On March 26, 2014 the Food and Drug Administration (FDA) issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Agency’s implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act (FDCA).
Under the “pre-FSMA” provisions of the FDCA establishing RFR requirements, companies operating registered food facilities are required to submit reports to FDA after discovering food safety hazards that would generally merit a “class I” food recall, or when the company determines that “there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animal” (“SAHCODA”). These reports to FDA concerning SAHCODA hazards are required even when the SAHCODA hazard relates to a product that the company did not manufacture.
The FSMA amendments to the FDCA further expand RFR requirements in ways that are designed to ensure that foods affected by SAHCODA hazards that have been reported to FDA are promptly brought to the attention of consumers. The report should include “consumer-oriented” information, or be tailored to enable a consumer to accurately identify whether the consumer is in possession of a reportable food. After receiving the report, FDA must publish on its website a one-page summary of the information. FSMA requires chain grocery stores with 15 or more physical locations to prominently display the summary within 24 hours after publication if the stores sold a reportable food that is the subject of the summary. The RFR requirements cover foods that are not under the exclusive jurisdiction of the U.S. Department of Agriculture, which include human and animal food or feed regulated by FDA. Notably, the RFR requirements do not cover dietary supplements and infant formula. These products are addressed in other mandatory reporting systems in the FD&C Act.
According to the ANPR, FDA seeks comments on topics such as the following:
- What information necessary to enable consumers to identify a reportable food;
- What are the best methods for posting consumer notifications; and
- Which types of grocery stores that should be subject to the requirements.
Comments can be filed online or on paper and must be received by FDA on or before June 9, 2014.
The FDA today released a Draft Guidance that offers a definition for “honey” without formally establishing a standard of identity and cites to existing laws and regulations to respond to questions regarding the proper labeling of honey and honey products. The Draft Guidance follows FDA’s 2011 denial of a petition for a standard of identity for honey based on the 2001 Revised Codex Alimentarius Commission’s Standard for honey. According to FDA, a standard of identity for honey is not necessary to promote honesty and fair dealing because honey already has a commonly understood meaning as “a thick, sweet syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.”
In the Draft Guidance, FDA explains that products that contain ingredients other than honey, as defined above, would be misbranded and potentially adulterated under the Federal Food, Drug & Cosmetic Act (FDCA) if they are labeled as “honey” without disclosing the other ingredients. For instance, the Draft Guidance notes that products that contain both honey and a sweetener should employ a common or usual name that clearly discloses both ingredients (e.g., “blend of honey and sugar” or “blend of corn syrup and honey”) consistent with 21 C.F.R. 101.25(a). Products that contain a flavoring ingredient should similarly disclose that ingredient as part of the common or usual name (e.g., “raspberry flavored honey”).
In addition to misbranding violations, the Draft Guidance notes that a product that fails to disclose the presence of a less valuable constituent such as a non-honey sweetener would be considered adulterated under FDCA section 402(b), which prohibits the addition of any substance to “make [the food product] appear better or of greater value than it is.” The Draft Guidance notes that FDA has a longstanding import alert for honey with cane or corn sugars and honey that appears to contain residues of chloramphenicol and fluoroquinolones.
While comments can be submitted on guidance documents at any time, FDA asked for comments within 60 days in order to ensure consideration prior to work on any forthcoming finalized version of the guidance.
On March 25 and 26, FDA’s Center for Drug Evaluation and Research (CDER) held a public hearing to obtain input on the over-the-counter (OTC) drug review process. Under the OTC Drug Review, FDA was able to determine, by therapeutic category, that thousands of OTC drug products were generally recognized as safe and effective (GRAS/E). FDA has issued final monographs for the majority of the original drug categories (codified at 21 CFR parts 331 to 361), with final rules that cover large segments of the OTC marketplace. Examples include fluoride toothpastes, acne products, and topical antifungals. Yet several remain unfinished while others need to be updated to reflect changes in science. FDA “is interested in exploring ways to re-engineer the process of regulating OTC drugs that are currently regulated under the OTC Monograph Process to, among other things, create a process that is more efficient and more responsive to newly emerging information and evolving science, and to allow for more rapid product innovation where appropriate.”
