Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 8

Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 8

Read the Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 8 newsletter.


April 21, 2015: Chris Mikson is moderating a panel titled "The Future of Biosimilars" at a plenary session of the Food and Drug Law Institute (FDLI) Annual Conference in Washington, D.C. The panel will discuss recent developments in FDA regulation of biosimilars and what to expect as the field continues to evolve.

May 3–5, 2015: Scott Edelstein and Alexis Gilroy will speak at the American Telemedicine Association's Annual Meeting in a program titled "Telehealth Partnering in US & Abroad—A Look at Viable Strategies & Legal Considerations." Doug Pearson, Bruce Olcott, and Chris Mikson will speak at a pre-conference session titled "Digital Health in Transition: Regulatory Insight for Product Developers."

Top News

FDA Proposes Amendments to Food Facility Registration Regulation
FDA recently published a proposal to amend its regulation on registration of food facilities. The current regulation requires food facilities that manufacture/process, pack, or hold food for consumption in the United States to register with FDA. However, exemptions exist for "retail food establishments," defined as an establishment that sells food products directly to consumers as its primary function. The proposed rule would update the definition to expand the number of establishments that meet that definition and are therefore not required to register with FDA or comply with the requirements of the Food Safety Modernization Act ("FSMA"). The proposed rule clarifies that roadside stands, farmers' markets, Community Supported Agriculture programs, and other direct-to-consumer sales platforms would also be included in the definition. For facilities not exempt from registration, the proposed rule codifies certain administrative provisions of FSMA, such as email contact, biannual registration, allowance for inspections, and improvements to the food facility registration system. FDA is currently accepting public comments to the docket

State AGs Ask Congress to Investigate the Herbal Supplements Industry
A group of 14 state attorneys general ("AGs"), led by the New York AG, has asked Congress to investigate the herbal supplements industry. As reported in a previous Jones Day Update, the New York AG recently conducted an investigation and announced the formation of a coalition with several state attorneys for an expanded probe of herbal supplement business practices. The group of AGs has now sent a letter asking Congress to give FDA more control over herbal supplements. The Council for Responsible Nutrition, a major dietary supplement trade association, responded by saying that allegations of widespread safety issues are untrue and explained that the government's post-market surveillance system demonstrates that there are relatively few safety issues with regard to these products.

FDA Requests Comments Help Update Redbook
FDA is requesting comments from industry to help continue the process of updating its guidance on food ingredient safety assessment, commonly known as the "Redbook." Formally known as Toxicological Principles for the Safety Assessment of Food Ingredients, FDA's Redbook was originally published in the 1980s as guidance to industry and other stakeholders regarding the information FDA's Center for Food Safety and Applied Nutrition ("CFSAN") used to evaluate the safety of food and color additives during the premarket review process. FDA intends to update the Redbook to design a framework incorporating the assessment of ingredients present in various products regulated by CFSAN. FDA is particularly interested in comments on the scope, manner, and methods to use in the review, ways to make the guidance clearer and more useful to industry, and key studies, considerations for study interpretation, assays, test methods, and endpoints that could be useful for safety assessment.

FDA Announces Strategy to Review Animal Food Ingredients
Late last month, FDA announced its strategy to create definitions and standards of animal food ingredients in order to increase transparency and affirm the safety of the animal food supply. FDA will review the animal food ingredients definitions contained in the Official Publication of the Association of American Feed Control Officials ("AAFCO"), a voluntary organization that provides a forum for regulatory officials to provide guidance and recommendations to ensure uniformity of regulation of animal feeds from state to state. The Official Publication includes FDA-approved food additives and ingredients that are generally recognized as safe ("GRAS"), as well as AAFCO-established definitions for other ingredients. FDA intends to align AAFCO ingredient listings with the agency's regulatory process and requirements. FDA plans to publish a proposed rule for animal food ingredients that are approved food additives or GRAS by the agency. For remaining ingredients, FDA's scientists will conduct a review and categorize them as GRAS or food additives, and if the ingredient falls outside these categories, manufacturers will be allowed to file petitions with FDA.

