Why Biotech Food Labeling Is Met with Resistance

In recent weeks, there’s been a lot of new discussion around the biotech labeling debate.  On May 10, the International Food Information Council (IFIC) released its latest “Consumer Perceptions of Food Technology” survey, which showed that very few Americans cite biotechnology as an information need on food labels.

Earlier this month, the California Right to Know initiative announced at various rallies held around the state that it had collected the prerequisite number of signatures to get its proposal on the November ballot. The initiative would require biotech foods (also known as Genetically Modified Organisms, or GMOs) and foods containing GMO ingredients to be labeled.

A number of mainstream media outlets reported on the California activity. Andrea Billups’ piece in the Washington Times and Jack Kaskey’s article for Bloomberg nicely sum up why the broader agriculture and food manufacturing community is opposed to the measure:

The California campaign is the best chance for biotech labeling in the United States after the failure of similar bills in 19 states and the rejection of a petition to the Food and Drug Administration last month.

But the California voter initiative is likely to meet fierce resistance from agricultural and business interests, who predict it will prove costly both for growers and consumers. Opponents warn the measure constitutes a “right to sue” initiative that will undercut sales of numerous food items that have been consumed safely for years.

Monsanto opposes labeling modified ingredients because the move risks “misleading consumers into thinking products are not safe when in fact they are,” said Sara Miller, a Monsanto spokeswoman.

The initiative is a “back door” way to hurt the $13.3 billion biotech crop industry, according to Richard Lobb, managing director for the Council for Biotechnology Information. The Washington-based council represents Monsanto and five other biotech-seed developers. “They basically are trying to scare consumers through labeling,” Lobb said in a telephone interview. “The obvious objective is to push biotechnology out of the market altogether.”

Biotech labeling has never been endorsed by the FDA. The agency says crops engineered to tolerate herbicides or produce insecticide pose no greater health risks than conventional foods.

The California Farm Bureau opposes the ballot initiative, along with the California Chamber of Commerce, the California Seed Association, the California Grain and Feed Association, and California Women for Agriculture.

Jamie Johansson, vice president of the California Farm Bureau and an olive farmer from Oroville, Calif., said the initiative puts an enormous burden on growers and packagers, and it prevents any processed food from being labeled as “natural.”

An apple, for example, wouldn’t require a label, but it would if it were ground into apple sauce. The same for almonds: They are fine picked raw, but ground into almond butter, even without any other ingredients, they would not pass the test under provisions of the proposed label law.

Food labels should be reserved for “critically important food safety and nutritional information,” said Brian Kennedy, a spokesman for the Grocery Manufacturers Association, which opposes the California initiative.

The California proposal would mandate a label for foods in which more than 0.5 percent of the product is a genetically modified ingredient. The proposal exempts meat, dairy foods and beer.

The label “would be the equivalent of a skull and crossbones” that would drive away customers and force food producers to stop using engineered ingredients, Joseph Mercola, the labeling initiative’s leading funder with $800,000 in donations, said. Mercola is an osteopath who promotes natural remedies at his clinic in Hoffman Estates, Illinois.

Martina Newell-McGloughlin, director of the University of California Systemwide Biotechnology Research and Education Program, called the labeling proposal “completely blown out of context.”

“To me, the issue with this as a scientist is you are focusing on the labeling of process rather than the labeling of product,” she said. “The issue for safety should be on the product itself if you are going to look at risk-assessment and whether something should be of concern to the consumer.”

“You don’t have a label on sausage telling you how they are made and you probably wouldn’t want one. For biotech products, the issues are an individual’s right to know. If you were going to ask to supply all information made on a processed crop, you’d have a whole encyclopedia attached to everything on your grocery shelf.”

Chris Shaw, a New York-based analyst, said labels identifying genetically modified organisms, or GMOs, won’t change most consumers’ buying decisions. “People who are buying Oreos aren’t going to care if there is GMO soybean oil in there,” Shaw said. “It’s going to be a marginal group of people that will care.”

That’s the consensus of consumers who participated in the IFIC survey.  Seventy-six percent of respondents could not think of any additional information (other than what is already required) that they wish to see on food labels.  Of the 24 percent who wanted more information, only 3 percent (or about five people and less than 1 percent of all surveyed) wanted more information about biotechnology. In addition, 87 percent of Americans say they have not taken any action out of concern about biotechnology.

IFIC President and CEO David Schmidt said the strength of the methodology used in the IFIC survey sets it apart from other surveys looking at food technology issues.

“In the public landscape, we often see polling that tries to provoke or frighten people into giving a certain desired response,” Schmidt said.  “We don’t believe in leading consumers to any conclusion.  We believe our open-ended methodology used at the beginning of our survey provides a more accurate view of concerns on Americans’ minds, and the survey is the most objective and long-term publicly available data set on U.S. consumer attitudes toward food and agricultural biotechnology.”

The survey, formerly the “IFIC Survey of Consumer Attitudinal Trends toward Food Biotechnology,” is part of a series that has been conducted since 1997.

Congressional Hearing on International Patent Issues: BIO Submits Comments

The House Judiciary Committee conducted a hearing on World IP Day on “International Patent Issues: Promoting a Level Playing Field for American Industry Abroad.”  BIO submitted written comments for the record highlighting the unique patenting challenges that biotechnology companies face around the world.

“To fully understand what is needed to level the playing field for the biotechnology sector in international markets, one must understand the intellectual property (IP) needs of the biotechnology sector.  Biotechnology innovation requires predictable and effective upstream (early stage) and downstream (product) IP protection.  Biotechnology innovation generally starts with an early laboratory discovery, and thus upstream protection helps to generate investment and interest in the further, applied research and development of the invention.  Upstream protection includes broad patent eligibility for biotech innovations, consistent patent term, flexible licensing practices, and effective patent enforcement.