The hearing comes at a time of frustration with the monograph process and, in particular, the lack of clarity from FDA regarding its position on novel modes of delivery for active ingredients, or approval for the use of new ingredients in monograph products that have safely been used in other countries for years. FDA also has yet to finalize monographs for several product categories, which cover thousands of products that are currently marketed under pending tentative final monographs. According to FDA, part of the stagnation in the process is due to FDA’s regulations, which impose a “lengthy” notice and comment rulemaking process, including the publication of an Advanced Notice of Proposed Rulemaking, a Tentative Final Monograph, and a Final Monograph that establishes conditions under which an OTC drug is considered generally recognized as safe and effective and can be marketed.
According to FDA’s Federal Register Notice, FDA seeks comments on the strengths and weaknesses of the existing OTC review process, modernization concepts, and modification of or alternatives to the existing OTC review process. FDA apparently believes that the biggest challenges of the current system are:
- the large number of products marketed under the OTC Drug Review for which there are not yet final monographs,
- limitations on FDA’s ability to require, for example, new warnings or other labeling changes to address emerging safety or effectiveness issues for products marketed under the OTC Drug Review in a timely and effective manner, and
- the inability of the OTC Drug Review to easily accommodate innovative changes to products regulated under the OTC Drug Review.
However, the agency also requests comments that would identify any other scientific or regulatory challenges that are not listed in its notice. The March 25 and 26 hearing regarding the OTC Drug Review included testimony from trade associations, industry, outside counsel, doctors, and pharmacists, who, while in disagreement about the causes of the stagnation and ideal future for the review, nevertheless, stressed their desire for FDA to prioritize and complete the monograph review process. FDA action in this area will greatly impact the consumer health and personal care products industries, which manufacture and sell hundreds of thousands products based on tentative and final OTC drug monographs.
FDA is accepting comments until May 12, and plans to release a transcript of the hearing by April 25. More information regarding the request for comment is available here.
March 15, 2014 was the second anniversary of the implementation of the Korea-U.S. Free Trade Agreement (“KORUS”). This agreement is a tremendous opportunity for companies trading in the food, drug, medical device, and cosmetics industries. South Korea is the seventh largest trading partner of the U.S. and the U.S. is the third largest trading partner of South Korea. As with all free trade agreements, there have been some growing pains as to origin verifications, however the benefits for FDA regulated products are tremendous. Customs duties are eliminated on 95% of qualifying goods within the first five years and the remainder by year fifteen.
The requirements to qualify are the following: 1) The merchandise must be shipped directly between South Korea and the U.S.; 2) The goods must qualify under the rules of origin; 3) The importer must have a written certification that the claimed goods are originating; and 4) The importer must maintain records for five years. Either U.S. or Korean Customs can initiate a verification on eligibility, so it is crucial that the importer can verify the origin prior to production.
How can importers and exporters take advantage of KORUS? Some best practices include developing a process for the origin documents and amending supplier contracts to provide for the delivery of required documentation including the origin certification and bills of material. The importer’s staff must be trained to understand the rules of origin and properly classify the goods. Finally, it is crucial that Government requests for supporting information be responded to in a timely manner.
While a claim for KORUS can be made up to one year after date of importation, it is more efficient to organize the merchandise for duty free entry prior to production. With an understanding of the rules of origin and a process in place for the flow of the required documentation, importers that take advantage of KORUS can enhance their bottom line.
 An exception is for unloading and reloading in a third country, but it must be done under Customs control.
 The merchandise must be wholly obtained or produced entirely in the U.S. and/or Korea exclusively from originating goods or the product is produced entirely in the U.S. and/or Korea and the non-originating materials undergo a tariff shift or the regional value content, if applicable, is satisfied.
On March 3, 2014, FDA published two notices of proposed rulemaking detailing the agency’s proposed revisions to its nutrition labeling requirements. The proposed rules: (1) update the list of nutrients required or permitted to be declared, the Daily Reference Values and Reference Daily Intake values of several nutrients, and the format and appearance of the Nutrition Facts label; and (2) amend certain serving size requirements (which we discuss here). FDA states that it has proposed these amendments in light of current scientific evidence, the most-recent dietary recommendations, and public comments received in response to advance notices of proposed rulemaking. With regard to FDA’s proposed changes to the nutrition labeling requirements, major changes relate to:
- Nutrition Facts Label: FDA proposes to amend the format of the Nutrition Facts label to increase the prominence of the “Calories” and “Serving Size” declarations, change “Amount per Serving” to “Amount per [serving size],” move the “% DV” to the left of the name of the nutrient, and replace “Total Carbohydrate” with “Total Carbs.” These amendments are intended to help ensure that the labels comply with the Nutrition Labeling and Education Act requirement that consumers are able to readily observe and comprehend the information presented and understand its relative significance in the context of their total daily diet.
