As required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), the U.S. Food and Drug Administration (FDA) issued a proposed rule on July 3, 2012 to establish a unique device identification (“UDI”) system for medical devices marketed in the U.S. The UDI system would require a unique code to appear on the label and package of a device in order to adequately identify the device through its distribution and use. The UDI system is expected to help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDAs proposed rule can be read here.

Under the proposed rule, the UDI is composed of (1) a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and (2) a production identifier, which includes current production information for a device. The proposed rule also requires device manufacturers to submit device information into the publicly available Global Unique Device Identification Database (“GUDID”). GUDID will include a standard set of basic identifying elements for each UDI. The UDI does not indicate, and GUDID will not contain, any information about who uses a device, including personal privacy information.

The proposed rule implements the UDI system through a multi-year risk-based, phased-in approach, focusing on highest-risk medical devices first and exempting low-risk devices from some or all requirements. Exempt devices include:

• Over-the-counter devices sold at retail which have UPC codes;
• Devices delivered directly to hospitals and other health care facilities;
• Class I devices exempted by regulation from the Quality Systems Requirements in 21 C.F.R. 820;
• Products used solely for research, teaching, or chemical analysis and not intended for any clinical use;
• Custom devices;
• Investigational devices;
• Veterinary medical devices;
• Devices intended for export;
• Devices held by the Strategic National Stockpile; and
• Devices for which FDA has established a performance standard.

Once fully implemented, the FDA states that the UDI system will provide multiple benefits, including:

• Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
• Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
• Provide a consistent way to enter information about devices in electronic health records and clinical information systems.
• Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
• Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.

The proposed rule could significantly impact medical device labelers, including manufacturers, reprocessors, and repackagers. Specifically, these labelers will bear the brunt of the cost of implementing the new UDI system. The FDA estimates that the majority of the cost of the proposed rule would be incurred by domestic labelers. Domestic labelers are estimated to spend $588.6 million over the next 10 years to implement the UDI system. The largest component of the estimated cost includes the costs to integrate the UDI system into existing information systems. Other significant components of the cost include costs to redesign device labels to incorporate the required UDI information.

The FDA is currently seeking public comment on the proposed rule for the UDI system (Docket No. FDA-2011-N-0090). Fuerst Ittleman will continue to monitor the developments and changes to the FDAs medical device regulation. For more information, please contact us at contact@fidjlaw.com.

On June 26, 2012, the U.S. Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act by a 92-4 vote, which the U.S. House of Representatives passed on June 20, 2012 by a voice vote. The FDA Safety and Innovation Act will provide more than $6 billion in industry user fees to the FDA over the next five years to fund the Agencys review of new drugs and medical devices. The full text of the FDA Safety and Innovation Act can found here.

Although the FDA receives money from Congress each year, a large portion of the Agencys budget comes from user fees it receives from manufacturers of drugs and medical devices. Under the new legislation, the FDA is expected to collect $693 million from drug manufacturers through next year, and $595 million from medical device manufacturers through 2017. Consequently, the Congressional Budget Office projects that the legislation will reduce federal spending by $311 million over the next 10 years.

The additional funds will enable the FDA to more quickly review new drugs and medical devices. Therefore, the legislation is expected to help the FDA bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs.

Fuerst Ittleman will continue to monitor the legislation as it is enacted and implemented. For more information about the FDA Safety and Innovation Act or FDA regulatory compliance, please contact us at contact@fidjlaw.com.

For years, the Corn Refiners Association (CRA), a national trade association representing the corn refining industry, has promoted the rebranding and name change of high fructose corn syrup (HFCS) to “corn sugar.” The CRA suggests that many consumers are confused and misled by the ingredient name HFCS. CRA proposes that, as an alternative to HFCS, the name “corn sugar” more closely reflects reasonable consumer expectations and more accurately describes the ingredient. The CRAs rebranding efforts have included filing a citizen petition with the U.S. Food and Drug Administration (FDA) and launching a multi-million dollar advertising campaign.

 Citizen Petition

In September 2010, the CRA filed a citizen petition with the FDA requesting that the Agency recognize “corn sugar” as an alternate common or usual name for HFCS as an ingredient on food labels. However, on May 30, 2012, the FDA denied the petition stating that the CRA “does not provide sufficient grounds for the Agency to authorize ‘corn sugar’ as an alternate common or usual name for HFCS.”
In its denial of the citizen petition, the FDA stated that the proposed name does not fully satisfy the criteria for common or usual names of foods. Common or usual names of foods must identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties. 21 C.F.R. 102.5(a). “Sugar” is permitted as part of the name for foods that are solid, dried, and crystallized. HFCS is a syrup, a liquid or aqueous solution, derived form corn. Thus, the use of the term Ëœsugar to describe HFCS, a product that is a syrup, would not accurately identify or describe the basic nature of HFCS or its characterizing properties.
Additionally, the CRA petitioned the FDA to amend the common or usual name established by regulation for dextrose monohydrate, eliminating “corn sugar” as an alternative name. 21 C.F.R. 168.111. The petition argued that consumers do not commonly associate the term “corn sugar” with dextrose. Not persuaded by this argument, the FDA stated that scientific literature and various public websites often use the term “corn sugar” to describe dextrose.

