Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 6
FSMA Funding Needed to Fill Gaps, Says FDA Commissioner to Senate Budget Committee
During a Senate budget hearing last week, FDA Commissioner Margaret Hamburg stressed the need for a total of $1.5B for food safety and nutrition for fiscal year 2016, including significant funds increase to implement the Food Safety Modernization Act ("FSMA"). Hamburg explained that the additional funding is necessary to implement the major elements of FSMA, and that a budget shortfall will undermine Congress's intent to transform the U.S. food safety system. Specifically, Hamburg said that the funding is important for modernizing inspections and staff training, providing guidance and technical assistance, working with states, and raising the level of oversight abroad. During the hearing, Hamburg also fielded questions regarding irrigation water, funding allocations for research conducted by FDA's Center for Food Safety and Applied Nutrition, and FDA's plans to involve USDA in implementing FSMA. Hamburg also reiterated that although the budget request is sizable in comparison to previous requests, it was not excessive in terms of what the Agency needs to fulfill its duties.
Led by New York, State AGs Investigate Herbal Supplements
In early February 2015, the New York State attorney general's office announced a major investigation into certain herbal supplement products and called upon retailers to pull these products from store shelves until the ingredients could be verified. Last week, in what appears to be a continuation of these efforts, the New York AG announced that several state attorneys general had formed a coalition for an "expanded probe" to "further investigate the business practices of the herbal supplement industry." Along those lines, more than 50 class actions have been filed in the past month that accuse the retailers of fraud through the sale of the supplements. Although supplements are regulated by FDA, the extent of that regulation has often been controversial, and state authorities may exercise their consumer protection authority to fill what some perceive as a gap in regulation. The Council for Responsible Nutrition, a major dietary supplement trade association, has called the New York AG's investigation "uninformed, reckless, and inexcusable" and responded with a host of resources that explain why the DNA testing method relied upon by the New York AG is inappropriate for determining the content of dietary supplements, and therefore cannot be trusted for accurate or reliable account of the content of an herbal dietary supplement.
FDA Issues Menu Labeling Guidance
FDA has issued a guidance for industry called Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments—Small Entity Compliance Guide. The guidance, in a question-and-answer format, sets forth in plain language the requirements embodied in the Agency's recent final rule, "Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments," which becomes effective December 1, 2015. FDA is in the process of developing a similar compliance guide for small businesses for vending machine labeling, which it plans to issue soon.
FDA, EPA to Share Data on Pesticides and Toxic Substances
FDA and the U.S. Environmental Protection Agency ("EPA") recently announced a Memorandum of Understanding ("MOU") between the two agencies to share data on pesticides, which will allow both agencies to better assess risks to the public and the environment. Whereas FDA is responsible for ensuring the safety of food, animal drugs, and cosmetics under the Federal Food, Drug, and Cosmetic Act ("FDCA") and other laws, EPA is responsible for managing the pesticides and toxic substances programs pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), the FDCA, and the Toxic Substances Control Act ("TSCA"). Some substances may be regulated by both agencies. The MOU establishes a policy of disclosure and sharing of each agency's respective databases that will facilitate the agencies' decisions related to food safety, veterinary medicine, and cosmetics.
USDA Withdraws Proposed Biotech Rule
USDA's Animal and Plant Health Inspection Service ("APHIS") formally withdrew a six-year-old proposed rule that would have changed the federal government's approach toward agricultural biotechnology. If it had been finalized, the proposed rule would have been the first comprehensive update of APHIS's biotechnology regulatory regime since 1987. The proposed rule attempted to improve the regulatory processes by taking modern genetic engineering technology into account, but APHIS had taken no action on the proposed rule since holding two public meetings in 2009. According to a fact sheet posted on its website, APHIS is reconsidering its approach to the issue in response to 88,300 comments on the proposal, many of which expressed concerns about a lack of detail and clarity about APHIS's role in biotech regulation. APHIS now plans to "utilize an open and robust dialogue to drive the development of future regulatory or policy approaches." This dialogue will begin with a series of webinars that will be announced soon.
FDA's Milk Sampling Survey Finds 99% of Samples Free of Drug Residue
FDA recently announced the results from its milk sampling survey, which tested milk from nearly 2,000 dairy farms for drug residues. The Agency was investigating whether dairy farms with previous drug residue violations were more likely to have drug residues in milk compared to dairy farms with no previous violations. By comparing samples from farms with previous violations to a control group, the survey found that more than 99 percent of the samples were free of concerning drug residues. FDA is pointing to the survey as evidence of the overall safety of the U.S. milk supply and, in particular, that the U.S. milk safety system effectively prevents drug residues of concern in milk, even in those instances when medications are needed for the health of the dairy cattle. FDA pledges that it intends to maintain a strong system to ensure milk safety, including working with state regulators, updating the milk safety program, increasing testing, and educating dairy producers.
