GMA Announces Initiative to Address Criticisms of GRAS Exemption

By Mark L. Itzkoff

We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Interest.  In response to these criticisms, the Grocery Manufacturers Association (GMA) recently announced a 5-part initiative to improve the procedures used by the food industry to determine if a food ingredient is generally recognized as safe (GRAS) and to assure the public that ingredients used in processed foods are safe.  While the GMA initiative is focused on self determinations, rather than GRAS Notifications, it will likely have a significant impact on all companies producing or using GRAS ingredients.

The initiative is comprised of 5 separate projects:  (1) a Publicly Available Standard (PAS) that will establish guidelines for conducting a GRAS assessment; (2) a GMA-sponsored database that will contain information on GRAS substances; (3) a Code of Practice (COP) that requires that any GRAS ingredient purchased by a GMA member has been evaluated in accordance with the PAS; (4) expansion of GMA’s current educational programs, including GMA support of the Center for Research and Ingredient Safety at Michigan State University; and (5) an expanded communications plan to inform the public “of the steps being taken by industry to increase the integrity of procedures used to assess ingredient safety.”

During a recent presentation describing the initiative, GMA representatives stated that the PAS will be developed by an independent standard setting agency, such as the American National Standards Institute (ANSI), and that GMA has issued a Request for Proposal (RFP) for this project to three groups.  GMA estimates that the standard will take about two years to develop.  GMA also stated that while details of the PAS will be determined independently, the standard will require 3rd party certification of all companies, toxicologists or consultants conducting GRAS determinations.  To receive certification, the company or consultant will need to establish a standard operating procedure (SOP) for GRAS evaluations and have the procedure approved before performing a certified review. The standard would only apply to “self determinations” that are based on scientific procedures, i.e., would not apply to determinations based on common use in food prior to January 1, 1958.  While the PAS would not apply to determinations submitted to FDA as part of GRAS Notifications, it is likely that it will indirectly become a requirement for these determinations, as well.  GMA also stated that ingredients currently used in compliance with a self-determination would be exempt from the PAS for the current applications, but new uses would not be exempt.  Substances that are the subject of GRAS review by the Flavorings and Extracts Manufacturers Association (FEMA) would also be exempt from the PAS.

All companies preparing GRAS determinations in compliance with the PAS will be required to submit the supporting information, including a list of the safety studies reviewed and the exposure data used, to the GMA-sponsored database.  The database will reportedly include three classes of information, including information that will be made available to the public, information that will be submitted to FDA, and information that will be available to GMA members.  GMA is asking for input on how to delineate the three categories.  It is not clear whether other trade associations will be permitted to participate in the database and gain access to the information for their members.

GMA’s Board of Directors has approved a new COP regarding the use of GRAS ingredients and reportedly all GMA members have agreed to abide by the COP.  GMA has not yet released the COP, but has said that it requires all members to purchase only GRAS ingredients that have been certified for compliance with the PAS.  The COP will become effective January 5, 2015.  GMA did not discuss how the COP will address the use of ingredients deemed to be GRAS after the COP goes into effect, but before the PAS is adopted.

While compliance with the GMA PAS will not be required under the Federal Food, Drug and Cosmetic Act or FDA regulations, its impact may be similar to a new FDA regulation.  GMA membership includes many of the largest food processing companies in the United States, including The Hershey Company, The Campbell Soup Company, and McCormick and Company.  It is our understanding that once the GMA-sponsored PAS is adopted, any company opting not to have its GRAS determinations conducted by certified specialists will be precluded from a large percentage of the possible market.  Thus, as a practical matter, suppliers will need to comply with the PAS.

FDA Updates 4 Proposed Rules Implementing FSMA

By Michael J. O’Flaherty

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA).  The proposed revisions address:

  1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (for a summary, click here);
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (for a summary, click here);
  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (for a summary, click here); and
  4. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (for a summary, click here).

The proposed revisions derive from feedback received by FDA from the public during meetings and in tens of thousands of comments submitted on the proposed rules.

The proposed revisions will be published in the Federal Register on September 29, 2014.  FDA will accept comments on the proposed revisions of the four proposed rules for 75 days, while continuing to review comments already received on the portions of the proposed rules that are staying the same.  It has stated that it will not consider comments outside of the scope of the revisions to the original proposed rules.  The agency will consider both sets of comments before issuing final rules in 2015.

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series:

REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA

OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing medical products and foods into the U.S and Canada.  The webinars will include the following topics:

  1. How to Legally Import and Market Medical Devices in the U.S. and Canada

October 1, 2013, 1:00 p.m. EST

  1. How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

October 15, 2014, 1:00 p.m. EST

  1. How to Legally Import and Market Foods and Beverages in the U.S. and Canada

October 29, 2014, 1:00 p.m. EST

  1. Medical Devices, Pharmaceuticals and Food Products as Consumer Products — Additional U.S. and Canadian Regulatory Considerations

November 12, 2014, 1:00 p.m. EST

Each webinar will be approximately 40 minutes long with a Q and A session at the end.  There is no cost to attend the webinars, but space is limited.

