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  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it will be re-considering the criteria for “healthy” and similar claims.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.

Identity Crisis Over: Dietary Supplements Can Be “Dietary Supplements”

In its dietary supplement labeling guide, first issued in April 2005, FDA advised that it would not consider the term, “dietary supplement,” alone, to be an appropriately descriptive “statement of identity.” FDA, however, has now reversed course. Revised guidance released last week now provides as follows:

Can the term “dietary supplement” by itself be considered the statement of identity?

Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement.”

The revised guidance also adds the following: “Dietary supplement” may be included as “part of a longer statement of identity (e.g., ‘cod liver oil liquid dietary supplement’).”

After WTO Battle, USDA Issues Final Rule Lifting Pork and Beef COOL Requirements

Today, following a protracted legal battle at the WTO, USDA issued a final rule removing mandatory Country of Origin Labeling (COOL) requirements for muscle cut and ground beef and pork.

Beginning in 2008, Canada and Mexico challenged the COOL requirement, arguing that it discriminated against non-U.S. meat and was outside the bounds of permitted rules that WTO signatories can adopt.   Following WTO rulings against the United States, USDA amended the rule in 2013.  The revised COOL rule was also found to be non-compliant with WTO standards.  In 2015, arbitrator granted Canada’s request for authorization from the WTO to suspend the application of certain tariff concessions for the U.S.  Shortly thereafter, Congress voted in the Consolidated Appropriations Act of 2016 to remove the COOL requirement, and USDA stopped enforcing the rule as of December 18, 2015.

As a result of this change, retailers and their suppliers are no longer required to convey country of origin information for beef or pork products to their buyers or consumers under the mandatory COOL program.  However, imported beef and pork products sold in consumer-ready packages must still bear the foreign country of origin under Customs and Border Protection and USDA’s Food Safety and Inspection Service (FSIS) regulations.

COOL regulatory requirements for chicken, lamb, goat, farm-raised and wild caught fish and shellfish, perishable agricultural commodities, peanuts, pecans, macadamia nuts, and ginseng remain in effect and are not effected by USDA’s action.

Coalition Challenges National Marine Fisheries Service Rules for Regulating Offshore Aquaculture in the Gulf of Mexico

On February 12th, a coalition led by the Center for Food Safety filed suit in the U.S. District Court for the Eastern District of Louisiana challenging the National Marine Fisheries Service’s (“NMFS”) final rule implementing the Fishery Management Plan for Regulating Offshore Aquaculture in the Gulf of Mexico (“FMP”). The rule is the first FMP for domestic aquaculture for species managed by the Gulf of Mexico Fishery Management Council (“Council”), and the first broad-scale specific authorization for offshore aquaculture in the United States.

The Council approved the FMP in 2009; however, NMFS did not implement its measures as a final rule until January 13, 2016. In the interim, two national policies on aquaculture were adopted: (1) NMFS issued a Marine Aquaculture Policy in 2011; and (2) the Interagency Working Group on Aquaculture released a draft National Strategic Plan for Federal Aquaculture Research in 2014.

According to the Council, the FMP applies to activities that constitute “rearing of aquatic organisms in controlled environments (e.g., cages or net pens) in federally managed areas of the ocean.” It authorizes up to 20 Gulf Aquaculture Permits, for a term of ten years each, up to a total annual production of 64 million total pounds. Any individual permit holder may only produce 20% of that annual total. The FMP also requires a dealer who receives fish cultured at an offshore aquaculture facility to possess a Gulf aquaculture dealer permit. A permit allows harvest of all native Gulf species that are managed by the Council, excluding shrimp and corals.

There are currently no commercial offshore aquaculture operations in federal waters for finfish rearing. There are 25 permit holders for live rock aquaculture in the United States’ Exclusive Economic Zone, as well as several aquaculture operations in state waters of California, Florida, Hawaii, Maine, New Hampshire, and Washington.