FDA Announces the Filing of Two Food Additive Petitions
In the March 16, 2015, Federal Register, FDA announced the filing of two food additive petitions, submitted by the Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Children's Environmental Health Network, Center for Science in the Public Interest, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment. The first Federal Register notice, filed on December 31, 2014, proposed that FDA amend its regulation to (i) no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers; (ii) revoke the exemption for use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods, and (iii) issue a new regulation to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. FDA is seeking comments on the first petition. The second Federal Register notice, filed on January 7, 2015, proposed that the Agency amend its regulations to no longer provide for the use of three specific perfluoroalkyl ethyl-containing food contact substances as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. Comments on the first petition are due May 15, 2015.
APHIS Withdraws Proposed Rule on Biotechnology
In the March 4, 2015, Federal Register, USDA's APHIS withdrew an October 9, 2008, proposed rule that would have changed the federal government's approach toward agricultural biotechnology. APHIS is withdrawing the rule in light of continuing advances in biotechnology and comments received on the rule. APHIS intends to engage new stakeholders in an effort to explore alternative policy approaches, beginning with a series of webinars that will allow stakeholders to provide initial feedback. Information on these webinars will be announced soon.
USDA Announces Intent to Reestablish Biotechnology Advisory Committee
In the February 27, 2015, Federal Register, USDA announced its intent to reestablish the Advisory Committee on Biotechnology and 21st Century Agriculture ("AC21") for a two-year period. The purpose of the AC21 is to examine the long-term impacts of biotechnology on the U.S. food and agricultural system and USDA, and to provide guidance to USDA on pressing individual issues related to the application of biotechnology on agriculture. The AC21 will meet up to four times per year in Washington, D.C.
APHIS Solicits Public Comment on List of Threats to Animal or Plant Health
In the February 27, 2015, Federal Register, USDA's APHIS announced the solicitation of public comments regarding the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Agricultural Bioterrorism Protection Act of 2002 requires the biennial review and publication of the list of select agents and toxins, and revision of the list as necessary. APHIS is seeking public comment on the current list and will also accept suggestions regarding additions or reductions of pathogens on the list. Comments are due April 28, 2015.
AMS Solicits Nominees for National Organic Program Task Force
In the March 9, 2015, Federal Register, USDA's Agricultural Marketing Service ("AMS") solicited nominees to participate in a task force to examine the alignment of hydroponic and aquaponic practices with USDA organic regulations and the Organic Foods Production Act. The USDA organic regulations do not cover organic hydroponic or aquaponic production, but these production systems have obtained certification under the USDA organic regulations by complying with the existing regulations for organic crop production. The task force will inform the National Organic Standards Board of their findings and recommend what practices should be allowed or restricted in such production. Nominations are due May 8, 2015.
FNS Establishes Minimum Professional Standards for National School Lunch Program's School Nutrition Personnel
In the March 2, 2015, Federal Register, USDA's Food and Nutrition Service ("FNS") issued a final rule establishing minimum professional standards for school nutrition personnel who manage and operate the National School Lunch and School Breakfast Programs. The final rule institutes hiring standards for selecting state and local school nutrition program directors, and it requires all personnel in the school nutrition programs to complete annual continuing education and training. The rule is effective July 1, 2015.
FSIS Extends Comment Period for Proposed Changes to Salmonella and Campylobacter Verification Testing Program for Chicken and Turkey Products
In the March 10, 2015, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") announced the extension of the comment period for the verification testing program announced in the January 25, 2015, Federal Register. The initial notice requested comments on new pathogen reduction performance standards for Salmonella and Campylobacter in raw chicken parts and not-ready-to-eat comminuted chicken and turkey products. The notice also announced, among other things, plans to begin sampling raw chicken parts in March 2015 to gain additional information on the prevalence of the microbiological characteristics of the two pathogens. The extension is in response to a request made by a coalition of trade associations. Comments are now due May 26, 2015.
FSIS Extends Effective Date for New Foreign Inspection Certificate Requirements
In the March 12, 2015, Federal Register, USDA's FSIS announced the extension of the effective date for foreign inspection certificate requirements to ensure that countries have sufficient time to adjust to the new requirements. The final rule announcing the new requirements was published on September 19, 2014, and amended the meat, poultry, and egg products import regulations to provide for the Agency's Public Health Information System Import Component. Among other changes, the rule also removed from the regulations the discontinued "streamlined" import inspection procedures for Canadian products and required Sanitation Standard Operating Procedures at official import inspection establishments. The original effective date of the rule was November 18, 2014, but FSIS will now allow countries to continue under existing inspection certificates until March 18, 2015. The new compliance date is March 18, 2015.
