which [a company] disagree[s] meets the ‘clearly false or misleading’ standard.”

The CRFA enables both the FTC and state regulators to bring actions for violations.  The FTC may seek civil penalties under existing provisions in the FTC Act or it may seek redress through its administrative court or federal court.  States are enabled to “bring a civil action” for any violation.  Presumably, states would allege that contracts that violate the CRFA also violate their state consumer laws, which provide mechanisms for monetary and injunctive relief.

To be sure, the FTC hasn’t waited for the CRFA to begin enforcement over contract terms that restrict reviews.  In 2015, the FTC filed a lawsuit against a seller of weight loss products that had provided online terms and a package insert restricting negative reviews.  According to the FTC, the package insert stated that each product had been provided at the discount price of $480, and that any negative review would cause the remainder of the full price of $1580 to become due.  The company allegedly threatened to enforce the provision and sued some consumers who posted bad reviews.  The FTC contends in its case that the company’s practices were unfair in violation of the FTC Act.  Litigation is ongoing, and in September, the FTC obtained an asset freeze against the company.

The FTC: Taking Enforcement to Canada?
By Katie Bond

The FTC and Maine recently announced settlements with several related companies and individuals over marketing practices used to sell a joint supplement and a cognitive function supplement.  The complaint and settlement orders in the case may be helpful reading for companies using expert endorsers, telemarketing, free trials, or negative option programs.  However, what struck us as the most interesting aspect of this case was its reach outside U.S. borders.

It isn’t unusual for the FTC to take enforcement action against foreign companies marketing dietary supplements or other products in the United States.  The complaints, however, will describe only the U.S. practices, and only U.S. sales.  For instance, a couple of years ago the FTC took action against a Canadian company that sold a weight loss product in the United States.  The FTC’s complaint carefully noted that the company was located in Canada but had “labeled, advertised, marketed, distributed, or sold [the product] to consumers throughout the United States.”  The complaint also identified only “net sales of [the product] in the United States.”

In the recent case by the FTC and Maine, the allegations veer north.  In describing each corporate defendant, the complaint notes that each advertised or sold products “in this District [meaning Maine], throughout the United States and Canada.”  The complaint likewise alleges that the defendants, all together, sold products “directly to consumers, primarily through radio and print advertising nationwide and in Canada, which has garnered in excess of $6.5 million in gross sales from January 1, 2012 through April 30, 2015.”  A resulting settlement order includes monetary relief in the amount of $6,574,957, which appears to capture both the alleged U.S. and Canadian sales.

It’s difficult to know what led to this settlement reaching sales and marketing practices in another country.  But, one message is clear: there is strategy involved in every step of an investigation and negotiation with the FTC, and every effort must be made to confine an investigation solely to FTC jurisdiction.  Foreign advertising and sales are irrelevant to U.S. business practices and are outside of FTC jurisdiction.


John Villafranco
Washington, DC
(202) 342-8423
Sarah Roller
Washington, DC
(202) 342-8582
Kristi Wolff
Washington, DC
(202) 342-8805
Katie Bond
Senior Associate
Washington, DC
(202) 342-8537

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists.  Responding to questions from the audience, Dr. Mayne was asked to comment on how the Trump administration’s emphasis on deregulation is likely to impact CFSAN’s work.  Speaking generally, Dr. Mayne indicated that there may be opportunities for minor adjustments or tweaks, but stated that she does not anticipate broad rollbacks of the work on which CFSAN has been focused in recent years, largely because the efforts are supported by key stakeholders and implementation is ongoing.  She offered a few examples to support her rationale, including the following:

  • FSMA Rules:  Dr. Mayne noted that FSMA had bipartisan support in Congress along with industry support.  Moreover, given that the agency has finalized seven FSMA rules and implementation is well underway, there may be instances in which specific challenges could be addressed through narrow modifications but broader changes are not anticipated.  As an example of challenges where tweaks may be a possibility, she stated that the agricultural water standards pose unique considerations and could be an area of flexibility.
  • Menu Labeling:  Similar to FSMA, the menu labeling requirements enacted via § 4205 of the Affordable Care Act (ACA) were supported by the restaurant industry and many restaurant chains have already undertaken implementation.  Further, absent national standards, it is foreseeable that states and municipalities could set their own menu labeling requirements – potentially resulting in a state and local patchwork that creates its own compliance challenges.  Although repealing ACA has been the topic of much discussion, she noted that menu labeling is not funded as part of the same budget process and new legislation would be required to repeal it.
  • Nutrition Facts:  Changes to the nutrition facts labels went through multi-year notice and comment and are already being implemented.  Dr. Mayne stated that the agency continues to work through how changes to the nutrition facts labels impact nutrient content and health claims, an issue that she indicated they anticipated.

Dr. Mayne did not comment on the President’s executive order requiring that two regulations be eliminated for every new regulation issued or related cost offset provisions.

Placing Food on the EU Market? Prepare for Potential Regulatory Rollercoaster

In the world of food, 2017 promises to be a busy year across the European Union for regulators and regulated alike.  To the great disappointment of gourmands, farmers and producers, French foie gras exports remain blocked due to spread of avian influenza to wild ducks in France and detection of the H5N8 virus at a French duck farm last week.  At risk are the venerated “frites”, recognized as cultural heritage by UNESCO, which, among other popular foods, are fried or baked at high temperatures that may cause the formation of acrylamide, a toxic substance.  Non-governmental organisations are calling for tougher regulatory controls, which industry fears might affect taste, among other things, and the Commission has been waffling in all directions.  

Confrontations between health advocates, industry groups and national regulators also are running rampant on everything from possible taxes based on sugar content, to “traffic light” food labeling for consumers, to whether foods with pesticide residues may be labeled as “organic.”  Meanwhile, the European Commission is asking the 28 Member States to report on tetrahydrocannabinol in foods that may be present due to the use of hemp as animal feed to facilitate a safety assessment for human consumption of meat and eggs.

The European Parliament has proposed a slate of regulatory actions on food contact materials, including additional safety requirements and expanded risk assessment (see related advisory on Food Contact Materials).  Add to that calls from one of the world’s largest food producers for the Commission to adopt a unified and transparent approach to health and nutritional claims and food labelling to cut inhibiting complexity and bureaucracy and your regulatory plate already will be overflowing.  But that’s not all: the World Health Organisation’s push for implementation of binding rules and imposition of financial sanctions on companies that fail to protect persons under 16 of age when advertising foods high in saturated fats, sugar or salt is sure to have results.  Put on your seatbelts. 

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.”  Today, it announced the beginning of the formal process to make changes to the definition of the term.  The agency opened a new docket and is publishing a Request for Information and Comments relating to use of the term “healthy” in the labeling of human food products.  It also issued a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

Under current regulations, “healthy” can only be used as an implied a nutrient content claim when a food product meets certain nutritional criteria. For instance, most individual food products marketed as “healthy” must be low in fat and saturated fat, must have no more than 480 mg of sodium or the disclosure level for cholesterol, and must contain at least 10 percent Daily Value of one of the following nutrients:  vitamin A, vitamin C, calcium, iron, protein, or fiber.

Companies and experts have noted that this conception of “healthy” is inconsistent with current nutritional guidance, including the 2015-2020 Dietary Guidelines for Americans.  Stakeholders have also asked for clarification on claims that a product can be a part of a healthy diet or is useful in maintaining healthy dietary practices.  In particular, a citizen petition from KIND LLC argues that the current FDA policy “limits the ability of food producers to tell consumers that products containing certain foods – such as nuts, whole grains, seafood, fruits, and vegetables – are healthy, even though they are currently recommended as key components of a healthful diet.”