The European Commission Prepares Reform of GMO Imports
The European Commission has announced plans to present a new legal framework for the authorization of GMO imports into the EU by the end of April 2015. The new legislation is expected to follow the approach that was adopted for cultivation of GMOs and allow EU Member States to prohibit, within their territory, marketing of products that contain EU-authorized GMOs or that are derived from those GMOs. 

Other News
WTO Pauses Deliberations Over Private Food Standards for "Cooling-off" Period

USDA Discloses Pork and Beef Trade Pacts with Peru and Mexico 

EU Expands COOL Meat Requirements Beyond Beef

Grocers, Seed Growers, and Consumer and Environmental Advocates Challenge USDA Organic Rule Change in Federal Court

Regulatory Updates

FDA Proposes to Amend Regulations for Registration of Food Facilities
In the April 9, 2015, Federal Register, FDA announced its proposal to amend regulations for registration of foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States. The proposed amendments will enhance FDA's capabilities to respond to food safety issues and will provide FDA with more information that they can use to focus and better utilize limited inspection resources. Comments are due June 8, 2015.

USDA Solicits Nominations for National Organic Standards Board
In the April 9, 2015, Federal Register, USDA requested nominations to fill five upcoming vacancies on the National Organic Standards Board ("NOSB"). The NOSB was established to assist in the development of standards for substances to be used in organic production and to advise the Secretary of Agriculture on the implementation of the Organic Foods Production Act of 1990. The Secretary will appoint one person to each of these five positions to serve a five-year term of office that will commence on January 24, 2016, and end January 23, 2021. Nominations are due May 15, 2015.

HHS and USDA Extend Comment Period for 2015 Dietary Guidelines Advisory Committee Report
In the April 8, 2015, Federal Register, HHS and USDA announced the extension of the comment period for the Scientific Report of the 2015 Dietary Guidelines Advisory Committee ("Advisory Report"). As announced in the February 23, 2015, Federal Register, the original deadline for comments on the Advisory Report was April 8, 2015. See a previous Jones Day Commentary for more details on the Advisory Report. Comments on the Advisory Report are now due May 8, 2015.

FDA Requests Nominations for Individuals and Consumer Organizations for Advisory Committees
In the April 3, 2015, Federal Register, FDA announced that it is requesting any consumer organizations to notify FDA if they are interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels with current vacancies or vacancies expected to occur in the near future. Interest letters and nominations must be submitted by May 4, 2015.

AMS Announces Rate Changes for 2015
In the April 9, 2015, Federal Register, USDA's Agricultural Marketing Service ("AMS") announced the 2015 rates it will charge voluntary grading, inspection, certification, auditing, and laboratory services for a variety of agricultural commodities including meat and poultry, fruits and vegetables, eggs, dairy products, and cotton and tobacco. The 2015 regular, overtime, holiday, and laboratory services rates will be applied at the beginning of the crop year, fiscal year, or as required by law, depending on the commodity.

USDA Gives Notice of Intent to Renew Trade Policies and Requests Nominations for FAS Committees
In the April 6, 2015, Federal Register, USDA's Foreign Agricultural Service ("FAS") gave notice that USDA, in coordination with the U.S. Trade Representative, intends to review the Agricultural Policy Advisory Committee ("APAC") for Trade and the six Agricultural Technical Advisory Committees ("ATACs") for Trade. FAS also requests nominations for persons to serve on these seven committees for four-year terms. Among other matters arising from the administration of U.S. trade policy, the APAC provides advice on the operation of various existing U.S. trade agreements and on negotiating objectives for new trade agreements. The ATACs draw upon the technical expertise of its members to provide advice and information on trade issues affecting both domestic and foreign production in the commodities of the sector. In the April 10, 2015, Federal Register, FAS published an updated notice correcting four minor errors in the original notice. Nominations are due April 30, 2015.

