The GAO, an independent agency that investigates the efficacy of federal programs for Congress, recently issued a report recommending that the FDA reform the way it handles claims made in food labeling. This report comes as a result of a performance audit that the GAO conducted throughout 2010 where the FDAs oversight of qualified health claims and structure/function claims was evaluated.

While health claims are those that characterize the relationship between a food or food component and a health-related condition, “qualified health claims” have an added limitation. In a qualified health claim, the relationship between the consumption of a food and a health-related condition is limited by providing a statement in labeling that qualifies the amount of scientific support backing the claim. In contrast, structure/function claims are those that describe the relationship between a food or food component and its effect on a structure or function of the body.

The key issue that the FDA must consider regarding both of these types of claims is whether food manufacturers possess a level of scientific support to make these claims. The FDA is tasked with overseeing and enforcing federal food labeling requirements, which prohibits the use of false or misleading claims in food labeling. However, in the area of health-related claims, the FDA is not the only agency tasked with enforcing federal requirements. The Federal Trade Commission (FTC) is responsible for enforcing federal laws that prohibit deceptive acts and practices. The FTC shares jurisdiction with the FDA in the area of health-related claims, and where the FDA focuses mainly on food labeling, the FTCs focus is on food advertising.

Although the FDA also targets food manufacturers for making improper claims in advertising, a key distinction between the FDA and FTC is that the latter possesses subpoena power. While the FTC can require companies to turn over relevant evidence concerning the scientific support substantiating its claims, the FDA has no such power. This distinction is highlighted in the GAOs report and according to the GAO, may be a critical factor limiting the efficacy of the FDAs oversight of health-related claims in food labeling. Because of this limited ability to force companies to turn over documents in support of their claims, the GAO concluded its study with a recommendation that the FDA to seek guidance from Congress regarding what authority could be used to require companies to provide scientific evidence of health-related claims.

For more information regarding FDA and FTC regulatory compliance, please contact us at contact@fidjlaw.com.

This week, the FDA announced its plans to overhaul its system for reviewing and clearing medical devices. The plan, which contains 25 distinct actions that the FDA intends to implement in 2011, comes as a result of two internal working groups that were created by the FDAs Center for Devices and Radiological Health (CDRH) in 2009. The CDRH set up these groups in an effort to address widespread concerns regarding the FDAs premarket notification process.

Currently, the most utilized pathway for medical device manufacturers to gain FDA clearance necessary to market new devices is through the 510(k) process. This process requires submitters to provide highly-detailed information regarding the intended use of the device, including any safety issues posed and how the device compares to other devices that have already gained FDA approval or been cleared through this process. In what is known as “substantial equivalence,” the FDA issues a finding allowing new devices to come to market and is primarily based on the perceived link between the applicants submitted comparable devices and the applicant device. Conversely, if the FDA believes that the applicant device is not substantially equivalent to the comparable devices that were submitted, then the Agency will issue a determination of “NSE,” meaning that the device at issue is not substantially equivalent to a legally marketed device. A determination of NSE may be reached for a variety of reasons, including any perceived differences between the intended use of the comparable devices and the applicant device or added risks that bear on the devices safety. Because there have been ongoing concerns regarding the unpredictable and inefficient nature of the 510(k) process, including what truly leads the FDA to conclude a new device is not substantially equivalent, the FDA unveiled its plan to improve this process.

Aimed at increasing the efficiency of the 510(k) process, while ensuring that the safety of new devices on the market is not diminished, the FDA intends to take several actions in the coming year that may greatly impact the pathway for the approval of medical devices. For instance, the Agency plans to publish several draft guidance documents that are intended to create more transparency regarding FDA determinations. To this end, the FDA intends to provide guidance concerning when it believes clinical data should be submitted, what kinds of information supports “intended use,” and how comparable devices should be utilized in 510(k) submissions.

Additionally, the FDA intends to streamline its “de novo” review process, which may help lower-risk medical devices gain the clearance necessary to enter the market. This is particularly important for new devices that cannot point to clear comparable devices on the market but do not pose heightened risks to safety. The de novo process entails a review of a device submission after the Agency has made the initial determination that the device is not substantially equivalent to any currently being marketed. While de novo review has come under fire for being too complicated and time-consuming, the FDAs plan seeks to breathe new life into this underutilized process.

The FDAs review of medical devices through the 510(k) or PMA process is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.

