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.

FDA Finalizes Additional Guidance on Medical Foods; Continues to Take Narrow View of Category


FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act.

Although most of the content of the final guidance mirrors the draft guidance released in August 2013, the final guidance clarifies the following points:

  • Medical foods are exempt from the labeling requirements for nutrient content claims and for health claims under the Nutrition Labeling and Education Act of 1990. However, if they bear false or misleading claims they will be considered misbranded under section 403(a)(1) of the Food, Drug, and Cosmetic Act.
  • FDA does not maintain a comprehensive list of medical food products. This question and answer was not included in the draft guidance.
  • There are no distinctive nutritional requirements associated with pregnancy. This is a departure from the conclusions in the draft guidance.
  • There are no distinctive nutritional requirements associated with the management of diabetes mellitus. This, too, is a departure from the conclusions in the draft guidance.

Medical foods must be formulated to be consumed or administered enterally under the supervision of a physician and are used for specific dietary management of a disease or condition with distinctive nutritional requirements. 21 U.S.C. 360ee(b)(3).  FDA’s reading of this definition has been criticized as being unduly restrictive.  For instance, FDA’s interpretation excludes products directed towards diseases or conditions that can also be addressed through modification of the diet, a limitation not included in the statutory definition. See 21 CFR 101.9(j)(8).  The final guidance does not broaden FDA’s interpretation of the medical foods category.

Under FDA’s interpretation, medical foods can be used to manage inborn errors of metabolism such as phenylketonuria, which impairs metabolism of the amino acid phenylalanine. However, the guidance advises that pregnancy, diabetes mellitus, and diseases resulting from essential nutrient deficiencies are not diseases or conditions with distinctive nutritional requirements, and thus FDA generally does not see products intended to manage those conditions as medical foods.

Aside from providing guidance on the scope of the medical foods category, the FAQs offer practical advice for manufacturers and retailers of medical foods. For instance, although medical foods should be formulated to be used “under the supervision of a physician,” which means that the patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food.  A product can be labeled accordingly.  However, the guidance makes clear that medical foods should not be labeled as “Rx only,” as that designation would be false and misleading. In addition, the guidance is clear that the labeling of medical foods should not include National Drug Code (NDC) numbers, the unique numbers assigned to each listed drug that identifies the labeler, product, and trade package size.  NDC numbers are often used by retailers to track sales of products, but FDA’s view is that NDC numbers should only be used on drugs.  According to FDA, using NDC numbers on medical foods could convey a false message that FDA has approved the medical food.

Understanding your product’s category under FDA’s regulatory regime – whether conventional food, dietary supplement, medical food, or drug – is essential for complying with FDA requirements for registration, labeling, and promotion of the product. This final guidance reiterates FDA’s position that the medical food category is narrow.  Companies marketing a product as a medical food should carefully consider FDA’s reading of the term “medical food” and ensure that their labeling and promotion of the product is consistent with FDA rules.


FDA to Chew Over Meaning of “Healthy”

appleAlthough “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat.  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it will be re-considering the criteria for “healthy” and similar claims.

In March 2015, KIND, the makers of granola bars, received a warning letter from FDA in part because it labeled certain products as “healthy” even though the products contained more saturated fat than is permitted for a “healthy” claim.  KIND changed its labeling, and FDA issued a closeout letter in April 2016.   Soon after, KIND requested that FDA confirm it could use “healthy” to describe the company’s corporate philosophy.  FDA agreed that using “healthy” in that way is acceptable, because it is not used as a nutrient content claim and does not appear on the same display panel as nutrient content claims or nutrition information.

FDA issued a statement explaining its analysis of the “healthy” claim for KIND’s corporate philosophy and in that statement, it also announced that “now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.’” FDA cited evolving nutrition research, forthcoming Nutrition Facts labeling final rules, and a citizen petition from KIND for this decision.

FDA plans to solicit public comments on these issues “in the near future.” Through the comment process, companies and organizations with views on the appropriate criteria for “healthy” and other nutrient content claims can help educate FDA and ultimately shape FDA policy.  Stakeholders should begin considering their opinions now, to be able to respond when FDA opens its comment period.

FDA Final Rule for Foods and Cosmetics Aims to Reduce Risk of Mad Cow Exposure

Today the FDA issued its final rule prohibiting the use of certain cattle material in human foods, dietary supplements, and cosmetics.  The rule is focused on reducing the risk of human exposure to bovine spongiform encephalopathy (BSE), a fatal neurological disorder sometimes known as “mad cow disease.”  The rule will take effect on April 18, 2016.

Under the final rule, FDA prohibits the use of designated parts and organs referred to as “specified risk materials.” Studies have shown that when cattle are infected with BSE, the BSE agent resides in these parts and organs.  The final rule also prohibits the use of the small intestine (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption by the appropriate regulatory authority, and mechanically separated beef.  FDA has clarified that other materials can be used in foods and cosmetics and are not prohibited: milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and gelatin manufactured using customary industry practices.

Cattle materials inspected and passed from a country specifically designated under the rule are also carved out from the BSE-related restrictions. A country seeking to be designated must send a written request to the Director of FDA’s Center for Food Safety and Applied Nutrition, including information about the country’s BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.

The final rule completes a rulemaking process that began with an interim final rule in 2004 and was followed by interim final rules in 2005 and 2008. In addition to the restrictions in this final rule, FDA has other specific requirements regarding record maintenance, retention, and accessibility, for manufacturers and processors of human foods or cosmetic products made with material from cattle.