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

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.


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.”


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:


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

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.


By John R. Block

What should we be eating? We are getting hammered from every angle about what is good for us versus what is bad. Too many carbs, stay away from red meat, don’t trust GE foods, sugar will make you fat. The government wants to regulate.

We have been through this before but never with the intensity that we face today. I remember when they said, “Butter is bad for you. Eat margarine.” Now, it is the other way around. At one time, some critics advised to not eat bacon because when you fry it, it is a carcinogen. How can the average consumer know what to do?

The World Health Organization, following the advice of a Tufts University research study, advised that we cut our salt consumption in half. The salt we eat leads to 1.65 million deaths annually. Excessive sodium results in high blood pressure, stroke, and heart disease. Our Food and Drug Administration plans to work with our food companies to get them to cut back the salt. FDA argues that we should consume less than 2,300 milligrams of sodium per day. High levels are associated with high blood pressure. The average U.S. sodium daily consumption is 3,400 milligrams. Simply put – we are consuming too much salt.

However, we have a new study published in the New England Journal of Medicine which tells us that if we cut back on our salt we will have a heart attack. The new study involved 100,000 people in 17 countries over 3 years. They found that individuals that consumed the low level of sodium recommended by the FDA had a 27% higher risk of death.

The new study suggesting that we aren’t consuming too much sodium today contradicts the position of the American Heart Association, the World Health Organization, and FDA.

Perhaps USDA’s Dietary Guidelines Advisory Committee should consider making some adjustment in their recommendations – that is, if “they are worth their salt.”

As for me, I’ll still salt my steak and eggs and, to be safe, I’ll have another piece of bacon and a glass of red wine.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

Lupin, A Legume Becoming More Popular In The US, May Cause Allergic Reactions

By Robert A. Hahn

FDA has issued a Consumer Update (Allergies to a Legume Called Lupin: What You Need to Know) and FAQs (Frequently Asked Questions on Lupin and Allergenicity) on lupin, a legume belonging to the same plant family as peanuts.  According to the agency, lupin can cause severe allergic reactions, including life-threatening anaphylaxis, in allergic individuals.  While some individuals develop an allergy to lupin over time, others may have an allergic reaction on their very first exposure.  Persons with peanut allergies are at greater risk of being allergic to lupin.

Because lupin is relatively new in the U.S. food supply, many Americans are not familiar with it.  It is becoming more popular, however, because of its use in gluten-free foods.  Lupin and ingredients derived from lupin, such as lupin flour and lupin protein, are good substitutes for gluten-containing flours in baked goods and pasta.  Lupin is also found as a whole bean (called “lupini beans”) sold in Italian and other ethnic specialty stores.  Lupin or lupini beans are a traditional food in Mediterranean and some Asian cuisines.

Lupin and ingredients derived from lupin are required to be listed in the ingredients declaration on food labels.  FDA advises consumers, particularly those with peanut allergies, to look for “lupin” or “lupine” on the label.

While lupin is not a “major food allergen,” it seems possible that FDA might consider undeclared lupin to be a food safety hazard that could trigger the need for a recall.  The term “major food allergen” is defined as the “Big 8” (i.e., peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish) and any ingredient that contains protein derived from the Big 8, except for: (a) highly refined oils and ingredients derived from highly refined oils, and (b) ingredients that FDA has exempted from the definition of “major food allergen” under Federal Food, Drug, and Cosmetic Act § 403(w)(7) (21 U.S.C. § 343(w)(7)).  Although not a major food allergen, lupin might fall into the category of foods (which includes sulfites, Yellow No. 5 and 6, and MSG) that, although not major food allergens, will typically trigger a recall if present in a food but not declared on the label.

FDA is “actively monitoring” complaints of allergic reactions to lupin.

FDA’s “Gluten-Free” Labeling Rule Takes Effect

By Robert A. Hahn

On August 5th, FDA’s regulation defining the claim “gluten-free” for voluntary use in food labeling became effective.  FDA cautions consumers that there may still be some products on store shelves labeled “gluten-free” that do not comply with the new definition, but all foods entering commerce on or after August 5, 2014 must comply.