The Request for Information and Comments also highlights the following questions:

  • Is the term “healthy” most appropriately categorized as a claim based only on nutrient content? If not, what other criteria (e.g., inclusion of foods from specific food categories) would be appropriate to consider in defining the term “healthy” for use in food labeling?
  • If criteria other than nutrient content (e. g., amount of whole grain) are to be included in the definition of the term “healthy,” how might FDA determine whether foods labeled “healthy” comply with such other criteria for bearing the claim?
  • What types of food, if any, should be allowed to bear the term ‘‘healthy?” Should all food categories be subject to the same criteria?
  • Is “healthy” the best term to characterize foods that should be encouraged to build healthy dietary practices or patterns? What other words or terms might be more appropriate (e.g., “nutritious”)? FDA encourages submission of any studies or data related to descriptors used to communicate the overall healthfulness of a food product.
  • What nutrient criteria should be considered for the definition of the term “healthy?”
  • Should nutrients for which intake is recommended to be limited be included? Should nutrients for which intake is encouraged continue to be included?
  • If nutrients for which intake is encouraged are included in the definition, should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population, or should they include those nutrients that contribute to general overall health? Should the nutrients be intrinsic to the foods, or could they be provided in part – or in total – via fortification?
  • Are there current dietary recommendations (e.g., the Dietary Guidelines for Americans) or nutrient intake requirements, such as those described in the final rule updating the Nutrition Facts label or those provided by the Institute of Medicine (IOM) in the form of Dietary Reference Intakes (DRI) that should be reflected in criteria for use of the term “healthy?”
  • What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling?
  • What is consumers’ understanding of the meaning of the term “healthy” as it relates to food? What are consumers’ expectations of foods that carry a “healthy” claim? FDA is especially interested in any data or other information that evaluates whether or not consumers associate, confuse, or compare the term “healthy” with other descriptive terms and claims.
  • Would this change in the term “healthy” cause a shift in consumer behavior in terms of dietary choices? For example, would it cause a shift away from purchasing or consuming fruits and vegetables that do not contain a “healthy” claim and towards purchasing or consuming processed foods that bear this new “healthy” claim?
  • How will the food industry and consumers regard a change in the definition of “healthy?”
  • What would be the costs to industry of the change?

Comments will be due within 120 days of publication of the Request in the Federal Register.

In the meantime, FDA released a guidance document explaining a new policy of enforcement discretion for certain products labeled as “healthy.” In particular, the guidance advises food manufacturers of FDA’s intent to exercise enforcement discretion (i.e., not enforce all elements of the current “healthy” definition) for two new categories of foods:

  • Foods that have a fat profile of predominantly mono- and polyunsaturated fats, but do not meet the regulatory definition of “low fat;” and
  • Foods that contain at least 10 percent of the Daily Value of potassium or vitamin D, rather than vitamin A, vitamin C, calcium, iron, protein, or fiber.

Either type of food should meet the other conditions of a “healthy” claim as set forth in the regulatory definition. FDA will accept public comments on this guidance at any time.

We will be closely monitoring the comments on the use of the term “healthy” and any related FDA action on this significant regulatory change.

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research.  This move is expected to expand and diversify the supply of marijuana for research use.  Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the National Institute on Drug Abuse (NIDA).  The process for getting access to University of Mississippi marijuana for research through NIDA has been criticized as overly restrictive and slow.   Under the new policy, additional entities may apply to register with DEA; once registered, they would be able to grow and distribute marijuana for FDA-authorized research purposes.

The DEA also released responses to two pending petitions asking the agency to reschedule marijuana.  The petitions had been filed by Bryan Krumm in 2009 and by former Washington Governor Christie Gregoire and former Rhode Island Governor Lincoln Chafee in 2011.  In a letter responding to the petitions, DEA Acting Administrator Chuck Rosenberg explained that Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous.  Rather than being a reflection of relative danger, Schedule I classification is used in the substance has no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.  According to Rosenberg, marijuana currently meets that criteria.

