Food and Drug Law Access

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

Posted in Foods and Beverages, Product Labeling & Marketing

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

Posted in Drugs, FDA, Foods and Beverages, Product Labeling & Marketing, Product Safety

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

Posted in FDA, Foods and Beverages, Regulation

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

Posted in FDA, Foods and Beverages, Product Labeling & Marketing

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”

Posted in FDA, Foods and Beverages, Product Labeling & Marketing

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

Posted in Dietary Supplements, Enforcement, FDA, FTC

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

Posted in FDA, Foods and Beverages

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.

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

Posted in Drugs, FDA

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug procedures.  The stay serves to encourage scientific research into the relationship between diet and health while FDA considers numerous comments questioning the novel application of IND rules to foods, dietary supplements, and cosmetics. The stay is effective immediately.

Specifically, the FDA has stayed parts of the subsection on conventional foods (VI.D.2), and all of the subsection on studies intended to support health claims (VI.D.3), with one exception: the stay of the health claim subsection does not apply to clinical studies that include:

  • children under one year of age;
  • people with altered immune systems; or
  • people with serious or life-threatening medical conditions.

As a result of the stay, researchers and sponsors of studies to determine whether a conventional food or dietary supplement may reduce the risk of a disease and that are intended to support a new or expanded health claim do not need to obtain an IND, unless the study population includes members of these sensitive groups.  In addition, researchers and sponsors of studies of non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND while the stay is in effect.  Importantly, however, the stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  Foods and dietary supplements used for those purposes are considered drugs under FDA rules.

Historically, FDA had required Investigational New Drug Applications to be filed prior to clinical research on unapproved “new drugs” primarily to enable pharmaceutical companies to develop the scientific evidence necessary to support FDA approval and commercialization of new drug products.  But in September 2013, the Final Guidance broadly expanded the scope of studies subject to the IND requirements, targeting clinical research involving articles of food, dietary supplements, and cosmetics to IND requirements, even though those products are not “drugs” under the Food, Drug, and Cosmetic Act when they are not intended to diagnose, cure, mitigate, treat, or prevent a disease.  In response to multiple comments asking for a further opportunity to comment on subsections VI.C (relating to cosmetics) and VI.D (relating to foods), FDA reopened the comment period as to those subsections.

During the comment period, FDA received comments from trade organizations, individual companies, scientific associations, public interest organizations, and individuals discussing the effect of FDA’s expansion of the IND process.  Many of these commenters expressed concern over FDA’s statutory ability to expand the IND rules to foods, dietary supplements, and cosmetics, and also over the practical implications of imposing IND requirements on such a broad range of studies.  Commenters suggested that the new policy would discourage important health research and shift clinical research outside of the United States.  Moreover, the comments questioned whether the new restrictions were justified, considering that the products are subject to existing safety standards, have often been proven safe through years – if not centuries or millenia – of safe consumption, and generally pose less risk than unapproved new drugs.

FDA has said that, during the period of stay, it is taking time to further consider these comments.  We will continue to monitor developments on this issue.

WLF Working Paper Assesses Ninth Circuit Preemption Decision

Posted in FDA, Foods and Beverages, Litigation

In Reid v. Johnson & Johnson, the Ninth Circuit heard an appeal of one of the many state law-based consumer class actions over food labeling. A new Washington Legal Foundation Working Paper by Sarah Roller and Katie Bond assesses the Ninth Circuit’s refusal in Reid to grant preemptive effect to a 2003 FDA letter of enforcement discretion. Johnson & Johnson had made certain label claims based on the 2003 letter, in which FDA sought to expand its existing health claim on phytosterols and heart disease pending final rulemaking. The Working Paper posits that by exercising its enforcement discretion in allowing additional phytosterol claims, FDA balanced the burdens of rulemaking against First Amendment commercial speech considerations and the public health benefit of valid health information reaching consumers as expeditiously as possible. In refusing to acknowledge this important role of the FDA in the area of commercial speech, the Ninth Circuit sets a precedent that threatens a wide variety of truthful, FDA-allowed claims – not the least of which are qualified health claims which rely entirely on FDA letters of enforcement discretion. The new Working Paper reviews Reid, assesses its implications, and examines where other circuits stand on preemption and FDA letters of enforcement discretion.

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

Posted in Biologics, Drugs, FDA, FTC, Regulation

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs.  The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request for “comments on other matters related to the development and regulation of drug and biological products labeled as homeopathic.”

Under its 1988 Compliance Policy Guide (CPG), FDA permits the manufacture and distribution of OTC homeopathic products without FDA approval provided certain conditions are met including that they are “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms).”  Conversely, products offered for conditions not amenable to OTC use must be marketed as prescription products and be approved by FDA prior to being manufactured or distributed.  In encouraging FDA to reconsider this framework, FTC staff suggested that FDA’s requirement that homeopathic drugs display an indication for use “even when the product has not been demonstrated to be efficacious for that indication” is inconsistent with the FTC’s requirement that health claims be substantiated by competent and reliable scientific evidence.  FTC staff further noted that the potential conflict does not exist for other products such as dietary supplements and non-homeopathic drugs because both FTC and FDA law require substantiation to support efficacy claims for non-homeopathic products.

The comment also cites a National Advertising Division (NAD) case in which an advertiser defended its claims for a homeopathic product on the grounds that neither the FDA nor the FTC required substantiation for such claims.  Staff noted that the FTC has always required substantiation for such claims, but that “staff has been reluctant to pursue cases against OTC homeopathic products because the Commission’s traditional remedies, such as requiring that health claims be supported by competent and reliable scientific evidence, could create a potential conflict with FDA policy under the CPG.”  Staff also cited consumer research suggesting that many consumers do not understand the nature of homeopathic products, how they are regulated, or the level of substantiation required for such products as further support for FDA reevaluating its approach.

While the staff comment did not expressly advocate for a particular resolution, it noted that the current potential conflict could be resolved in three ways: (1) FDA withdrawing the CPG and subjecting homeopathic drugs to the same regulatory requirements as other drug products, (2) FDA eliminating the requirement in the CPG that an indication appear on the labeling, or (3) FDA requiring any indication appearing on the labeling to be supported by competent and reliable scientific evidence but otherwise maintaining the current regulatory approach.  While not noted in the comment, the second approach, however, would not seem to address FTC’s concerns about consumer confusion as to the efficacy and nature of homeopathic products.

The comment period for submission of comments to FDA closed on Friday, August 21.  We will continue to monitor developments related to the regulation of homeopathic products here.