Food and Drug Law Access

Not So Happy Meals? New York City Council Moves to Ban Free Toys Offered with Certain Food and Beverage Products

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

The New York City Council introduced a bill last week that would prohibit restaurants from offering free toys or other giveaways aimed at children in connection with certain meals and food and beverage products. The legislation would only permit restaurants to offer “incentive items” if the meal, food or beverage which with the item is offered meets specified nutritional criteria. “Incentive item” is defined to include any toy, game, trading card, admission ticket or other consumer product with particular appeal to children, whether offered directly by the restaurant or indirectly through a coupon or voucher.

The legislation seeks to indirectly influence the types of food and beverage products that would be offered to children. For example, a restaurant would be prohibited from offering any giveaway aimed at children in combination with the purchase of a meal unless the meal has less than 500 calories, less than 600 milligrams of sodium, less than 35% of total calories from fat, with certain exceptions, less than 10% of total calories from added sugars and caloric sweeteners. Additionally, the meal would be required to contain at least one half cup of fruit or vegetables or one serving of whole-grain products. Similar nutritional criteria are set forth for single food and beverage items.

The Board of Supervisors for Santa Clara County, California passed a similar ordinance in May 2010, which we discussed as part of a client advisory here. The city of San Francisco has also enacted a similar ordinance.

Sysco Agrees to Pay $19.4M to Settle California Enforcement Challenging the Company’s Food Safety Practices and Related Public Statements

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

The world’s largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve allegations that the company had engaged in unlawful food transportation and storage practices and had misrepresented its practices on the company’s website. 

The Department alleged that the company held “perishable food and other food products, including, but not limited to, dairy products, meats, poultry, frozen foods, seafood, canned food, dry food, produce, and beverages, in at least 22 unregistered public storage units” that lacked adequate temperature and sanitation controls. The Department further alleged that company’s employees were permitted “to transport perishable food and other food products from…unregistered sites to their customers in personal (non-commercial) vehicles without proper refrigeration during transportation, and under circumstances exposing such food to the risk of contamination.”  The Department alleged that the company had unlawfully mischaracterized its food safety practices on its website by characterizing the company’s commitment to “maintaining the most stringent standards in terms of food quality, consistency and food safety” and “providing the highest quality products,” and ensuring that its “state-of-the art distribution warehouses maintain the highest standards, often above and beyond government regulations.”

Notably, the complaint in the case alleged violations of the California’s Sherman Food, Drug, and Cosmetic Law (“little-FDCA”) and state consumer protection laws, seeking to enjoin the company from engaging in food safety violations, unfair and unlawful business practices, and false advertising. In an unsettling move by the state, the Department alleges that the statements made on the company’s website concerning food safety and quality were untrue and misleading, giving rise to violations under California law as false advertising. The Department’s complaint also illustrates how little-FDCAs and state unfair and deceptive practices laws can work together to enjoin food safety violations.

As part of the settlement, the company agreed to pay a total of $19.4 million, which includes a payment of $15 million in civil penalties.  The remaining settlement includes a $1 million food contribution to food banks throughout the state and $3.3 million to fund a 5 year state-wide-program aimed at helping help inspectors enforce food transportation laws.  Sysco is also required to develop a comprehensive food safety program to ensure that these practices are not repeated.

Notably, FDA currently is developing regulations that will impose more comprehensive food safety requirements on food distributors and transporters under the recent amendments to the  Federal Food, Drug, and Cosmetic Act (FDCA), which were made by the FDA Food Safety Modernization Act and Sanitary Food Transportation Act. FDA issued proposed regulations last year on concerning Hazard Analysis Risk Based Preventive Controls and Sanitary Transportation of Human and Animal Food.  The final regulations are scheduled for publication in August 2015 and March 2016, respectively. 

This historic settlement is a sobering reminder that as FDA continues its work to develop regulations implementing FSMA and SFTA, states have many enforcement tools under existing law which are available to address safety concerns related to food transportation and storage practices.


