Food and Drug Law Access

FDA Holds Hearing on OTC Drug Review Process; Accepting Comments Until May 12

Posted in Drugs, FDA

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.


Taking Advantage of the Korea-U.S. Free Trade Agreement

Posted in Imports/Exports

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.;[1] 2) The goods must qualify under the rules of origin;[2] 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.

[1]           An exception is for unloading and reloading in a third country, but it must be done under Customs control.

[2]           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.

FDA Proposes to Revamp Nutrition Labeling Requirements for Conventional Foods and Dietary Supplements

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

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

FDA Proposes Significant Changes to RACCs and Serving Size Requirements

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

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

FDA Reopens Comment Period on Final Guidance Requiring INDs for Certain Food, Dietary Supplement, and Cosmetic Studies

Posted in Cosmetics, Dietary Supplements, Enforcement, FDA, Foods and Beverages

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.

FDA To Increase Civil Money Penalty Amounts

Posted in FDA, Regulation

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 Releases Long-Awaited Proposed Rule Prescribing Sanitary Transportation Practices for Human and Animal Food

Posted in FDA, Foods and Beverages, Regulation

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.

Is it a Beverage or Liquid Dietary Supplement? FDA Issues Final Guidance to Help Companies Tell the Important Difference

Posted in Dietary Supplements, FDA, Product Labeling & Marketing

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.


FDA Publishes Guidance on Food, Beverage, and Dietary Supplement Additives

Posted in Dietary Supplements, FDA, Foods and Beverages, Product Safety

On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same requirements apply to certain substances – i.e., non-dietary ingredients – added to dietary supplements. According to FDA, the document was spurred by the growth of food and beverage products that contain novel substances, such as added botanical ingredients or their extracts, that may be unapproved food additives, or contain additives in excess of their traditional use levels.

The guidance reiterates the requirements for additives in conventional foods: if a substance is not generally recognized as safe (“GRAS”) for its intended use in food, it is a food additive that must receive premarket approval before it can be used. The use of an unapproved food additive will render a food or beverage adulterated. FDA is concerned, however, that the new substances added to conventional foods and beverages are not GRAS for their intended use and are not being used in accordance with a food additive regulation. Additionally, the use of traditional substances at much higher levels and in new types of foods may not be safe.

The guidance also emphasizes that, although dietary ingredients used in dietary supplements are exempt from the food additive definition (and requirements), other, non-dietary ingredients such as binders and fillers are not exempt, and must be used in accordance with a food additive regulation or be GRAS for their intended use.

FDA Issues Proposed Rule to Combat Intentional Adulteration under FSMA

Posted in FDA, Foods and Beverages, Regulation

FDA recently issued a new proposed rule under the Food Safety Modernization Act (FSMA) that would require domestic and foreign food facilities to identify and implement focused mitigation strategies to reduce the risk of intentional adulteration. The rule is scheduled to be published tomorrow in the Federal Register and interested parties will have until March 21, 2014 to submit comments.

Under the proposed rule, non-exempt food facilities would be required to prepare and implement a written food defense plan, including actionable process steps, focused mitigation strategies, procedures for monitoring, corrective actions and verification. Based on results of vulnerability assessments conducted using the CARVER+Shock methodology, the proposed rule identifies four categories of “key activity types,” which result in a facility being considered at a high risk for intentional adulteration. Those activity types are bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities.

The key activity types are intended to serve as a guide, though not a replacement for, a facility’s vulnerability assessment. As with other proposed rules implementing FSMA, the rule proposes staggered compliance dates based on the size of the facility – ranging from one to three years from publication of the final rule.

The proposed intentional adulteration rule is the sixth proposed rule by FDA implementing FSMA. We will continue to monitor developments regarding this and other FSMA rules here.