Other USDA Announcements
- Farm Service Agency ("FSA") amends Biomass Crop Assistance Program regulations as required under 2014 Farm Bill
- APHIS Adds New Treatment Schedule for Methyl Bromide Fumigation of Figs for Internal Pests to Plant Protection and Quarantine Treatment Manual
- AMS Announces Renewal of the Plant Variety Protection Board Charter
- APHIS Issues Technical Amendment to Final Rule Concerning Importation of Live Birds and Poultry from Regions with Any Subtype of Highly Pathogenic Avian Influenza
- AMS Proposes Amendments to Regulation on Handling of Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida
- AMS Issues Proposed Rule on Relaxing Handling Requirements for California Table Grapes and Import of Table Grapes
- APHIS Issues Proposed Rule to Amend Regulations Governing Importation of Tomato Plantlets from Mexico
- APHIS Reopens Comment Period on Proposed Rule to Amend Regulations Governing Importation of Orchids from Taiwan
- APHIS Announces Availability of Pest Risk Analysis for Importation of Fresh Cranberries from Chile into the United States
- APHIS Amends Gypsy Moth Regulations by Adding Infested Areas in Minnesota, Virginia, West Virginia, and Wisconsin
USDA Announced the Following Requests for Information
- Gathering Sessions for Safe Food Handling Instructions
- Summer Meal Programs Data Reporting Requirements
USDA Announced the Following Proposed Information Collections
- Review of Child Nutrition Data and Analysis for Program Management
- WIC Participant and Program Characteristics Study
USDA Announced the Following Information Collections Have Been Revised and/or Extended
- Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
USDA Announced the Following Information Collections Have Been Submitted to OMB
- Regulations for the Inspection of Eggs
- Marking, Labeling, and Packaging of Meat, Poultry, and Egg Products
- Patent License Application
USDA Announced Its Intent to Reinstate the Following Previously Approved Information Collections
- Animal Disposition Reporting
FDA Announced the Opportunity to Comment on the Following Proposed Information Collections
- Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
FDA Announced the Following Information Collections Have Been Submitted to OMB
- Notification of a Health Claim or Nutrition Content Claim Based on an Authoritative Statement of a Scientific Body
- Substances Prohibited from Use in Animal Food or Feed
FDA Issued the Following Draft and Final Guidance Documents
Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments—Small Entity Compliance Guide. March 13, 2015, Federal Register.
Revised Final Guidance for Industry: Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods. March 9, 2015, Federal Register.
Revised Final Guidance for Industry: Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies. March 9, 2015, Federal Register.
European Regulatory Updates
European Commission Rejects Certain Food Claims Relating to the Development and Health of Children
On March 9, 2015, the European Commission issued Commission Regulation (EU) 2015/391 of March 9, 2015, refusing to authorize certain health claims made on foods and referring to children's development and health. The rejected claims relate to complex carbohydrates, choline, and beta-palmitate.
EFSA Launches Scientific "Data Warehouse"
The European Food Safety Authority ("EFSA") has published the access rules of its data warehouse project, which aims to make available, over the coming years, as much as possible of the data collected by EFSA, in its EU Member States network, and submitted by other data providers. Gradually, over the course of 2015, different stakeholders (for example, data providers, EFSA scientific staff and experts, risk managers, the general public) will be granted access.
Registration Open for EFSA's Dietetic Products, Nutrition and Allergies Meeting
Registration is open until April 1, 2015, for observers to attend the April 23–24, 2015, plenary meeting of EFSA's scientific Panel on Dietetic Products, Nutrition and Allergies in Leuven, Belgium.
EFSA Sets Daily Population Reference Intakes for Vitamin A and Consults on Vitamins E, B12, and Phosphorous
EFSA's Panel on Dietetic Products, Nutrition and Allergies has set daily population reference intakes ("PRIs") for vitamin A of: 750 μg for men and 650 μg for women, 250 to 750 μg for infants and children, and 700 μg for pregnant women, which is higher than the adult PRI to allow for needs of the fetus and the growth of maternal tissues. EFSA is now consulting on PRIs for vitamin E, vitamin B12, and phosphorus.
European Parliament Signs New Law on Genetically Modified Crop Cultivation
On March 11, 2015, the European Parliament signed off on a new law that will break the deadlock and allow new GM crop varieties to be grown in Europe. The law, which was a compromise, allows Member States to ban GM cultivation even if approved by the European Commission. The law was published in the Official Journal on March 13, 2015, and will enter into force 20 days after date of publication.