Posted in Cosmetics, Dietary Supplements, Drugs, FDA, Foods and Beverages, Regulation

A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular).” For this stance, FDA cited Section 230 of the Communications Decency Act, which has been interpreted as protecting websites owners from liability, in many areas, for the posts of others. Section 230 applies equally to drug and device companies, as well as dietary supplement, food, and other types of companies. Thus, FDA presumably should treat UGC on companies’ social media pages the same no matter what kind of product is being promoted. Not all past FDA warning letters, though, have appeared consistent with Section 230.  See, e.g., Origin BioMed warning letter.  

The FDA’s recent warning letter, however, is consistent with Section 230 and may signal that FDA offices are adopting a uniform approach to UGC. The recent letter was addressed to a company that sells cough syrups and sleep remedies as foods. FDA alleged that certain claims for the products were disease claims and, thus, converted the products into unapproved drugs. FDA pointed to Facebook and Twitter comments by consumers on the company’s social media pages, but only if the company had either “liked” or otherwise endorsed the comments through responses (e.g., “Mary, thank you for writing this!!! We love to hear that we have helped people”). It appears that by virtue of the “likes” and responses, FDA no longer considered the consumer comments truly independent. It remains to be seen whether FDA will stay the course and remain consistent in its future enforcement efforts against products other than drugs or medical devices.

Potential for Delays at West Coast Ports As Labor Negotiations Continue

Posted in Imports/Exports

Importers and exporters are to be advised of potential delays at many West Coast ports caused by ongoing contract negotiations between International Longshore and Warehouse Union (ILWU) and the Pacific Maritime Association (PMA).   Negotiations between the union and association will resume tomorrow, July 11, but U.S. importers and exporters are urged to develop contingency plans in the event of a strike or lockout at West Coast ports.

These plans should include:

  • Prioritizing orders
  • Organizing distribution centers to secure change in inventories
  • Preparing to change routes to East and Gulf coast ports and locking in rates with carriers
  • Securing ground transportation
  • Potentially using air freight or a combination of sea-air

U.S. Customs and Border Protection has updated its guidelines for ship and cargo contingency plans in the event of any West Coast port disruption.  For more information, please click here.

FDA Releases Social Media Guidance for Promotion of Prescription Drug and Medical Device Products

Posted in Drugs, FDA, Medical Devices

Recently, FDA released two draft guidance documents on the promotion of prescription drugs and medical devices on the Internet and social media platforms.  The long-awaited guidance provides recommendations for firms that choose to correct misinformation disseminated by independent third parties and to promote their products on space-constrained platforms, such as Twitter or sponsored ads.  Comments on the guidance documents are due by September 15, 2014.

Correcting Misinformation

The first guidance document – Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices – describes how FDA believes manufacturers, packers, and distributors of prescription drugs and medical devices should respond to misinformation (either positive or negative) about their products disseminated by independent third parties, either on the firm’s website(s) or social media accounts or those of a third party.  The guidance applies only to third-party communications for which the firm is not responsible, which may include firm-hosted discussions – in which the firm does not participate – about its products, as long as those discussions include a clear and conspicuous statement that the firm did not create or control the user-generated content.

A firm is not required to correct misinformation created or disseminated by an independent third party who is not under the firm’s control or influence, but, if it chooses to do so, FDA recommends that the firm provide appropriate corrective information that:

  • Is relevant and responsive to the misinformation;
  • Is limited and tailored to the misinformation;
  • Is non-promotional in nature, tone, and presentation;
  • Is accurate;
  • Is consistent with the product’s FDA-required labeling;
  • Is supported by sufficient evidence (including substantial evidence, when appropriate);
  • Either is posted in conjunction with the misinformation in the same area or forum, or references the misinformation and is intended to be posted in conjunction with it; and
  • Discloses that the person providing the corrective information is affiliated with the firm.

Additionally, the firm should provide the FDA-required labeling (or a link thereto).  The firm is not required to correct all misinformation on a given blog or forum but, if it chooses to correct any misinformation, should clearly identify the misinformation it is correcting.  The firm should also address all misinformation in a given comment or portion of a website.  Finally, while FDA does not expect the firm to submit corrections to the Agency for review, the firm should maintain records of the misinformation (content, date/location of appearance) and subsequent correction.