Despite the decision not to reschedule marijuana, DEA clearly expressed support for marijuana research, performed in compliance with the existing rules.  Rosenberg stated that DEA has never denied an application from a researcher to use lawfully produced marijuana in a study determined by the Department of Health and Human Services (HHS) to be scientifically meritorious.  During the last two plus years, the total number of individuals and institutions registered with DEA to research marijuana, marijuana extracts, derivatives, and tetrahydrocannabinols (THC) has more than doubled, from 161 in April 2014 to 354 at present.  According to Rosenberg, NIDA is filling requests for research marijuana in an average of 25 days.  If, based on this research, “the scientific understanding about marijuana changes – and it could change – then the decision [on scheduling] could change,” Rosenberg said.

In December 2015, DEA waived certain regulatory requirements for researchers conducting FDA-authorized clinical trials on cannabidiol (CBD), a constituent part of marijuana that has shown promise in treating a variety of ailments, including seizure disorders.  Earlier, in June 2015, HHS eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana.

To further ease the process for researchers, DEA is building an online application system to apply for Schedule 1 research registrations, including for marijuana.  It also is drafting guidance to assist Schedule I researchers in that application process.  We will continue to monitor the actions of DEA, FDA, and the states with regard to research requirements, pending clinical trials, and steps toward legalization.

Congress Passes National GMO Disclosure Law

On Thursday the U.S. House of Representatives passed S. 764, a Senate-initiated bill establishing a national uniform standard for labeling of bioengineered foods, sometimes referred to as genetically modified foods or GMOs. The law will prevent a patchwork of state standards by preempting inconsistent state laws such as Vermont’s controversial labeling rule, which took effect on July 1 of this year.  President Obama is expected to sign the bill into law shortly.

The bill provides for a national uniform standard for the disclosure of bioengineered foods. Recognizing that label space is limited, in addition to allowing disclosure in text or a symbol on the label, the bill would alternatively allow disclosure through a digital link to a website (i.e., QR code or similar technology). This policy, as we previously wrote, was the result of a compromise between Senate Agriculture Committee Chairman Sen. Pat Roberts and Committee Ranking Member Sen. Debbie Stabenow, and the bill passed both houses with bi-partisan support.

The bill establishes some general contours for the disclosure rules, such as a policy that meat will not be considered bioengineered solely because the animal consumed bioengineered feed, and a carve out for foods served at restaurants. However, specific standards will be set by the Department of Agriculture, which is required to issue implementing regulations within two years of the law’s passage.  We will be closely monitoring those developments.

Senators Reach Compromise on GMO Labeling Bill

Yesterday, U.S. Senate Agriculture Committee Chairman Pat Roberts, R-Kan., and Ranking Member Debbie Stabenow, D-Mich., announced a bipartisan compromise bill regarding labeling of bioengineered foods, sometimes referred to as “genetically modified organisms” or “GMOs.”  They stated, “This bipartisan agreement is an important path forward that represents a true compromise. Since time is of the essence, we urge our colleagues to move swiftly to support this bill.”

The bill provides for a national uniform labeling standard for the disclosure of bioengineered foods. Recognizing that label space is limited, in addition to allowing disclosure in text or a symbol on the label, the bill would alternatively allow disclosure through a digital link to a website (i.e., QR code or similar technology).

With regard to voluntary labeling, the agreement expressly allows products that do not contain bioengineered ingredients – such as organic foods – to be labeled “non-GMO.”

The law, if passed, would prevent a patchwork of state standards by preempting inconsistent state laws such as Vermont’s controversial labeling rule.

Before being signed into law, the bill needs to be approved by the Agriculture Committee, the full Senate, and the House.

We have previously written about FDA’s position on voluntary GMO-related claims here.

Philadelphia Targets Sweetened Beverages for New Revenue; Imposes First Big-City Soda Tax

On Thursday Philadelphia became the first major U.S. city to approve a tax on sodas and other sweetened beverages.  In enacting Bill Number 16017601, the Council added a new Chapter 19-4100 to the city code, which imposes a $0.015 per fluid ounce tax on beverages and beverage concentrates sweetened with sugar-based sweeteners or artificial sugar substitutes such as stevia, saccharin, or aspartame.   The tax is expected to add 18 cents to the cost of a can of soda.