Downstream protection is just as important.  As mentioned above, the research and development of a biological product can take decades and cost more than a billion dollars to complete.  A significant portion of this time and money goes towards developing the regulatory data package that is required by the U.S. FDA, USDA, or similar foreign regulatory offices to approve the biotech product.   Therefore, downstream protection for biotech products must include sufficient protection against foreign and domestic competitors relying on the innovator’s data package to secure abbreviated approval of competitive products in such markets. “

Read the Full Comments

The JOBS Act: A Boost for Biopharma?

By Christopher Allen, Associate Editor, Pharmaceutical Technology.

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart.

According to recent data from the US Bureau of Labor Statistics, the national unemployment rate has been above 8% for more than three straight years (with some estimates above 17% for underemployment, which includes potential workers who are not even and/or no longer counted by labor statistics). A central issue for the 2012 Presidential campaign will rest on candidates’ strategies for dealing with how to stimulate economic growth in order to restore prosperity to levels not realized in this country for seemingly an eternity.

The Jumpstart Our Business Startups (JOBS) Act (H.R. 3606), which aims to ease regulatory barriers for start-up businesses, recently passed in the US House of Representatives by a 380-to-41 vote on Mar. 8, 2012, and the Senate on Mar. 27. According to H.R. 3606’s official summary (obtained from GovTrack.us), the bill “Modifies the application to emerging growth companies of any auditing or other professional standards the Public Company Accounting Oversight Board may establish that were proposed by one or more professional groups of accountants. [The bill also] exempts an emerging growth company from any such rules requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the issuer’s financial statements (auditor discussion and analysis).”

The measure has been hailed by several biopharmaceutical manufacturers as well as the Biotechnology Industry Organization (BIO). In a Mar. 27, 2012 press release, BIO President and CEO Jim Greenwood said, “BIO applauds passage of the JOBS Act and all efforts to incentivize and encourage capital formation for growing companies working to develop breakthrough medicines and cures for devastating diseases. These reforms are especially important to innovative biotechnology companies that must spend investor dollars to address bureaucratic red tape and hurdles rather than the search for cures and breakthrough medicines.”

Additionally, according to the BIO release, the JOBS Act “creates an ‘on-ramp’ to the public market for emerging growth companies, allowing them five years to focus on conducting critical research that can lead to cures for debilitating diseases—such as cancer, HIV/AIDs and Parkinson’s disease—before having to divert funds to address bureaucratic hurdles that cause unnecessary delays. Through this legislation, emerging growth companies will be exempt for their first five years on the public market from the compliance burdens of Sarbanes-Oxley Section 404(b), which the Securities and Exchange Commission (SEC) studies estimate cost companies up to $2 million per year.”

The JOBS Act also aims to:

• Expand the eligibility requirements of SEC Regulation A to include companies conducting direct public offerings of up to $50 million

• Increase the limit that requires private companies to register with the SEC from 500 to 2,000 shareholders

• Require the SEC to revise Rule 506 of Regulation D to permit general solicitation in direct public offerings, broadening the investor base.

In highly regulated industries such as the biotechnology and pharmaceutical manufacturing sectors, any measure to appropriately toss aside bureaucracy in order to foster growth and research certainly opens up doors for potential major breakthroughs. Such breakthroughs can yield the promise for massive dividends, both financially and in terms of saving lives.

Bringing Hope to Patients

No-one expected Hope Bartley to survive after she was born three months early. Thanks to extraordinary biotech medicine, she did. Alena Galan, age 14, is one of only a few thousand patients with a rare disease called MPS. Thanks to the hard work of leading biotech scientists and the approval of a new treatment, she now has a chance to lead a normal life. Lori Lober experienced the unthinkable when she was diagnosed with Stage IV metastatic breast cancer. Now, 11 years after her diagnosis and treatment, Lori is full of life…and hope.

These are just a few stories that represent the challenges millions of patients living with debilitating diseases face every day. These are exceptional cases, highlighting extraordinary individuals, that are told in an exciting new documentary, “From Despair to Hope: A New World of Treatments” airing tonight — Wednesday, March 28th — on WUSA-TV (CBS), Channel 9, here in Washington, D.C., at 9:00 p.m. EST.

“From Despair to Hope” introduces a diverse group of amazing patients and their families who are living with a variety of the most devastating diseases facing humankind, including cancer, multiple sclerosis, HIV/AIDS, sickle cell disease and several rare diseases. Through their individual stories of courage, hope and survival, these patients tell us how breakthrough biotechnology medicines and therapies have saved and improved their quality of life.

We know that patients and their families are often biotechnology’s best advocates. They personalize the complex science and the mind-boggling numbers related to biotechnology and health care: The overwhelming number of patients living with debilitating diseases, the escalating costs, and the billions of dollars required to bring new therapies and treatments from the research bench to bedside.

Even as we celebrate these amazing stories of survival, we also know that there are millions of patients awaiting the next biotech breakthrough that may provide them with renewed hope. We know that biotech researchers around the country are working hard to turn that hope into reality. We look forward to working with our member companies, members of Congress, and our allies throughout the world to advocate for a more streamlined and forward-thinking regulatory review process that will ensure that innovative biotech firms can focus their resources where they belong – in research and devleopment that leads to breakthrough medicines and cures, and job creation – rather than navigating an overly complicated and murky regulatory process. And we will continue our efforts to advocate for policies that encourage investment in biotech innovation.

I personally would like to thank you in advance for watching and for your continued support of biotech innovation.