CCC Invites Proposals for Funding Awards for Five Agricultural Programs
In the April 7, 2015, Federal Register, USDA's Commodity Credit Corporation ("CCC") announced that it is inviting proposals for the 2016 Foreign Market Development Cooperator ("Cooperator") program, the 2016 Market Access Program ("MAP"), the 2016 Emerging Markets Program ("EMP"), the 2016 Quality Samples Program ("QSP"), and the 2016 Technical Assistance for Specialty Crops ("TASC") program. All programs are administered by FAS. The Cooperator program and MAP help develop foreign markets for U.S. products through cost-share assistance. EMP helps develop exports of U.S. products by funding improvements to emerging markets' business systems, thereby reducing potential trade barriers. QSP helps develop export markets for U.S. products by assisting U.S. entities in providing commodity samples to potential foreign importers. The TASC program provides funding for projects that address sanitary, phytosanitary, or technical barriers that prohibit or threaten the export of U.S. specialty crops. The announcements solicit applications from eligible applicants for fiscal year 2016 and invite proposals for establishing criteria for awarding funds under the programs in October 2015. Applications for all programs are due June 8, 2015.

Other USDA Announcements

  • Food and Nutrition Service ("FNS") Announces Adjusted Income Eligibility Guidelines for Special Supplemental Nutrition Program for Women, Infants, and Children
  • FNS Announces Annual Adjustments to Income Eligibility Guidelines to Determine Eligibility for Child Nutrition Programs
  • AMS Issues Proposed Rule to Implement Recommendation on Increased Assessment Rate for Grapes Grown in Designated Area of Southeastern California
  • AMS Issues Interim Rule Continuing Previous Suspension of Marketing Order Regulating Handling of Irish Potatoes Grown in Southeastern States
  • AMS Issues Proposed Rule to Amend Procedures for Sign-up Period for Cotton Research and Promotion Program

USDA Announced Its Intent to Request Approval to Establish the Following New Information Collections

  • Small Business Innovation Research Program

USDA Announced the Following Requests for Information

  • National Woodland Owner Survey

USDA Announced the Following Proposed Information Collections

  • National Universal Product Code Database
  • SuperTracker Information Collection for Registration, Login, and Food Intake and Physical Activity Assessment Information

USDA Announced the Following Information Collections Have Been Revised and/or Extended

  • School Breakfast Program
  • Understanding Value Trade-offs Regarding Fire Hazard Reduction Programs in the Wildland-Urban Interface
  • Supplemental Nutrition Assistance Program, Request for Administrative Review; Food Retailers and Wholesalers

USDA Announced Its Intent to Renew and/or Extend the Following Information Collections

  • Civil Rights Compliance Review Record—Federally Assisted Programs
  • Community Forest and Open Space Program

FDA Announced the Opportunity to Comment on the Following Proposed Information Collections

  • Irradiation in the Production, Processing, and Handling of Food
  • Declaration of Certifiable Color Additives

FDA Announced that the Following Collections Have Been Approved by OMB

  • Calorie Labeling of Articles of Food in Vending Machines
  • Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

European Regulatory Updates

NGO Confronts FDA, EFSA, and ECHA over BPA
The Brussels-based NGO Rebutting Industry's Science with Knowledge ("RISK") alleges that a 2008 two-generation study of mice, which claimed to show no low-dose reproductive effects of bisphenol A ("BPA"), is flawed. This study is widely used to support the safety of BPA by FDA, the European Food Safety Authority ("EFSA"), and the European Chemicals Agency ("ECHA").

EU Ends Milk Quotas
On March 31, 2015, the EU milk quota regime came to an end. Milk quotas were introduced to address the structural oversupply on the EU market of the late 1970s and early 1980s. EU dairy farmers were guaranteed a price for their milk (considerably higher than on world markets) regardless of market demand.

Monitoring Results on Residues of Oxadixyl in Food Products
On March 26, 2015, EFSA published a compilation of the monitoring results regarding residues of the pesticide oxadixyl in foods in the EU.

European Commission Authorizes a Health Claim on Cocoa Flavanols
On March 31, 2015, the European Commission issued Commission Regulation (EU) 2015/539 authorizing the following health claim: "Cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow."

European Commission Authorizes Oil from Micro-Algae Schizochytrium as a Novel Food Ingredient
On March 31, 2015, the European Commission issued Commission Regulation (EU) 2015/545 authorizing the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97.