The FMP has several mechanisms for regulating offshore aquaculture, including the overall harvest limit for the fishery noted above. The Council set that harvest limit (referred to as “optimum yield” in keeping with legally-mandated principles for wild-caught fishery stocks) equal to the average annual landings of all marine species in the Gulf, except menhaden and shrimp, between the years 2000 and 2006. Entry to the fishery may be limited in subsequent years if the overall harvest level is exceeded. The FMP also contains siting requirements, obligates permit applicants to conduct a baseline environmental assessment off the proposed site prior to permit review, and requires extensive and routine monitoring and reporting once operations are underway.

The legal complaint, filed by twelve organizations representing fishery interests and environmental and food safety groups, alleges that industrial aquaculture is sufficiently different from fishing that NMFS does not hold permitting authority over its regulation. Rather, the complainants believe that it should be regulated more akin to farming practices. While FMPs are typically used to manage single- or multiple-stock wild-caught fisheries, fishery management councils have utilized them with some flexibility in the past for purposes such as ecosystem-based management.

NMFS, for its part, counters that all offshore fisheries, including aquaculture, are most appropriately regulated under the Magnuson-Stevens Fishery Management and Conservation Act. On February 23rd, NMFS’ Deputy Assistant Administrator for Regulatory Programs, Sam Rauch, testified before the Senate Commerce Committee’s Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard that, while setting optimum yield for aquaculture is “a little awkward,” the agency feels that the Magnuson-Stevens Act provides sufficient statutory authority for managing offshore aquaculture.

The complaint further alleges that the FMP does not adequately address how aquaculture will affect the survival of wild fish. The topic of large-scale commercial aquaculture has traditionally been controversial in the United States. Opponents’ major concerns are that escapes from aquaculture pens could affect wild populations through genetic modification or disease, and that operations will adversely affect the environment through waste and chemical contamination.

NMFS has argued in the regulatory documents that reporting requirements minimize such risks, and that permitting operations will benefit the nation by increasing the supply of in-demand local species such as snappers, groupers, red drum, cobia, and jacks.

Court Temporarily Tables Controversial NYC Salt Warning Rule

In September 2015, the New York City Board of Health unanimously passed a unique measure that would require chain restaurants to warn consumers about the sodium content of certain menu items.  In particular, restaurants with 15 or more locations nationwide would be required to show images of saltshakers next to menu items with 2,300 or more milligrams of sodium.  Fines under the rule were set to begin on March 1.

But today, just a day before the March 1 effective date, a New York appeals court granted the National Restaurant Association’s request for a temporary stay, meaning enforcement of the rule will be halted.   A lower court had upheld the measure and last week denied the NRA’s request for a preliminary injunction, deciding that the requirement was consistent with federal law and that the warning did not harm restaurants’ rights to sell higher sodium foods or consumers’ personal autonomy.  The NRA had argued that the law was arbitrary and capricious and could not be properly adopted by the Board of Health.

The rule will be temporarily stayed with the appeals court can consider the NRA’s preliminary injunction request.

Separate from New York City’s unique salt labeling rule, a federal law requiring chain restaurants to post certain nutrition information was passed in 2010.  A final rule implementing that law was issued in 2014 year, although the deadline for compliance has been extended until December 2016.  Unlike New York City’s rule, the federal law would not require restaurants to post sodium content on menus.

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat post-traumatic stress disorder, lupus, cancer, and other conditions rendered the products unapproved new drugs.

This February, FDA again turned its attention to CBD products, issuing eight new warning letters. For the first time in an enforcement context, FDA contended that CBD products fail to meet the FDCA definition of a “dietary supplement.” The agency explained as follows:

FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 C.F.R. § 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act, but you may present the agency with any evidence that has bearing on this issue.

The cited portion of the “dietary supplement” definition is discussed in FDA’s controversial 2011 draft guidance on new dietary ingredients. FDA committed to revising that guidance in 2012. Revised guidance has yet to be released.

In each of the new warning letters, FDA again identified claims that it believed rendered products unapproved new drugs. This time, however, identified claims were drawn from not only company websites, but also product descriptions on Etsy and company posts on Facebook, Twitter, and Pinterest.  We discussed FDA and FTC regulation of social media in an article published in Nutritional Outlook. In general, regulators treat social media posts by companies the same as any other labeling or advertising. Regulators may treat posts by consumers as labeling or advertising where a company “likes,” comments on, or republishes a post.