Here are the key features of the FDA rule:


  • “Gluten” refers to certain proteins (e.g., prolamins and glutelines) in gluten-containing grains that cause adverse health effects in persons with celiac disease.
  • “Gluten-containing grains” are wheat, rye, and barley, as well as hybrids of those grains (e.g., triticale).
  • “Gluten-free” means either: (1) the food and its ingredients are inherently free of gluten, and any gluten present in the food is <20 parts per million (ppm); or (2) the food contains an ingredient derived from a gluten-containing grain that was processed to remove gluten (e.g., wheat starch), and any gluten present in the food is <20 ppm. The bottom line is that the food must contain <20 ppm gluten.


  • FDA prefers the term “gluten-free” and discourages use of other terms, but will accept use of certain equivalent terms (e.g., “no gluten,” “without gluten”). Other truthful and non-misleading statements about gluten content are also permitted including: a statement of the amount (or maximum amount) of gluten in the food; a statement such as “not made with gluten-containing ingredients”; and/or a gluten-free certifying organizations seal or logo.
  • If a food label includes both a “gluten-free” claim and the word “wheat” (e.g., it lists a wheat ingredient that has been processed to remove gluten in its ingredients list), the word “wheat” must be followed by an asterisk that refers to the following statement in close proximity: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”
  • If a food is labeled “gluten-free,” FDA encourages manufacturers to identify any oat-derived ingredients in the food that do not use the word “oats” in their name (e.g., “beta glucan (from oats)”).
  • FDA notes that oats and other (non-gluten-containing) grains, legumes, and seeds may come into contact with “gluten-containing grains” during harvesting, storage, transportation, and manufacturing. Therefore, manufacturers of “gluten-free” foods containing other grains, legumes, or seeds need to be careful such foods contain <20 ppm gluten.


  • Use of the claim “gluten-free” is strictly voluntary.
  • The regulation applies only to packaged foods, including packaged foods sold in restaurants and other foodservice establishments. FDA encourages restaurants to comply with the definition of “gluten-free” for non-packaged foods as well.
  • The regulation applies to FDA-regulated human foods, including dietary supplements. It does not apply to food for animals.  It also does not apply to meat and poultry products regulated by the U.S. Department of Agriculture (USDA) or alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), but FDA is seeking to harmonize with those agencies.

Compliance and Enforcement

  • Manufacturers making “gluten-free” claims are not required to test their ingredients or finished products for gluten. However, manufacturers are responsible for ensuring that “gluten-free” foods comply with the FDA definition.  Therefore, FDA encourages use of effective measures, such as:
    • Testing ingredients or finished foods for gluten;
    • Requiring certificates of analysis from ingredient suppliers; or
    • Participating in a third-party gluten-free certification program
  • If manufacturers of “gluten-free” products do test for gluten, they are not required to use any particular analytical method. However, FDA recommends use of scientifically valid methods, and identifies two ELISA methods that the agency will use in tandem for compliance purposes; they are the R5-Mendez Method (test kit available from R-Biopharm) and the “Morinaga method” (test kit available from Morinaga Institute for Biological Science, Inc.).
  • FDA acknowledges there is currently no scientifically valid method to test for gluten in fermented or hydrolyzed foods. FDA intends to publish a proposed rule explaining how it will evaluate compliance in “gluten-free” fermented and hydrolyzed foods.

FDA has issued a Small Entity Compliance Guide and Q&As on the “gluten-free” rule.

Farming’s transformation starts to change Africa

By Marshall Matz, as published in the Des Moines Register

Next month President Barack Obama is hosting an Africa summit with heads of state and corporate chief executive officers. The timing is excellent.

Africa’s unique green revolution, with its focus on smallholder farmers, is now moving beyond the tipping point. And as smallholder farmers make the transition from subsistence farming to successful entrepreneurs, the continent’s green revolution will fundamentally change the face of Africa.

Last month, the African Union met to mark the 10th anniversary of its comprehensive Africa agriculture development program. The program called on all African governments to invest at least 10 percent of their budgets in agriculture. The new goal is to at least double agriculture production by 2015, sustain annual agriculture GDP growth of at least 6 percent; triple intra-African trade in agricultural commodities and services; create job opportunities for 30 percent of the youth; and end hunger in Africa by 2025.

This bold agenda is doable. Half of those who are hungry in Africa are smallholder farmers. As they move from subsistence farming to entrepreneurs it will change the face of Africa.

While the White House summit will focus on many of the broad issues facing Africa, it will include agriculture and food security. Agriculture is the area where the president has the greatest opportunity to make his mark.

