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.

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants.  The final guidance updates the FDA draft guidance originally issued on January 18, 2001.  Under the guidance, food manufacturers may voluntarily label their foods with information about whether the foods were or were not produced using bioengineering, as long as such information is truthful and not misleading.  However, FDA suggests that food manufacturers use terms such as “not bioengineered,” “not genetically engineered,” and “not genetically modified through the use of modern biotechnology” rather than “not genetically modified,” “non-GMO,” or “GMO free.”  Also on November 19, FDA issued draft guidance on labeling genetically engineered salmon, a topic we cover in a separate blog post.

FDA uses the terms “genetic engineering” and “bioengineering” to describe the use of modern biotechnology to develop new plant varieties.  In technical terms, modern biotechnology means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection of plants.  FDA prefers the terms “genetic engineering” and “bioengineering” over the broader term, “genetic modification,” based on the potential for the term, without additional qualifiers, to encompass virtually any kind of alteration to the genetic composition of a plant, rather than simply the modifications resulting from modern biotechnology techniques.

FDA also discourages the use of such claims as “GMO free,” “GE free,” “does not contain GMOs,” and “non-GMO” to indicate that a food is made without ingredients derived through the use of biotechnology.   FDA views  “free” to mean there is a  total absence of components derived through the use of biotechnology, and observes that a claim suggesting that a food product is entirely “free” of components derived from genetically modified plants could be difficult to substantiate.  FDA also takes issue with the “GMO” term, noting that the “O” refers to “organism,” and foods generally do not contain entire “organisms.”

Manufacturers can substantiate a genetic engineering-related labeling claim through a few means.

  • Manufacturers can substantiate claims using documentation of handling practices and procedures, including certifications from farmers, processors, and others in the food production and distribution chain.
  • Manufacturers can substantiate a “not genetically engineered” claim by using certified organic food, because foods that comply with 7 CFR part 205 (USDA organic regulations) would meet criteria to be labeled as not produced or handled using bioengineering.  Documentation of compliance with the USDA organic certification requirements and recordkeeping requirements for certified operations would be sufficient to substantiate a food labeling claim that a food was not produced using bioengineering.
  • Although validated analytical methods may be useful in confirming the presence of bioengineered material in food derived from genetically engineered plants or food ingredients, FDA cautioned that for many foods, particularly for highly processed foods such as oils, it may be difficult to differentiate between plant-derived food developed through bioengineering and plant-derived food developed using traditional breeding methods. Therefore, tests may be less useful in demonstrating the absence of bioengineered material in food derived from genetically engineered plants or food ingredients. Moreover, the specific analytical methods necessary to detect bioengineered material likely will change as new bioengineered plant varieties are introduced to the marketplace, so firms may have to update tests and then routinely and methodically (e.g., shipment by shipment or lot by lot) analyze their ingredients or products for bioengineered material. If validated test methods are not available or reliable because of the way a plant-derived food is produced or processed, it may be more practical to substantiate a claim for such foods differently, such as documenting handling practices and procedures.

As we covered in a previous blog post, FDA recently requested comments regarding the proper meaning and use of “natural” in the labeling of foods, including whether genetically engineered ingredients can be “natural.”

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register notice and subsequently has been included in the Code of Federal Regulation (21 CFR 104.20) even though the policy was never subjected to notice and comment rulemaking and does not qualify as a legally binding “rule,” but rather as agency “guidance.”  From the beginning, FDA’s fortification policy has been designed to discourage the “indiscriminate addition of nutrients to food” and “establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods.”

The new Guidance restates and elaborates upon the food fortification principles stated in the established 1980 fortification policy.  The Guidance does not reference a specific provision of the Federal Food, Drug & Cosmetic Act (FDCA) as the basis for its authority to maintain or enforce the fortification policy, but signals the agency’s readiness to rely on the misbranding provisions of the statute in taking enforcement actions against fortified snack foods. Notably, the “Statement of Purpose” for FDA’s established fortification policy in 21 CFR 104.20(a) attempts to draw a link between the fortification policy and FDA’s authority to prevent deceptive or misleading claims under its misbranding authority without elaboration or support:  “[R]andom fortification of foods could result in over- or under fortification in consumer diets and create nutrient imbalances in the food supply.  It could also result in deceptive or misleading claims for certain foods.”