Upcoming Meetings, Workshops, and Conferences

Beginning Farmers and Ranchers Advisory Committee Meeting, April 17, 2015, via teleconference. 

FDA-JIFSAN Dietetics and Nutrition Spring Webinar Series, April 20, 2015, via webcast.

USDA Agricultural Air Quality Task Force Meeting, April 22–23, 2015, in Knoxville, TN.

FDA FSMA Implementation Strategy Meeting, April 23–24, 2015, in Washington, D.C.

FDA Public Workshop: The 2015 Office of Regulatory Science and Innovation Science Symposium, April 27, 2015, in Silver Spring, MD.

National Agricultural Research, Extension, Education, and Economics Advisory Board Meeting, April 27–29, 2015, in Washington, D.C.

National Organic Standards Board Meeting, April 27–30, 2015, in La Jolla, CA.

FDA and AFDO Conference titled In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation, June 20–24, 2015, in Indianapolis, IN.

EFSA's 2nd Scientific Conference, October 14, 2015, in Milan, Italy.

Enforcement Updates

Recent Product Recalls
Recent food recalls involved undeclared ingredients, potential microbial contamination, and metal contamination, among others.

Undeclared allergens continue to be a major trigger of food recalls, with more than 15 manufacturers recalling FDA-regulated products for this reason alone since we last reported on recalls in March 2015. The undeclared ingredients included milk, soy, peanuts, hazelnuts, walnuts, eggs, sulfites, and wheat. USDA also reported several recalls for this reason (see below). 

Microbial contamination accounted for more than 20 recalls since our March 2015 issue. Frozen ravioli, ice cream, sorbet, soybean sprouts, spinach and various spinach products, assorted frozen meals, macadamia nuts, walnuts, trail mixes, mixed nuts, coconut products, garlic powder, and various products made with garlic powder were recalled for being potentially contaminated with Salmonella or Listeria. In addition, macaroni and cheese products were recalled for possible metal pieces. 

USDA also reported several recent recalls involving undeclared allergens in pork, beef, and chicken products. Other USDA-regulated product recalls included beef and pork jerky products for Listeria contamination and roast beef, beef, goat, lamb, pork, and chicken products for misbranding. Finally, beef, corned beef, chicken, pork, goat, and lamb products were recalled for lack of import inspection.

View a complete list of product recalls for FDA-regulated products and USDA-regulated products.

Recent Warning Letters
Since we last reported on enforcement actions in March 2015, FDA posted warning letters to seafood processors, juice processors, dairies, and other food companies or violations related to CGMP (current good manufacturing practice), commodity-specific regulations, labeling, illegal drug residues, unapproved drug claims, and cosmetics, among others.

FDA warned two juice manufacturers for failing to comply with juice hazard analysis and critical control points regulations, for CGMP violations, and for insanitary conditions. Three seafood processing facilities were cited for failing to comply with hazard analysis and critical control points regulations and for various CGMP violations, and two of the facilities were additionally warned for processing seafood in insanitary conditions. FDA also warned two dairy farms for selling cattle adulterated with illegal drug residue for slaughter. One acidified foods manufacturer, located overseas, was warned for various violations of the Acidified Foods and Emergency Permit regulations. 

FDA continues to review product labels for incorrect or incomplete claims. FDA cited a Japanese manufacturer of soy sauce for improperly formatted nutrition information and failure to use the common or usual name of ingredients on the label. An American cereal manufacturer was cited for bearing an unauthorized health claim related to whole grains. 

FDA cited only two dietary supplement manufacturers since our March 2015 issue. One manufacturer of eye care products was warned for marketing unapproved drugs because its product is promoted for therapeutic claims. Another manufacturer was warned for using melatonin, an unsafe food additive, in a beverage product that was improperly marketed as a dietary supplement. 

Finally, in a rare warning letter to a cosmetics manufacturer, FDA warned a skin care products manufacturer that therapeutic claims on its website rendered the products unapproved new drugs.

View FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).

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