According to Strive Masiyiwa, founder and chairman of Econet Wireless, co-chair of GROW Africa, and chairman of the board of the Alliance for a Green Revolution in Africa, “With broad action on policy, investment and technology, Africa’s farmers can double their productivity within five years.”

The White House African leaders summit is not just important to Africa. It is important to the United States. Six of the fastest-growing economies in the world are in Africa, and Africa is becoming a major market and potential trading partner for U.S. companies.

Further, over half of all the underutilized and unused agricultural land in the world is in Africa. As a result, it is not possible to achieve global food security without Africa. Finally, Africa is an important strategic partner for U.S. national security.

As President Obama said in Tanzania last summer, “In our global economy, our fortunes are linked like never before. So, more growth and opportunity in Africa can mean more growth and opportunity in the United States. And this is not charity; this is self-interest. And that’s why a key element of my engagement with Africa, and a key focus during this trip, has been to promote trade and investment that can create jobs on both side of the Atlantic.”

The attention on African agriculture these past few years is already having a major impact on the ground as it reaches Africa’s smallholder farmers. The immediate focus in Africa is on the 18 African countries that comprise the continent’s two breadbasket regions.

The coordinator and spark plug for translating much of the political attention is the Alliance for a Green Revolution in Africa, working with the African Union, the private sector and other stakeholders. Their bold initiative focuses on seed development, soil health, markets, capacity building, credit and public policy across the African continent.

Plant breeders supported by the Alliance for a Green Revolution in Africa have so far developed over 440 new and improved crop varieties, many of them now starting to increase smallholder productivity. They have helped to establish and strengthen more than 80 private, African-owned and operated seed enterprises. These now produce more than 80,000 metric tons of certified seed of key staple food crops each year — up dramatically from less than 2,500 metric tons in 2006.

More than 1.5 million farmers are now using integrated soil fertility management technologies. Over 2,500 farmer organizations have received intensive business and management training, enabling them to become more sustainable and effective in meeting the needs of smallholder farmers. Some 20,000 agro dealers have been established in rural communities to distribute improved seeds, fertilizer and other inputs. The privately owned agro dealers are also providing extension services to their customers. A more detailed summary of the state of play on the ground in Africa can be found in the Alliance for a Green Revolution in Africa’s 2013 annual report.

At the end of 2013, Kofi Annan, the former secretary general of the United Nations, stepped down as chairman of the Alliance for a Green Revolution in Africa and became its chairman emeritus. In doing so, he said, “We can move forward together knowing that the transformation of African agriculture is now well under way, and has the momentum needed to achieve our shared vision of a uniquely African Green Revolution.”

The secretary general is correct. The African green revolution is well under way. President Obama has the opportunity to greatly increase the pace of that momentum by building on his past leadership and identifying specific goals for future action.

MARSHALL MATZ specializes in agriculture and global food security at OFW Law in Washington, D.C. He serves on the board of directors of the World Food Program USA and the Congressional Hunger Center. He was formerly counsel to the U.S. Senate Agriculture Committee on Agriculture.

John Block: Getting Nothing Done

By John R. Block

Today, I want to talk to you about the deficit – not the dollar deficit. That’s for another day. I want to talk about the deficit of action, the deficit of responsibility.

The U.S. Congress and the President have failed the people. The end of this fiscal year is fast approaching and the Congress (once again) has not completed the appropriation process for next year’s spending. The House Ag Appropriations bill still has not been passed. The Senate Ag bill is stalled and going nowhere.

There is very little time left. The house is scheduled to be in session 4 more days this month – zero days in August – only 10 days in September and 2 days in October.

We’re not going to complete the appropriations process. We’ll do what we have done before. We’ll pass a continuing resolution to keep the government running and funded until after the November mid-term election. Then, the Congress will vote the funding for next year.

Why don’t they get the work done on schedule? The answer is they don’t want to vote on issues now because their vote might hurt their chances of getting reelected. Harry Reid, leading the Senate, is sitting on a basket of bills that the House has approved. He just sits on them. As an example, if he were to allow his Senate Democrats a vote on a bill to stop EPA’s attack on coal-fired plants, it might pass. Coal state Democrats would vote for it. They would have to if they want to get reelected.

President Obama isn’t up for reelection. Why isn’t he in there leading to get things done? He had said at one time he wanted to reform the tax code “riddled with complicated loopholes.” He has done nothing. He wants to negotiate a European trade deal and a Pacific agreement. He doesn’t even have “trade promotion authority.” Any hope we had for immigration reform is lost for now with the thousands of Central American children streaming through our unsecured border.