To register for one or more of the webinars, please visit http://www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here

Webinar presenters are attorneys of OFW Law and Davis, LLP.

ofw logoWith over 400 years of combined legal experience and more than 30 attorneys and Senior Policy Advisors, OFW Law uses its background in government, medicine, and industry to create innovative solutions for clients in the food, pharmaceutical, medical device, and agricultural industries. OFW Law represents clients from around the world in FDA, USDA, and health care matters before federal agencies, courts, and the U.S. Congress.

Davis LLP logoDavis, LLP is a full service law firm that provides advice and efficient service in over 50 practice areas, including Life Sciences, Food & Beverage, Regulatory & Administrative Law, and Health Law.  Davis LLP works with clients to get products from idea to market, providing strategic advice on approval and marketing, and managing global product portfolios.

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 15, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

  • Requirements for drug importation into the U.S. and Canada
  • Pharmaceutical market approval pathways in both countries
  • Pharmaceutical manufacturing controls in both countries
  • Pricing of brand and generic pharmaceuticals in Canada
  • Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
  • Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
  • Inspections and enforcement

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act.  She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA).  Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market.  She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions.  She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

Big Data and Your Privacy

By John G. Dillard

Note: John authors a regular column in Farm Journal magazine, the most widely-circulated farm publication in the United States.

Agriculture is officially entering the era of big data. Prescriptive planting relies on historical weather trends and satellite mapping coupled with soil sampling, yield monitoring and soon whatever a drone can glean from flying over a field. Using these tools, data flows from a farmer’s equipment to a central database, along with terabytes of information from farms all across the country. While this data transfer is necessary to feed the algorithms that will compute an individual farmer’s planting prescription, it also has value that extends well beyond its use for prescriptive planting.

One of the primary concerns many producers have about prescriptive planting programs is the ownership of the data. Most farmers view the information about their farm as personal. Although you might brag or complain about yields in the truck line at the grain elevator, you do not necessarily feel comfortable with a computer jockey who is five states away sharing your yield data. If this data can be sold, many farmers want to know how it will be used.

Click here to read the rest of John’s Farm Journal column.

2014 Global Child Nutrition Forum, Sept. 29-Oct. 3

By Peter B. Matz

The 2014 Global Child Nutrition Forum is fast approaching and, while space is limited, there is still opportunity to attend, exhibit and/or sponsor the Forum.  This year’s event is being held by the Global Child Nutrition Foundation and World Food Program outside Johannesburg, South Africa, from September 29-October 3.

This conference is held annually to support countries in the development and implementation of sustainable school feeding programs, i.e. programs that can be maintained long-term with a connection to local agriculture.  This year’s theme is “Nutrition and School Feeding: Improving Nutrition by Strengthening School Feeding Programs,” with a focus on the multi-sector benefits of sustainable school feeding programs and the United Nations Post-2015 Agenda.

Who’s invited?  Representatives of government offices, companies, international organizations, NGOs, academic institutions, and others interested in school feeding and child nutrition programs, as well as the link between agriculture and school feeding programs in Africa.

In particular, participation is encouraged among the sectors which gain the most benefit from investing in nutritious school meal programs with a connection to local farm production: Education, Agriculture, Finance, Health, Industry and Trade, and Budget and Planning.

Why attend?  The Forum is an opportunity to share your experience, successes, and challenges in school feeding and to learn what others are doing, as well as to interact with experts from around the world, see school feeding in action in South Africa and exhibit your programs and products in the Market Place.  Further, the Forum provides the ideal opportunity to contribute to the discussions on the UN Post-2015 Agenda on the development of partnerships among smallholder farmers, governments, the private sector and stakeholders in adding value across the supply chain through school feeding programs.

For further information about the event and/or to register, please visit www.gcnf2014.orgPlease note that registration is being handled exclusively through this website.

How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 1, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics will include, among others:

  • Device classification schemes in the U.S. and Canada
  • Marketing authorization mechanisms in Canada and the U.S.
  • Manufacturing controls in both countries
  • Canadian and U.S. labeling and promotional requirements and restrictions
  • Reporting of adverse events in both countries
  • Recordkeeping and reporting requirements imposed by both countries

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Neil O’Flaherty is a principal at OFW Law, a Washington, D.C.-based law firm, where he has been practicing as a member of the firm’s Medical Device Practice Group for more than 23 years. Neil advises clients from around the world on a wide range of matters relating to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices. Of particular relevance, Neil assists clients with labeling and promotional issues, the development of strategies to bring medical devices to market, pre-submission advocacy, adverse event reporting compliance and other postmarket requirements, and preparation of necessary regulatory filings.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by Canada’s Food and Drugs Act, its related regulations, and their intersection with intellectual property issues. She advocates before all branches of Health Canada on behalf of the medical device, pharmaceutical, biotech, food and beverage, natural health product, and cosmetic industries. Sara works with clients to get products from idea to market while providing advice on approval and marketing strategies.