Deadline for Stakeholders' Comments on Performance Check of EU General Food Law Regulation
In December 2013, the European Commission initiated a fitness check of EU food legislation in order to identify burdens, inconsistencies, gaps, and ineffective measures, referred to as the REFIT. The first step in the REFIT is a fitness check of Regulation 178/2002 laying down the general principles and requirements of food law. The REFIT will be based on case studies in four key areas identified within Regulation 178/2002—traceability, responsibilities of business operators in the food chain, risk analysis, and precautionary principles and principles of transparency of EFSA.
In January 2015, the Commission invited stakeholders to complete a questionnaire related to those case studies. The survey will be open until March 27, 2015, and is available here. Stakeholders were also invited to submit general comments on Regulation 178/2002 by the same deadline. Aleš Bartl of Jones Day is a representative of the European Food Law Association ("EFLA") for preparation and submission of EFLA comments within the REFIT.
Upcoming Meetings, Workshops, and Conferences
National Wildlife Services Advisory Committee Meeting, March 17–19, 2015, in Riverdale, MD.
Public Meeting on U.S. Positions for Codex Committees, Residues of Veterinary Drugs in Foods, March 19, 2015, in Washington, D.C.
HHS and FDA Meeting on Scientific Report of the 2015 Dietary Guidelines Advisory Committee, March 24, 2015, in Bethesda, MD.
FDA-JIFSAN Dietetics and Nutrition Spring Webinar Series, March 24 and April 20, 2015, via webcast.
FDA Public Workshop: The 2015 Office of Regulatory Science and Innovation Science Symposium, April 27, 2015, in Silver Spring, MD.
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.
Recent Product Recalls
Recent food recalls involved undeclared ingredients, potential microbial contamination, and plastic contamination, among others.
Undeclared allergens continue to be a major trigger of food recalls, with more than 12 manufacturers recalling FDA-regulated products for this reason alone since we last reported on recalls in February 2015. The undeclared ingredients included egg, peanuts, almonds, milk, yellow #5, pecans, and sulfites. USDA also reported several recalls for this reason (see below).
Since our last report on recalls, microbial contamination accounted for only one recall: raw hazelnuts were recalled for potential Salmonella contamination. In addition, pierogies were recalled for plastic contamination, and a line of sheep formula was recalled for potentially containing a higher-than-acceptable level of copper.
In continuance of a growing trend, more weight loss supplements products were recalled after FDA discovered the products contained undeclared drug ingredients.
USDA also reported several recent recalls involving undeclared allergens in sausage and beef products. Other USDA-regulated product recalls included various beef products for possible Listeria contamination and pork, sausage, and various beef products for misbranding. Beef jerky was recalled due to a processing deviation, and pork products were recalled for lack of import inspection.
Recent Warning Letters
Since we last reported on enforcement actions in February 2015, FDA posted warning letters to seafood processors, dairies, dietary supplement manufacturers, and other food companies for violations related to CGMP (current good manufacturing practice), commodity-specific regulations, labeling, illegal drug residues, and unapproved drug claims, among others.
FDA warned one bottled water manufacturing facility for various CGMP violations, including packaging the water in insanitary conditions and failure to conduct follow-up testing to determine if the water was positive for E. Coli. Three seafood processing facilities, one located in China and one in Japan, were cited for failing to comply with hazard analysis and critical control points regulations and for various CGMP violations, and one facility was additionally warned for processing seafood in insanitary conditions. FDA also warned five dairy farms for selling cattle adulterated with illegal drug residue for slaughter. A cattle auction facility and a swine farm were cited for offering for sale an animal for slaughter that contained unapproved new animal drugs. Two pet food companies received warnings for selling unapproved new animal drugs, after FDA reviewed the products' websites and Facebook pages and determined the company was marketing the products as drugs.
FDA continues to review product labels for incorrect or incomplete claims. FDA cited a Japanese manufacturer of eel grilling sauce products and a Latvian manufacturer of wafer cakes and biscuits for labeling violations, including failure to use the common or usual name of each ingredient and failure to follow the correct format for the nutrition facts labels.
FDA continues to ramp up enforcement of dietary supplement manufacturers, with a particular recent focus on weight loss and erectile dysfunction products that contain unapproved drugs. Since our last report of enforcement actions, FDA posted 14 warning letters to dietary supplement manufacturers. All 14 supplement manufacturers were warned for marketing unapproved drugs because the products are promoted for therapeutic claims. Two supplement manufacturers were additionally cited for CGMP violations, and three were also warned for insufficient labels, such as failure to include a domestic address or phone number on the label, incorrect serving sizes, failure to identify the part of the plant from which ingredients are derived, incorrect or false nutrient content claims, and failure to correctly declare the level of ingredients in the products.
View FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).
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