San Francisco Backpedals on Ad Ban for Sugary Drinks, but Maintains Warnings Requirements

In June 2015, the San Francisco Board of Supervisors passed two sweeping ordinances concerning sugar-sweetened beverages designed to “inform the public of the presence of added sugars” and restrict certain advertising for these products.  The first ordinance requires warnings on certain advertisements for sugar-sweetened beverages to advise consumers about the “harmful health effects of consuming such beverages,” and authorize the Director of Health to impose penalties for noncompliance (“Warning Requirement”).  The second ordinance prohibits advertising of such beverages on City property, and requires the following warning label to be placed on ads on city billboards, buses, transit shelters, posters, and stadiums: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes and tooth decay” (“Advertising Ban”).

Understandably, the American Beverage Association filed a First Amendment challenge against the City for the two ordinances, as well as a preliminary injunction requesting that the court stay the Advertising Ban, which would have become effective July 25, 2015.  Specifically, the ABA alleged that the Warning Requirement: (1) constitutes the type of content-based discrimination to which courts have applied a heightened scrutiny; (2) does not directly and materially advance the City’s interest because it contains a number of exemptions that undermine the mandate; and (3) is unduly burdensome.

In addition, the ABA alleged that the Advertising Ban on City property: (1) constitutes viewpoint discrimination, since the City is prohibiting speech on certain subjects on public property, but allowing other directly contrary speech to occur; (2) constitutes discrimination based on identity under certain circumstances because it prohibits (with limited exceptions) any use of a company’s name in advertisements if that company produces a sugar-sweetened beverages; and (3) constitutes an unconstitutional prior restraint on speech, since it prohibits covered entities from utilizing their names in some public places.  On August 25, the City asked the court to enter a stipulation and order stating that it agreed not to enforce the Advertising Ban while ABA’s suit was pending.

On December 1, the Board of Supervisors unanimously voted to repeal the Advertising Ban, saying that the repeal was prompted by the U.S. Supreme Court’s recent decision in Reed v. Town of Gilbert, Arizona, striking down a similar content-based speech restriction.  In Reed,  the municipal code imposed more stringent restrictions on signs directing the public to a church than on signs conveying other messages.

Despite the repeal of the Advertising Ban, the Warning Requirement is still at issue.  The ABA’s constitutional challenge of the Warning Requirement is still pending in federal court.

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal drug provisions of the Federal Food, Drug & Cosmetic Act, as explained in FDA’s 2009 guidance document.  The approval of the application is historic as it marks the first time that FDA has approved the use of a genetically engineered animal intended for use as food.

FDA initially held a public hearing in September 2010 regarding the legal principles governing GE salmon and to solicit comments related to FDA’s consideration of whether there were any “material” differences between GE and non-GE salmon, and how food labels could truthfully and adequately disclose any such differences.  The agency noted that it reviewed over 30,000 written comments in response to the public hearing.  In announcing the approval of the AquAdvantage Salmon, FDA explained that extensive data demonstrated that the GE salmon is “as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.”  Because it determined that AquAdvantage Salmon was not materially different than other Atlantic salmon, FDA concluded that it was inappropriate to impose mandatory labeling requirements disclosing that the salmon was produced using modern biotechnology.

The agency also found that the approval would not have a significant impact on the U.S. environment because of the multiple forms of physical and biological containment proposed by the applicant, AquaBounty Technologies.  Notably, the application only permits AquAdvantage Salmon to be raised on land-based contained hatchery tanks in two specific facilities in Canada and Panama; it does not permit the salmon to be bred or raised in the United States.  The agency also noted that the salmon are reproductively sterile so they would be unable to interbreed even in the highly unlikely event that they would somehow be introduced into the wild.