White House U.S.-Africa Leaders Summit: Agriculture Prospective

By Marshall L. Matz and Eden Shiferaw

“…agriculture development is critical, because it’s the best way to boost incomes for the majority of the Africans who are farmers, especially as they deal with the impacts of climate change…”  President Obama, August 5, 2014

What is the White House U.S.-Africa Leaders Summit?

The first ever U.S.-Africa Leaders Summit took place on Monday, August 4th through Wednesday, August 6th. The Summit involved the United States, over 50 African heads of state, and the African Union. The Summit was organized around the theme “Investing in the Next Generation.” Summit participants discussed investment issues, peace and security, governance, and other topics. The Summit and associated events highlighted key goals in the White House Administration’s 2012 Africa Strategy, which focuses on U.S. efforts to help African countries to foster:

  • good governance;
  • food security;
  • increased economic growth, trade, and investment, in partnership with U.S. firms;
  • durable peace and security; and
  • greater socio-economic opportunity and development.

Initiatives and Partnerships Related to Agriculture

  • Global Resilience Partnership, a $100 million partnership launched by United States Agency for International Development (USAID) and The Rockefeller Foundation was announced at the Summit. The Global Resilience Partnership will institute a new model for solving the complex and interrelated challenges of the 21st century such as persistent and often extreme poverty, food insecurity, and climate shocks through public-private partnerships.
  • Through the Feed the Future initiative, the U.S. Government stands alongside its partners in Africa to promote agricultural development as a means to catalyze broad-based economic growth that can make a significant impact against hunger, poverty and undernutrition. The U.S. reiterated its commitment to enable smallholder farmers and producers with access to agricultural insurance so that they can feel comfortable adopting and using new tools, technologies and practices that can help increase yields and, ultimately, economic outcomes.
  • The New Alliance for Food Security and Nutrition report was released at the Summit, announcing that, under the effort, private sector companies have collectively committed more than $8 billion in responsible agriculture investments in Africa, African governments have made progress or completed 95 percent of their policy-related commitments, and 3 million smallholder farmers have been reached.
  • The Global Open Data for Agriculture and Nutrition (GODAN) initiative will now have four new partners and up to $1 billion in export credit guarantees that will enhance trade between the U.S. and Africa.
  • The United States intends to join the global Alliance for Climate Smart Agriculture (ACSA) slated for launch at the United Nations Secretary General’s Climate Summit in New York in September 2014. At the Summit, the African Union Commission shared its plans for a roadmap to implement the Malabo Declaration’s commitments, including actions to build resilience to climate and weather-related risks through Climate-Smart Agriculture (CSA).

Administration’s Comments on Agriculture

  • Secretary of State John Kerry: “When you talk about food security, it doesn’t take very long to have the name, Norman Borlaug, come up. Norman would have been 100 years old this year, and he dedicated his entire life and career to feeding the world’s hungry. He won a Nobel Prize for his work. And he pursued that path for one reason. As he put it, ‘You can’t build a peaceful world on empty stomachs and human misery,’ pretty simple.

But on top of that, the growing impacts of climate change are going to put extraordinary stress on our ability to be able to produce the amount of food that we need to be able to feed those increasing numbers, and, I might add, to feed from increasing numbers from increasingly – from agricultural locations that are increasingly under greater stress and duress…

We need more governments, more businesses, more research institutions, more civil society, more people all over the world focused on improving agricultural productivity, on investing in innovation and technology like seeds that withstand drought and floods, and on ensuring the world’s agricultural sector is operating as sustainably as possible…”

  • Secretary of Agriculture (USDA), Tom Vilsack: As a panelist during the “Resilience and Food Security in a Changing Climate” event, Secretary Tom Vilsack discussed the three goals USDA is focused on, including advancing sustainable agricultural practices, building greater resiliency in agriculture, and reducing greenhouse gas emissions related to agriculture. Secretary Vilsack said USDA can share research data on crop genomes, pest and disease control, as well as monitoring and addressing drought conditions.