The new Guidance further addresses the potential for “inappropriate” fortification to result in misbranding violations in the context of fortified snack foods and suggests that fortification of “snack foods could mislead consumers to believe that substitution of naturally nutrient dense foods with fortified snack foods would ensure a nutritionally adequate diet.”   The new Guidance goes on to suggest that “fortification of such snack foods would disrupt public understanding about the nutritional value of individual foods and thereby promote confusion among consumers, making it more difficult for them to construct diets that are nutritionally adequate.”  The new Guidance does not cite any quantitative or qualitative research for the notion that fortification of snack foods will result in consumer confusion.

While recognizing explicitly that the FDA fortification policy does not establish “legally enforceable responsibilities,” the new Guidance urges food manufacturers that elect to add nutrients to a food for human consumption to follow the principles of the fortification policy, including the following guidelines:

  • Principles of “Rational Fortification.” The Guidance states that there are four primary “principles of rational fortification,” which were also part of the established 1980 fortification policy.  Those principles permit the addition of essential nutrients to food for purposes of:
    • Correcting a dietary insufficiency;
    • Restoring nutrient levels to those prior to storage, handling, and processing (the restoration principle);
    • Providing a balance of vitamins, minerals and protein in proportion to the total caloric content of the food (nutrient-to-calorie balance principle); and
    • Preventing nutrient inferiority in a food that replaces a traditional food in the diet.

The Guidance cites as an example of rational fortification the addition of calcium to a soy beverage because a soy beverage would be a reasonable vehicle for people who do not drink milk, such as those who are lactose intolerant, but wish to obtain calcium, and essential nutrient (mineral).

  • Conditions that Added Nutrient Should Satisfy.  The Guidance states that, before a nutrient is added to food, manufacturers should ensure that the nutrient is:
    • Stable in the food under customary conditions of storage, distribution, and use;
    • Physiologically available from the food.
    • Added at an “appropriate level to avoid excessive intake of that nutrient, considering cumulative amounts from all sources in the diet” (e.g., level does not exceed an existing upper intake level (UL) established by the Institute of Medicine (IOM));
    • The nutrient is “suitable for its intended purpose” and complies with FDA safety requirements (e.g., GRAS or approved food additive).
  • “Inappropriate Fortification.”  The Guidance states that “it is not appropriate to fortify certain foods, such as” fresh produce, meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.  As noted above, the Guidance also states that it is inappropriate to fortify unsweetened carbonated beverages, low-calorie and calorie-free snack foods (e.g., low calorie or fat free cookies), and alcohol beverages.
  • “Essential Nutrients.”  The Guidance states that only the addition of “essential nutrients” to food is covered by FDA’s fortification policy.  “Essential nutrient” refers to the vitamins and minerals assigned Reference Daily Intakes (RDIs), and to protein and potassium which have been assigned Daily Reference Values (DRVs).
  • “Mandatory” and “Voluntary Fortification.”  The Guidance states that FDA uses the principles in the fortification policy in issuing regulations requiring nutrients to be added to food, such as standards of identity regulations that require folic acid to be added to various enriched grain products (mandatory fortification).  In addition, the Guidance states that manufacturers “should also follow the fortification policy” described in the Guidance for “voluntary fortification” of foods, including when the following types of foods are fortified:
    • Foods that do not have a standard of identity;
    • Nutritionally modified versions of foods that have a standard of identity (e.g., orange juice with added nutrients);
    • Foods that qualify for a “healthy” claim as a result of added nutrients.
  • Excluded Foods. The Guidance states that FDA’s fortification policy does not apply to animal foods, infant formulas, or dietary supplements.
  • Enforcement.  The Guidance states that FDA’s fortification policy is primarily used as “guidance,” but has incorporated by reference the provisions of the fortification policy into the nutrient content claim regulations for two nutrient content claims: (1) “more” claims (and synonyms “fortified,” “enriched,” “added,” “extra,” and “plus”; and (2) “healthy” claims (and related claims “healthful,” and “healthier”).  If a fortified food does not comply with FDA’s fortification policy and is marketed with express or implied “more” or “healthy” claims,  the Guidance suggests that “FDA may issue a warning letter and take enforcement action.”

FDA issued the guidance as a final guidance, rather than as a draft guidance to be finalized as a letter date.  As it typically does with non-draft guidance documents, FDA is accepting written comments without a specified deadline for submission of comments.