The provision does not apply to infant formula, medical foods, products that are more than 50 percent milk, products that are more than 50 percent fresh fruit, vegetables or a combination of the two, unsweetened drinks to which a purchaser can add or request the addition of sugar, or syrups or other concentrates that the customer can combines with other ingredients to create a beverage.

Examples of sugar-sweetened beverages include, soda, fruit drinks without the minimum amount of fruit, sports drinks, sweetened flavored water, energy drinks, presweetened coffee or tea, and non-alcoholic beverages intended to be mixed into an alcoholic drink.

Under the new section, retailers and restaurants selling “sugar-sweetened beverages” – a term that includes beverages sweetened with artificial sweeteners rather than sugar – must purchase the beverages from distributors who are registered with the city.  In addition, such retailers must notify the registered distributor that the retailer is a dealer under the law and that the purchase is subject to the tax. Then, the registered distributor must provide confirmation to the retailer of the notice and provide a receipt detailing the amount of beverage purchased and the applicable amount of tax.  The tax is paid to the city by the registered distributor, not by the retailer.   However, if a retailer fails to provide notice to the registered distributor, it will be liable for the tax.

Under an original proposal, Philadelphia Mayor Jim Kenney sought a three-cent-per-ounce tax to fund various desired programs.  A compromise resulted in the 1.5-cent-per-ounce tax, which is projected to raise $409.5 million over five years to support expanded pre-K, community projects, and other city expenses.

Several U.S. cities, including Boulder and San Francisco, are considering their own taxes on sweetened beverages. In addition, many states and cities already have carve-outs from their sales tax exemptions, providing that unlike other foods, sweetened beverages remain subject to sales tax. And in 2014, Berkeley, California became the first U.S. city to adopt a sweetened beverage tax, charging a penny-per-ounce.  Readers will also recall that New York City’s effort to ban large soft drinks was struck down by a state court in 2013, on the grounds that the state health board did not have the authority to impose the ban.

The news of the new tax comes on the heels of FDA’s long-awaited and much-discussed final rule on nutrition labeling, which mandates the disclosure of added sugar on packaged food nutrition labels.  In addition, FDA has hinted that it will look to redefine the conditions under which a product can be called “healthy,” and some public health advocates have suggested that the revision should include a limit on sugar or added sugars.

FDA Releases Final Rules Revising Nutrition Facts Label and Certain Serving Sizes; Industry Given Two to Three Years to Comply

FDA announced today that it was finalizing two previously proposed rules that will require industry to overhaul Nutrition Facts panels on all food products sold in the United States and recalculate serving sizes for some foods.  The new rules mark the first time that FDA has engaged in rulemaking to update the framework for nutrition labeling since 1993 and include revisions to the general format and display, the nutrients that must be displayed, and the serving sizes used to calculate nutrient information.  The final rules are largely consistent with the initial proposed rules, which we covered here and here.  Notable changes from today’s labels include:

  • A revamped format, as shown in the imageFOP Label to the left provided by FDA, which will increase the type size for “Calories,” “servings per container,” and the “Serving Size declaration.”
  • The addition of “added sugars” in grams and as a percent Daily Value.  Controversially, FDA issued a supplemental rule in July 2015 to the initially proposed rules in March 2014, which proposed to include a percent daily value for added sugars that would not exceed 10 percent of total calories.  In finalizing the rule as proposed, FDA rejected comments noting that it has acknowledged that there is no chemical difference between sugars that are added to foods and naturally occurring sugars, and cited data that allegedly shows that it is difficult to meet nutrient needs if you consume more than 10 percent of your total daily calories from added sugar.
  • The addition of Vitamin D and Potassium as mandatory declarations.  Citing food consumption surveys by the CDC, FDA will require vitamin D and potassium to be added to the Nutrition Facts label based on perceived deficiencies in the American population.  Vitamins A and C will no longer be mandatory declarations, although manufacturers can still list these vitamins voluntarily.
  • Revisions to serving sizes.  The final rule revises serving sizes based on more recent food consumption data.  For example, the serving size for ice cream is changing from 1/2 cup and 2/3 cup and the serving size of soda is changing from 8 ounces to 12 ounces.
  • New requirements for multi-serving packages.  Dual column labeling that shows information both per serving and per container will be required for certain food packages that can be consumed in one sitting or multiple sittings.  For packages between one and two servings, calories and other nutrients must be declared for the entire package rather than per serving.  In justifying the revised approach circumscribing manufacturers’ labeling choices for multi-serving packages, FDA pointed to the likelihood that a typical consumer will consume a particular product in one sitting.
  • New definition for dietary fiber.  The final rule adopts a new definition for dietary fiber that requires FDA to have made a determination that the substance has physiological effects that are beneficial to human health.  The new definition will present a host of legal and logistical issues for manufacturers as they determine how to calculate a particular product’s dietary fiber content.
  • New recordkeeping requirements.  The rules also impose onerous new recordkeeping requirements on manufacturers, which will require manufacturers to make and keep records related to added sugars, certain fibers, vitamin E, folic acid, and folate.