Presenting Information with Character Space Limitations

The second guidance document – Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices – describes how firms that choose to present benefit and risk information on platforms with space constraints, such as via online microblog messaging or online paid searches, should do so.  In general, promotional information must include both the benefit and risk information in the same space-constrained communication, and FDA recommends that firms evaluate whether a space-constrained platform is the best promotional tool for a particular product.

If a firm decides to promote its product on a space-constrained platform, having concluded that adequate benefit and risk information and any required information can be communicated within the space constraints, FDA recommends that the benefit information be accurate and non-misleading and reveal material facts within each individual communication.  Because the accompanying risk information should be comparable in scope to the benefit information, the firm should consider whether the risk information qualifies any representations made about the product and is presented with comparable prominence and readability.  Additionally, the content of the risk information should, at a minimum, include the most serious risks (e.g., fatal or life-threatening risks and contraindications) and a direct hyperlink to a more complete discussion of risk information.

Finally, FDA also recommends that firms consider FDCA requirements that, in advertising, the trade or brand name accompany the established name and that the advertisement prominently display the name of at least one specific dosage form in conjunction with the quantitative ingredient information.


Kelley Drye Offers Webinar on “Hot Topics in Social Media” July 9 at 2 PM

Posted in Uncategorized

Social media is a powerful marketing tool. It’s personal, dynamic, and reaches an unlimited number of consumers. But, the value of social media can be tempered by the legal risks. Both the Federal Trade Commission and the Food and Drug Administration have been paying close attention to social media activities by dietary supplement companies and have brought numerous enforcement actions involving social media. Understanding the legal framework and social media practices that could leave your company vulnerable to regulatory action is critical to any marketing plan.

To learn more about using social media in the current regulatory environment, please join Kelley Drye for a free webinar presentation on July 9, 2014 from 2 to 3 pm ET. Click Here to Register.

Some of the questions we will be answering are:

  • What steps should your company take to mitigate risks in using social media in its marketing?
  • What steps should your company take if it engages consumers on social media pages?
  • How can companies mitigate legal risks associated with consumer-generated content?
  • What do the FDA’s new social media guidance documents mean for dietary supplement companies?
  • How do recent FDA and FTC actions affect social media practices?

Kelley Drye Speakers:

Katie Bond,  Associate, Advertising and Marketing Practice Group
Megan Olsen,
Associate, Advertising and Marketing Practice Group

Council for Responsible Nutrition Speakers:

Rend Al-Mondhiry, Regulatory Counsel

This webinar is free of charge. Presentation slides and a recording of the webinar will be available to registrants. Click Here to Register.

FDA Issues Long-Awaited Proposed “Deeming” Regulations for Tobacco Products

Posted in FDA, Regulation

The FDA today released a proposed rule that would “deem” certain products meeting the statutory definition of “tobacco product” to be subject to regulation as a tobacco product under the Family Smoking Prevention and Tobacco Control Act. In so doing, the proposed rule would extend FDA’s authority to products currently unregulated by the agency such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables.

The FDA proposed two options as possible approaches to subjecting certain presently unregulated products to FDA jurisdiction. Under the first option, FDA would deem all products that meet the definition of “tobacco product” under the law to be subject to regulation except accessories (e.g., hookah tongs, bags, cases, charcoal burners and holders). Under the second approach, FDA would not deem certain “premium cigars” to be subject to regulation because “it has been suggested that different kinds of cigars may have the potential for varying effects on public health.”

In addition to seeking information on the potential varying public health effects of cigars, FDA also sought information regarding, among other issues:

  • Whether e-cigarettes should be subject to the prohibition against characterizing flavors;
  • Behavioral data showing any correlation between the use of e-cigarettes and the use of traditional tobacco products;
  • Whether all tobacco products should be required to carry an addiction warning.

The proposed rule is scheduled to be published tomorrow in the Federal Register and will thereafter be open for public comment for 75 days.

FDA Seeks Comment On New Consumer Reporting Requirements Under FSMA

Posted in FDA

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.

FDA Releases Draft Guidance on Proper Labeling of Honey and Honey Products

Posted in FDA, Foods and Beverages, Imports/Exports

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.

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.