FDA also introduced, and seeks comment on, an alternate concept for the label format that divides the information presented into “quick facts” about the product’s nutrient content and advises consumers of which nutrients to “avoid too much” and “get enough.”
- Mandatory Nutrient Information: FDA is proposing to amend the list of nutrients that are required or permitted to be declared on the Nutrition Facts label. Specifically, the agency proposes to remove the mandatory “Calories from Fat” declaration because research demonstrates that the type of fat is more important than the amount. In response to several CSPI petitions, and to enable consumers to follow the 2010 Dietary Guidelines Advisory Committee report conclusion that on average Americans get 16 percent of their total calories from added sugars, and recommendation that individuals reduce their intake of calories from added sugars, FDA is proposing to require declaration of “Added Sugars.” “Added Sugars” is defined as sugars, syrups, naturally occurring sugars isolated from a whole food and then concentrated (i.e., concentrated fruit juice), and other caloric sweeteners. Because there currently is no way to distinguish between naturally occurring and added sugars in a finished food product, FDA also proposes to require that manufacturers maintain records, for two years, of the amount of sugars added to food products. The rule would also remove the provision allowing for voluntary declaration of “Other carbohydrate.” Continue Reading
In conjunction with the proposed changes to the nutrition labeling requirements, the FDA is separately issuing a proposed rule that would make significant changes to “reference amounts customarily consumed” (“RACCs”) for certain foods, and existing requirements governing the declaration of serving sizes for nutrition labeling purposes.
Existing FDA regulations prescribe the “RACC” for foods on a category basis. The RACC that applies to a food is the unit amount of a food that must be used by companies to determine the amount of food that constitutes a “serving.” The Nutrition Facts box must declare the “serving size” and the calories and nutrient amounts are provided based on a “serving” of the food. In addition, under existing FDA regulations, for a food to qualify for nutrient content claims (e.g., “high in fiber,” “low in saturated fat”), nutrient levels in the food must meet criteria that are specified on the basis of the RACC.
Specifically, the FDA is proposing major changes to the following areas:
- Single-Serving Containers: FDA is proposing to revise the definition of a single-serving container so that a product that is packaged and sold individually and contains less than 200% of the applicable RACC must be considered a single-serving container, and the entire content be labeled as one serving. In doing so, FDA removes the current exception for foods that have “large” RACCs (i.e., products that have reference amounts of 100 g (or mL) or larger), which currently provides that a package containing more than 150% but less that 200% of the applicable RACC, can be labeled as having one or two servings. This change reflects FDA’s belief that packages which can be consumed, or are typically consumed, in one sitting should be labeled as a single-serving. Continue Reading
The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the document as Final Guidance in September 2013.
The expanded Final Guidance includes new sections indicating that FDA intends to enforce IND requirements when certain types of research are conducted involving food, dietary supplements, or cosmetics. Regarding cosmetics, the Guidance provides that “[a]s a general matter, studies of ingredients or products marketed as cosmetics require an IND if the ingredient is being studied for use to affect the structure or function of the body or to prevent, treat, mitigate, cure, or diagnose a disease.” Similarly, the Guidance provides that “a clinical investigation intended to evaluate the effect of a food on a disease would require in IND under part 312.” The Final Guidance indicates that FDA would enforce the expanded interpretation of IND requirements for food, dietary supplement, and cosmetic studies, notwithstanding the absence of any labeling or marketing claims that would state or imply that the article is intended for use as a drug.
In the notice published today, FDA explained that it has reopened the Final Guidance for public comment only with respect to sections VI.C and VI.D to allow more time for public review of the sections of the Final Guidance concerning foods, dietary supplements, and cosmetics, and consideration of its effects on researchers, health care providers, and others. Comments must be submitted by April 7th.