As far as when consumers can expect to start seeing the new labels in stores, it’s not entirely clear.  Most companies will have to comply within two years, while small businesses (defined as having less than $10 million in annual sales) will have three years.  But at this stage, it’s unclear whether compliance means that all labels with the old format must be off store shelves, or whether only newly manufactured products will need to use the new labels.

The final rules are set to be published in the Federal Register next week.  FDA will likely continue to issue guidances and other documents designed to help businesses and consumers prepare for implementation of the new regulations.  Stay tuned for what is bound to be an interesting process as the industry overhauls labels for the first time in over 20 years.

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously released rules governing current good manufacturing practice, hazard analysis and risk-based preventive controls for human food and animal food (“the Preventive Controls Rules”).  Under FSMA and the Preventive Controls Rules, a “qualified facility” is not generally subject to hazard analysis and risk-based preventive controls and supply-chain requirements imposed under the Preventive Controls Rules.  However, a qualified facility must submit an attestation that the facility meets the definition of a qualified facility and that the facility has identified potential hazards, implemented preventive controls to control those hazards, and is monitoring the effectiveness of those controls.  The draft guidance provides more information about how a facility can determine whether it is indeed a “qualified facility” and how it should submit the required attestation.

While a facility can meet the “qualified facility” definition in two ways, the draft guidance indicates that FDA “believe[s] the definition of a very small business will apply to most qualified facilities” and thus focuses on determining whether a facility will meet that definition.  Under the Preventive Controls for Human Food Rule, a “very small business” is a business, including any subsidiaries and affiliates, averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).   The Preventive Controls for Animal Food Rule defines “very small business” similarly, except that the relevant figure is $2,500,000.

In addition to summarizing the relevant provisions of the Preventive Controls Rules, the draft guidance offers new insight into how facilities should evaluate whether they meet the relevant definition.  Notably, the draft guidance explains:

  • The total annual sales criteria applies equally to all affiliated entities, regardless of whether the entity is the parent, subsidiary or affiliate, such that either all or none of related entities will constitute a qualified facility.
  • Facilities must include all human or animal food, depending on the rule, when determining sales and market value.  This means that the facility must include in its calculations both: (1) food that is not subject to the Preventive Controls Rules (e.g., seafood, juice, low-acid canned foods, and dietary supplements); and (2) raw agricultural commodities and products subject to regulation by USDA.
  • In determining annual sales, facilities should look to preexisting resources such as tax forms, accounting documents, invoices, and bills of lading.
  • In determining the market value of food manufactured, processed, packed or held without sale, facilities should consider factors such as the cost of the incoming food, the amount of insurance that a warehouse holds for its products, and assets on a balance sheet.

The draft guidance also provides examples of calculations and responds to potential questions about specific situations.  Human food facilities are required to submit their first attestation to FDA by December 17, 2018, while animal food facilities are required to submit their first attestation by December 16, 2019.  While stakeholders can always submit comments on guidance documents, FDA encourages comments to be submitted by November 14, 2016 in order to ensure consideration before it begins work on the final version of the guidance.