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S. Postal Inspection Service, the IRS, the Department of Defense, and the U.S. Anti-Doping Agency. The event was flush with provocative statements by agency officials painting “dietary supplements” categorically as dangerous and improperly labeled and marketed. The following are just a few examples.

  • Department of Justice: “Almost every day, news sources . . . feature stories about the dangers of dietary supplements. A supplement is laced with an undeclared pharmaceutical ingredient. A study is released about adverse health effects of a so-called natural remedy. An athlete or member of the military falls ill after taking an untested energy product. These stories arise across the country all too often. Consumers turn to supplements when they want to lose weight, get an edge in athletic performance, or improve their overall well-being. From California to Maine, consumers ingest pills, powders, and liquids everyday not knowing if they do what they claim to do.”
  • Department of Defense: “Ensuring the readiness of the force is one of the Department’s top goals. Supplements are a top threat. Why do I say that?  More than 70% of active duty service members take some type of supplement. We also know that 20% of those take performance-enhancing, bodybuilding, or weight loss supplements.”
  • U.S. Postal Inspection Service: “Health can suffer if none of the advertised claims work, [and products] can even pose health risks. The U.S. Postal Service helps to halt scammers from selling their wares to unsuspecting citizens. Working with law enforcement, we hope to protect the American consumer by keeping these scams at bay through a multi-pronged approach of prevention, education, and prosecution.”

In the course of the press conference, bare assertions were made concerning allegedly violative dietary supplement products despite the lack of any fact finding or legal ruling by any court to date, and settlements were listed as legal victories for the government, even though companies routinely settle cases to forego the cost and uncertainties of litigation regardless of actual liability. Unfortunately, this questionable PR event was conducted in a manner that failed to recognize or respect the many responsible companies that make up the “dietary supplement” industry that have a strong track record for legal compliance. In addition, the PR event was a due process disappointment in its tendency to characterize named defendants as virtually certain wrongdoers. After all, the defendants are just that – defendants. The defendants have not yet “had their day in court” and may not have even had a chance to consider litigation or a settlement. Due process has had better days in Washington.

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following:

  • Should FDA define the meaning of “natural” through notice and comment rulemaking?
  • Should FDA prohibit “natural” claims?
  • If FDA defines the meaning of “natural” for labeling purposes, what types of foods should be allowed to qualify as “natural”?
  • Should only raw agricultural commodities qualify as natural?
  • Should multi-ingredient foods be labeled as “natural” and, if so, what types of ingredients should be disqualified?
  • Should the term account for agricultural production practices (e.g., biotechnology, pesticides, animal husbandry practices)?
  • Is there evidence that consumers associate “natural” with “organic” claims?
  • What are the public health benefits of FDA defining the term “natural”?
  • Should “natural” have some nutritional benefit associated with the food?
  • How would FDA determine whether a food labeled as “natural” complies with any criteria for the claim?

FDA has a long-standing policy for the use of the term “natural” for human foods, providing that “natural” means that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. But this policy is only informal, and FDA has declined to adopt a formal regulation pertaining to the term “natural.”  As such, in Holk v. Snapple Beverage Corp., 575 F.3d 329 (3d Cir. 2009), the Third Circuit determined that the FDA policy did not preempt state law claims.  Since the Holk decision, other courts have ruled similarly.  There has been a deluge of consumer class action litigation involving legal challenges to “natural” claims in recent years.

FDA decided to invite public comment concerning the regulation of “natural” claims in food labeling, in part, because it received three citizen petitions, from the Grocery Manufacturers Association, Sara Lee Corp., and The Sugar Association, asking that the agency define the term “natural” for use in food labeling. FDA also received a citizen petition from the Consumers Union asking that the agency prohibit the term “natural” in food labeling.  In addition, several federal courts have requested administrative determinations from FDA regarding whether food products containing ingredients produced using biotechnology or foods containing high fructose corn syrup may be labeled as “natural” under the Federal Food, Drug and Cosmetic Act.

FDA announced that, during its review, it will work with the USDA’s Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term “natural” in meat, poultry, and egg products.

The relevant docket number is FDA-2014-N-1207. The comment period will be open for 90 days, and comments can be submitted electronically or in hard copy.

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