On February 3, 2014, FDA issued a Direct Final Rule to adjust for inflation the maximum civil money penalty (“CMP”) amounts it can seek for certain violations of the Food, Drug, and Cosmetics Act (“FDCA”). The direct final rule revises the current list of statutory monetary penalties set forth 21 C.F.R. Part 17, including for violations relating to prescription drug marketing practices, medical devices, and direct-to-consumer advertising for approved drugs or biological products, among others.
The FDA is required to adjust the CMP at least once every four years, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990. The last adjustment was made in March 2009. The direct final rule increases the maximum CMP amount anywhere from $1,000 to $25,000 per individual, $10,000 to $25,000 per violation, and $50,000 to $850,000 for multiple violations being adjudicated in a single proceeding.
Since 2009, FDA has used its CMPs authority sparingly; but when it does issue CMPs, FDA really “goes for the gold.” For example, in December 2013, FDA reached a $1.25 million settlement involving allegations that the company manufactured and distributed misbranded and adulterated sterilization monitoring products. Prior to that, the FDA entered into a $1 million settlement in February 2012 resolving allegations that the company distributed unapproved medical devices. With this direct final rule, the FDA will likely continue to seek higher CMP amounts for egregious violations of the FDCA.
FDA’s rule was published as a direct final rule, which means that the agency does not expect there to be any significant adverse comments. The FDA, however, is allowing comments to be submitted until April 21, 2014. If no substantial comments are received, the rule will become effective June 18, 2014.
FDA today released a proposed rule that would prescribe sanitary transportation practices for shippers, receivers, motor and rail carriers, and other companies that are engaged in the transportation of food in the United States. The proposed rule is designed to implement the amendments to the Federal Food, Drug and Cosmetic Act (FDCA) that were made by the Sanitary Food Transportation Act of 2005 (SFTA), which directed FDA to issue such regulations “to ensure that food is not transported under conditions that may render the food adulterated.” In addition, the proposed rule is designed to account for the subsequent amendments to the FDCA that were adopted in 2011 under the FDA Food Safety Modernization Act (FSMA). In its release of the rule, FDA noted that “the proposal marks the seventh and final major rule in the . . . FSMA central framework aimed at systematically building preventive measures across the food system.”
Under the SFTA, FDA’s implementing regulations are required to prescribe sanitary transportation practices with respect to “sanitation,” “packaging, isolation, and other protective measures,” “limitations on the use of vehicles,” and related recordkeeping requirements. Under the FDA proposed rule, transportation companies would be required to ensure that vehicles and transportation equipment are suitable and adequately cleanable in order to prevent the adulteration of food.
The regulations impose distinct obligations on shippers, receivers and carriers. For instance, shippers would be required to specify to the carrier the necessary sanitary requirements pertaining to the carrier’s vehicle and transportation equipment and would be required to visually inspect the vehicle or transportation equipment provided by the carrier before loading food not completely enclosed by a container. Amongst other obligations, carriers would be required to demonstrate to the shipper and, if requested, the receiver, that the carrier has maintained temperature conditions consistent with those specified by the shipper. The proposed rule would also impose certain record retention requirements on shippers and carriers.
The rule would not apply to shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. The rule would apply broadly to all food, as defined in section 201(f) of the FDCA, including conventional food and beverage products, dietary supplements, pet food, animal feed, and raw materials and ingredients. However, the rule would not apply to the transportation of fully packaged shelf-stable foods, live food animals, and raw agricultural commodities when transported by farms.
Comments are due on the proposed rule by May 31, 2014. FDA intends to hold three public meetings on the proposed rule – two in tandem with public meetings scheduled on the proposed rule on the Intentional Adulteration of Food and one standalone meeting.
On January 14, 2014, FDA issued final guidance to help companies determine whether a product qualifies as a “dietary supplement” or “conventional food” as defined by the federal Food, Drug & Cosmetic Act (FD&C). While dietary supplements and conventional foods are both considered “foods” under the FD&C, there are important differences in the regulatory requirements that apply to foods that qualify as “dietary supplements.” The FDA final guidance issued last week, Distinguishing Liquid Dietary Supplements from Beverages, updates FDA’s earlier 2009 draft guidance and, in general, provides greater detail than the draft guidance.
There are important differences in the regulatory requirements that apply to dietary supplements versus conventional foods. The final guidance elaborates on factors that FDA considers in determining the regulatory classification of a liquid product. These factors are discussed below.