At the same time as announcing the approval of the salmon, FDA released two guidance documents related to voluntary labeling of food from genetically engineered sources.  A separate blog post discusses the final guidance on voluntary labeling indicating whether food has or has not been derived from GE plants, which finalizes a January 2001 draft guidance.  The agency sets forth similar principles in a second guidance targeted to the issue of GE salmon, which it released in draft form, entitled “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon”:

  • Mandatory labeling inappropriate.  The draft guidance explains that because of FDA’s conclusion that “there is no material difference between food derived from AquAdvantage Salmon and food derived from other non-GE, farm-raised Atlantic salmon,” the agency is not imposing unique mandatory labeling requirements on GE salmon.
  • Certain voluntary labeling claims acceptable.  The draft guidance notes that while FDA considers mandatory labeling requirements unsupportable due to the lack of material difference between GE and non-GE salmon, it recognizes that some consumers are interested in knowing whether a food is derived from GE salmon.  The draft guidance suggests use of the following statements on a voluntary basis to convey to consumers that a food is not derived from GE salmon:
    • “Not genetically engineered.”
    • “Not genetically modified through the use of modern biotechnology.”
    • “We do not use Atlantic salmon produced using modern biotechnology.”
  • Certain voluntary labeling claims potentially misleading.  The draft guidance notes that other currently used voluntary claims may be misleading to consumers, including “not genetically modified,” and “non-GMO” because FDA considers the term “genetic modification” to be a much broader and harder to substantiate term than “genetic engineering.”  Nonetheless, the draft guidance indicates that FDA does not intend to take enforcement action against foods using such claims, provided the food actually is not produced through the use of modern biotechnology.
  • Context is important for labeling claims.  The draft guidance emphasizes that manufacturers must consider the broader context in which claims appear in order to evaluate whether a particular claim is false or misleading.  For example, FDA notes that the claim “None of the ingredients in this food are genetically engineered” could be misleading if certain ingredients are incapable of being produced through genetic engineering (e.g., salt).  Moreover, a statement regarding the absence of genetic engineering would be misleading if the broader label suggests that the food is safer, more nutritious or otherwise materially different than the food produced using modern biotechnology.

The agency will accept comments on the draft guidance until January 25, 2016.

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

Word gluten free written in white flour on a old wooden table from top view in vintage tone, surrounding by baking tools.

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients.

Word gluten free written in white flour on a old wooden table from top view in vintage tone, surrounding by baking tools.

The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods. Under the 2013 final rule, manufacturers could label their products as “gluten-free” if it does not: (a) contain an ingredient that is a gluten-containing grain; (b) an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten; or (c) an ingredient that is derived from a gluten-containing grain, and that has been processed to remove gluten, if the use of that ingredient.

At its core, the proposed rule would amend the FDA’s existing gluten-free rule to provide alternative means for FDA to verify compliance for fermented, hydrolyzed, or distilled foods (including beverages, such as beer) based on records maintained by the manufacturer of the food.  Specifically, manufacturers would be required to make and keep records demonstrating assurance that:

  1. The food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis;
  2. The manufacturer has adequately evaluated its process for any potential gluten cross-contact; and
  3. Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

The FDA, however, is soliciting comments and data to determine if, and to what extent, manufacturers of fermented or hydrolyzed foods can adequately quantify the gluten content contained in the final product.  Among other things, the FDA is requesting:

  • Comments, including scientific data, on any studies that have been conducted to demonstrate whether any fermentation or hydrolytic processes sufficiently break down gluten into peptides that are harmless to persons with celiac disease;
  • Research into methods that can be used to quantify the gluten protein content in fermented or hydrolyzed foods in terms of intact gluten, including the use of ELISA-based methods and Mass Spec testing;
  • Comments and data on the feasibility and circumstances under which a food can be processed to remove gluten and the methods by which the absence of gluten can be determined;
  • Comments and information relating to the removal of gluten in beers, including: (1) efficacy of competitive ELISA-based methods; (2) the effect of enzymes used to break down the gluten; and (3) scientific research regarding whether beer derived from gluten-containing grains that may still contain protein fragments from gluten.

The comment period is open for 90 days, and comments can be submitted through February 16, 2016.

In addition, the FDA is also soliciting comment on the related information collection issues under the Paperwork Reduction Act.  These comments must be submitted by December 18, 2015.