On January, 7, 2011, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register, informing companies of its efforts to step up enforcement on unapproved cold and cough drugs. The targets of these enforcement efforts are unapproved drugs being marketed for the treatment of cough, cold, and allergies. Previously exempted from certain market approval requirements under the Drug Efficacy Study Implementation (DESI) program, these products are considered new drugs by the FDA.

When the Food Drug and Cosmetic Act (FD&C Act) was enacted, new drugs required approval before they could be legally marketed and sold. Generally, the FD&C Act requires new drugs to be approved for safety, which may be established by the submission of a new drug application (NDA), unless otherwise eligible for an over the counter (OTC) monograph. However, because of their similarities to approved prescription drugs and OTC drugs, several unapproved drugs were temporarily exempted from this process through the DESI program. Under this program, the FDA allowed these products to be marketed and sold until final DESI determinations were made.

With the recent notice published by the FDA, the Agency has announced changes that will affect all orally administered DESI cough, cold, or allergy drugs. First, the FDA announced that any interstate shipment of products with outstanding hearing requests that were withdrawn is now unlawful. Second, the FDA announced that it will consider any pending hearing requests withdrawn, unless companies specifically respond with the intention of pursuing their request. While the FDA specifically names certain firms in the notice, the enforcement efforts also apply to products that are identical, related, or similar (IRS) to those in the DESI program. Additionally, the Agency warns that no further notice will be given prior to commencing enforcement actions.

While this recent roundup of unapproved new drugs signals heightened enforcement by the FDA, these efforts are decades in the making. As illustrated in the Notice, the hearings for most of these drugs had either been withdrawn or pending since the 1980s. While we previously reported the FDAs intentions to step up enforcement in 2011, this recent action shows that the Agency is ready to clear out old matters, one industry at a time.

For more information on FDA enforcement measures or compliance, please contact us at contact@fidjlaw.com.

Recently, animal welfare advocates have been calling for the labeling of “humane” food.  On December 30, 2010, animal rights groups increased their efforts by updating their petition with the U.S. Department of Agriculture Food Safety Inspection Service (FSIS) and calling for rulemaking to standardize labeling requirements of eggs.  Specifically, the petition urges the USDA to standardize labeling requirements to alert consumers of the conditions under which food products have been produced.  Currently, a few major retailers, like Whole Foods, have signaled their support by announcing their intentions to inform interested consumers by adding signs indicating humanely-produced products in stores.

While there is no official word from the USDA regarding standardizing “humane” labels on eggs and other foods, this is not the only issue raised by consumer groups in regards to labeling.  The term “natural” has also come under scrutiny by consumer groups, as food companies are using this word to market their products to appeal to health-conscious consumers.  As we previously reported, a recent poll revealed that the majority of consumers were skeptical of the term “natural” being used on food labels and would like to see some uniformity regarding how “natural” is defined.  Similar to the use of “humane,” there is currently no standardized definition or certification process regarding the use of “natural” in labeling.  On the other hand, there is currently a certification process concerning the use of “organic” in labeling, which may only be used after several requirements are met.  Advocacy groups are calling for similar requirements to limit the use of “humane” and “cage-free” on food labels to those products that meet these kind of standards.

For more information about food labeling or USDA and FDA regulatory compliance, please contact us at contact@fidjlaw.com.

In what may be a sign that the FDA is loosening its grip on human embryonic stem cell (hESC) research, Advanced Cell Technology (ACT) announced that it has been cleared by the FDA to begin a new round of human clinical trials. The clinical trial will focus on developing a method to treat dry age-related macular degeneration, a condition that largely afflicts people over the age of sixty. According to ACT, previous trials using the therapy on animals have proven promising, showing “. . . a remarkable improvement in visual performance over untreated animals, without any adverse effects.”

With this recent FDA clearance, ACT is now the only company to have multiple hESC trials cleared by the FDA. As we previously reported, the FDA cleared the companys Investigational New Drug (IND) application in November, allowing ACT to begin a related clinical trial to treat a type of juvenile vision loss. In addition to these recently-cleared INDs, the FDA has cleared just one other hESC trial to date. In January 2009, Geron announced that the FDA had given initial clearance to allow the Company to proceed with clinical trials to treat patients with acute spinal cord injuries. While there are currently only three approved hESC clinical trials, these recent clearances may be an indication that the FDA is opening the door for further human embryonic stem cell research.

For more information on the FDA regulatory framework regarding stem cells or the Investigational New Drug process, please contact us at contact@fidjlaw.com.