- Product Labeling and Advertising Claims—FDA will consider statements and graphics (e.g., symbols, vignettes, pictorial serving suggestions) on a product’s label, labeling, and/or advertising. A product that is marketed as a dietary supplement could be considered a conventional food if it bears claims that the product is intended to “refresh” or “rehydrate,” for example, as these statements likely represent the product for use as a beverage.
- Product Names—FDA believes that certain terms, such as “beverage,” “drink,” “water,” or “soda,” are exclusive to conventional foods and, thus, when used in a product name, represent the product as a conventional food. Where a term is not, in FDA’s view, associated exclusively with conventional foods, the term could be used in conjunction with a dietary supplement product. As an example, the final guidance indicates that products described as “teas” could be either dietary supplements or conventional foods.
- Packaging Design—FDA also will consider packaging characteristics to help determine whether a product should be classified as a conventional food or a dietary supplement. For example, whether a 12 ounce liquid product comes in reclosable packaging would be an important consideration to FDA, as a 12 ounce non-reclosable package more closely resembles a beverage, rather than a dietary supplement.
- Serving Size and Recommended Daily Intake—Like the 2009 draft guidance, the FDA’s final guidance emphasizes that if a product is represented to provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States, the product likely will be viewed as a conventional food.
- Recommendations or Directions of Use—Similar to advertising claims that a product is intended to “refresh” or “rehydrate,” recommended uses for a product that are similar to the purpose of beverages will characterize a product as a conventional food, according to FDA. For example, FDA noted that recommendations or directions to use a product as a thirst quencher can be considered recommendations or directions to use the product as a beverage. Vice versa, recommending that a product be used to supplement the diet in a manner consistent with other dietary supplement directions (e.g., take one tablespoon three times a day) could be a factor in determining that a product is a dietary supplement.
- Marketing Practices—Marketing the product in a manner that causes the product to be compared to conventional food beverages–such as by paying for the product to be displayed in the beverage section of retail stores, using metatags that cause the product to appear in the results of an electronic search for conventional foods, or marketing the product based on taste, refreshment, or thirst-quenching ability—would likely cause FDA to categorize the product as a conventional food.
- Ingredient Composition—FDA noted that it intends to consider the composition of a product as an important factor in determining if a product is a conventional food or dietary supplement (e.g., does a product that is marketed as a dietary supplement consist in significant part of conventional food components unrelated to the supplement’s claimed nutritional or health benefits).
- Other Product Representations—These could include representations about a product’s purpose made in publicly available documents, such as statements made in filings with government agencies, including the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
FDA has stressed that, “in most circumstances a combination of factors would determine whether the product is represented as a conventional food.” The final guidance also clarifies that FDA will generally view powdered premix products intended to be added to liquids and that are labeled as dietary supplements to be appropriately characterized, so long as the product is not represented for beverage use or as an alternative to beverages.
Further, the guidance emphasizes FDA’s intention to ensure that foods are marketed in the proper form to prevent manufacturers from improperly adding ingredients to conventional foods under the mistaken notion that the product is a dietary supplement. According to the guidance, “[m]erely adding an ingredient listed as a dietary ingredient in section 201(ff)(1) of the FD&C Act to a product universally recognized as a beverage does not by itself transform that beverage into a dietary supplement.” As an example, the guidance explains that adding a botanical, such as ginkgo to Kool-Aid, would not automatically create a product that could be marketed as a dietary supplement. Any ingredient added to a conventional food, regardless of whether that product is properly marketed as a conventional food, must be added in conformance with food additive regulations, be generally recognized as safe under the intended conditions of use, or otherwise be exempt from the definition of food additive.
FDA’s final guidance was published on the same day as guidance entitled FDA’s Considerations Regarding Substances Added to Food, Including Beverages and Dietary Supplements. See our Food and Drug Law Access blog post here for information on how FDA evaluates whether ingredients in liquid products meet FDA food additive requirements. FDA’s release of the two related guidance documents this week suggests that liquid products can expect to receive more intense regulatory scrutiny as a result of FDA enforcement priorities. Companies that market liquid products should carefully consider the new FDA guidance in determining whether their products qualify as liquid dietary supplements versus beverages, and ensuring that product formulations and labeling comply with the requirements that apply to products in the respective category.