The list of important issues that need to be dealt with is endless. If you wonder why the Congress is in session for only 16 days over the next three months, it’s because they are on the campaign trail. My advice to you is – go to their events and ask them why they aren’t getting anything done. Tell them, “Quit telling us what you’re going to do. Just do it.”

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

By Michael J. O’Flaherty

Thirty-five (35) years ago, the Washington, DC law firm presently known as Olsson Frank Weeda Terman Matz PC, or simply “OFW Law,” originated as Olsson and Frank, P.C.  It was comprised of two (2) founding attorneys, Philip C. (Phil) Olsson and Richard L. (Rick) Frank, who left another DC law firm to start their own.  Anita Harris (still with the firm as its Director of Finance) moved with them as their legal administrator.

Since its 3-person inception, OFW Law has represented a growing number of conventional food and dietary supplement clients, including manufacturers, distributors, food service establishments, and trade associations.  Over the years, the firm’s Conventional Foods and Dietary Supplements practice groups have grown considerably.  Practitioners at the firm presently engaged in addressing issues in these areas now number 15 and include both attorneys and government relations personnel (i.e., Senior Policy Advisors).

OFW Law’s food/dietary supplements practice team has attained countless successes for our clients in its 35-year history.  Many of these successes were (and must remain) confidential matters.  Nevertheless, some examples of our practice team’s undertakings provide insight into our capabilities:

  • Our professionals were instrumental in the enactment of the Nutrition Labeling and Education Act (NLEA), the FDA Modernization Act (FDAMA), the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act), the Food Allergen Labeling and Consumer Protection Act (FALCPA), the FDA Amendments Act, and the FDA Food Safety Modernization Act.  We also have been actively involved in rulemakings to establish regulations implementing these statutes, as well as in implementation and utilization of the regulations.
  • Our practice team, in a matter that spanned 5 years, assisted a client in securing millions in capital (i.e., dollars and shares) from a “milestone” provision in a merger agreement that opposing counsel had deemed unearned and unattainable.  The matter essentially entailed petitioning FDA for a nutrient content claim; motivating the agency to authorize the claim through discussions with Congressional staff, high level administrative personnel, and attorneys in the Office of Chief Counsel; and (once authorized) collaborating with litigation co-counsel to achieve resolution of the contractual dispute.
  • We partner with our client, The Food Institute, by authoring practical publications for sale, including:
  1. HACCP & U.S. Food Safety Guide (2nd edition);
  2. Food Industry Bioterrorism Act Guide;
  3. Dietary Supplements: A Regulatory Guide;
  4. Guide to Regulation of Food Ingredients and Food Packaging Materials;
  5. Food Labeling Guide (3rd edition);
  6. Importing Food Into The United States;
  7. Guide to Handling FDA Food Inspections (2nd edition); and
  8. Food Products Recall Manual (4th edition).
  • Our professionals have worked with numerous clients to determine the status of their food ingredients under the generally recognized as safe (i.e., “GRAS”) provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 321(s).  We have filed many successful GRAS Notifications for various food ingredients, including: potato and oat hull fibers; cultured dairy, fruit and vegetable materials; cultured corn, cane or beet sugars; and carbon monoxide.
  • Our practice team has represented top food and beverage companies in competitive disputes involving misleading labeling and advertising claims.  Using both traditional and untraditional strategies, our actions on behalf of clients led to cessation of the challenged claims and the restoration of a level competitive playing field.
  • Pursuant to amendment of the FD&C Act to include section 403(h)(3)(B) (21 U.S.C. § 343(h)(3)(B)), we represented a client by preparing and submitting to FDA’s Center for Food Safety and Applied Nutrition a successful notification to authorize in-shell eggs, treated by a proprietary process according to specified minimum processing parameters, to be represented in labeling as “pasteurized.”
  • We have helped several clients obtain temporary marketing permits (TMPs) authorizing the interstate shipment of packs of food varying from the regulatory requirements of FDA’s definitions and standards of identity (e.g., canned fruit cocktail, canned tuna), many of which have not been updated in more than a quarter century.

Like OFW Law generally, our practice team is adept at providing clients with creative solutions to difficult problems.  We look forward to another 35 years of successes.