Overview

The Administration considers global food security a top foreign policy priority. It is not just Africans and African leaders recognizing the importance of agriculture, the Summit demonstrated the Administration’s understanding that agriculture is the key to Africa’s economic prosperity. Furthermore, the Administration accepts that a “green revolution” in Africa cannot take place without Climate-Smart Agriculture (CSA) technology. The Administration repeatedly alluded to biotechnology by advocating for smart, sound science in order to combat the effects of climate change.

The Administration purposely refrained from offering a set of deliverables from the Summit, however, it should be noted that the Administration is enthusiastic about Africa Growth Opportunity Act (AGOA) and Feed the Future. Throughout the Summit, the Administration reiterated that AGOA and Feed the Future are top legislative priorities.

Despite the Administration refraining from deliverables, the Summit was a successful bipartisan effort. “Congress has played an enormous role on a bipartisan basis in supporting Africa policy,” said Ben Rhodes, the deputy national security adviser for strategic communications. “It is important to note that in an environment in Washington where there’s not a lot of bipartisan agreement, Africa has been the true exception.”

Links

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada 1

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series:

REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA

OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing medical products and foods into the U.S and Canada.  The webinars will include the following topics:

  1. How to Legally Import and Market Medical Devices in the U.S. and Canada

October 1, 2013, 1:00 p.m. EST

  1. How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

October 15, 2014, 1:00 p.m. EST

  1. How to Legally Import and Market Foods and Beverages in the U.S. and Canada

October 29, 2014, 1:00 p.m. EST

  1. Medical Devices, Pharmaceuticals and Food Products as Consumer Products — Additional U.S. and Canadian Regulatory Considerations

November 12, 2014, 1:00 p.m. EST

Each webinar will be approximately 40 minutes long with a Q and A session at the end.  There is no cost to attend the webinars, but space is limited.

To register for one or more of the webinars, please visit http://www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here

Webinar presenters are attorneys of OFW Law and Davis, LLP.

ofw logoWith over 400 years of combined legal experience and more than 30 attorneys and Senior Policy Advisors, OFW Law uses its background in government, medicine, and industry to create innovative solutions for clients in the food, pharmaceutical, medical device, and agricultural industries. OFW Law represents clients from around the world in FDA, USDA, and health care matters before federal agencies, courts, and the U.S. Congress.

Davis LLP logoDavis, LLP is a full service law firm that provides advice and efficient service in over 50 practice areas, including Life Sciences, Food & Beverage, Regulatory & Administrative Law, and Health Law.  Davis LLP works with clients to get products from idea to market, providing strategic advice on approval and marketing, and managing global product portfolios.

How Would an FDA Standard of Identity for Honey Benefit Consumers, the Honey Industry, and U.S. Agriculture? USDA Wants to Know.

By Robert A. Hahn

The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) has published a Federal Register notice requesting comments on a possible federal standard of identity for honey.

Although the Food and Drug Administration (FDA) is the agency that would be responsible for developing a standard of identity for honey, the 2014 Farm Bill charged the Secretary of Agriculture with developing a report describing how a standard of identity would be in the interest of consumers, the honey industry, and U.S. agriculture.  Section 10012 of the Agricultural Act of 2014 specifically requires USDA to consider a March 2006 citizens petition to establish a standard of identity for honey submitted by the American Beekeepers Federation and several other honey-related trade associations.  The 2006 petition asked FDA to establish a standard of identity similar to the Codex Standard for Honey (CODEX STAN 12-1981, Rev. 2 (2001)).  FDA denied the petition in 2011, claiming that it did not demonstrate the need for an FDA standard of identity for honey and that existing law is sufficient to protect the integrity of honey.  The petition and FDA’s denial can be found here and here.

FDA recently issued a draft guidance document on proper labeling of honey and honey products, Draft Guidance for Industry: Proper Labeling of Honey and Honey Products (see our post dated April 8, 2014).  According to the draft guidance, “honey” is the common or usual name for “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.”  Only products made exclusively from honey may be called “honey.”  In the absence of a federal standard of identity, a number of states have adopted, or proposed to adopt, their own state standards of identity for honey, creating the potential for a patchwork of differing state standards of identity that could impede interstate commerce.   In addition, USDA/AMS has voluntary grading standards for honey: U.S. Standards for Grades of Comb Honey and U.S. Standards for Grades of Extracted Honey.

USDA/AMS is requesting comments on the 2006 petition to establish a standard of identity for “honey,” and specifically on the adoption of certain deviations from the Codex standard proposed by the petitioner.  Comments are due September 19, 2014.

Even if the Secretary of Agriculture’s report supports creation of an FDA standard of identity for honey, that recommendation would not be binding on FDA.  However, FDA might be persuaded to reconsider its conclusion that a federal standard of identity is unnecessary if there are conflicting state standards.  If FDA does adopt a federal standard of identity for “honey,” it would preempt any state standards that are not identical to the federal standard.