Furthermore, the FDA voiced concern that changing the name for HFCS to “corn sugar” could pose a public health risk. Individuals with hereditary fructose intolerance or fructose malabsorption avoid consuming ingredients that contain fructose. These individuals associate “corn sugar” with dextrose, which is an acceptable ingredient for their health, as opposed to fructose which is not. Therefore, changing the name for corn sugar could put these individuals at risk.    

Advertising Campaign Lawsuit

In 2008, the CRA launched a multi-million dollar advertising campaign in order to rebrand HFCS as “corn sugar” in the eyes of consumers. The advertisements claimed that “sugar is sugar” and “your body cant tell the difference” between HFCS and natural sugar.

The advertising campaign is the basis of an ongoing federal lawsuit filed by the sugar industry in April 2011. In the suit against the CRA, the sugar industry alleged that the advertising campaign is false and misleading, and violative of Section 43(a) of the Lanham Act. 15 U.S.C. § 1125(a). The complaint states that representations that HFCS and sugar are metabolically and nutritionally the same are literally false or, at best, reckless and misleading. In support of the allegation, the sugar industry points to the molecular differences between the free-floating monosaccharides fructose and glucose in HFCS and the bonded disaccharide sucrose in sugar. In order to demonstrate the nutritional difference, the complaint cited to a Princeton study which found a causal link between HFCS consumption and health problems that are not equally presented by the consumption of sugar.      

Fuerst Ittleman will continue to monitor the Courts decision and developments in the regulation of sugar and food products. For more information, please contact us at contact@fidjlaw.com. 

On May 23, 2012, Judge Donald Middlebrooks of the United States District Court for the Southern District of Florida issued an order denying the Federal Trade Commission’s (“FTC”) motion to modify a consent decree entered between it and dietary supplement manufacturer Garden of Life (“GOL”) regarding what qualifies as “competent and reliable scientific evidence” for the substantiation of health and disease related claims made on GOL’s dietary supplement products. The Court’s order comes as the FTC has made increased efforts at requiring a heightened level of substantiation for health related claims. Under this heightened substantiation level, dietary supplement manufacturers must support their claims with “two well-controlled human clinical studies.” A copy of the Court’s order can be read here.

The FTC requires that claims made by dietary supplement manufacturers be both truthful and not misleading. In addition, the FTC requires that manufacturers possess “competent and reliable scientific evidence” to support all health related claims. However, the definition of “competent and reliable scientific evidence” has been under increasing debate and scrutiny. Over the past several years, dietary supplement manufacturers have had to wrangle with the Federal Trade Commission’s attempts to redefine and enforce a heightened level of substantiation for health related claims. (Our previous reports on the FTC’s efforts can be read here, here, and here.) Such was the case in the Garden of Life litigation.

The GOL litigation stems from a consent decree entered into by the FTC and GOL regarding the health related claims used in the advertising of GOL’s dietary supplement products. The consent decree prohibited GOL from making any representations: 1) that its products mitigate, treat, prevent, or cure any disease or illness; or 2) about the absolute or comparative health benefits of its products, unless GOL possessed “competent and reliable scientific evidence” to substantiate such claims. “Competent and reliable scientific evidence” is defined in the Order as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

However, in its motion, the FTC sought to modify the consent decree by changing the definition of “competent and reliable scientific evidence” to require: 1) “two adequate and well-controlled human clinical studies for all absolute or comparative claims” about the cognitive health benefits of GOL’s products; and 2) FDA approval for all “disease treatment and cure claims” of GOL’s products.

Generally speaking, when seeking to modify a consent decree, the moving party must demonstrate: 1) that a significant change either in factual conditions or in the law has occurred; and 2) that the proposed modifications are suitably tailored to the changed circumstances. See Sierra Club v. Meiberg, 296 F.3d 1021, 1033 (11th Cir. 2002). Here, as a basis for the proposed modifications, the FTC argued that because the consent decreed failed “to achieve its intended purpose of protecting consumers from GOL’s ‘deceptive marketing,’” a significant change in factual circumstances had occurred which warranted the court modifying the consent decree. Order at 7.

In rejecting the FTC’s position, the Court noted several things. First, the Court found that “consent decrees generally do not have overarching purposes” such as consumer protection. Instead, consent decrees are typically the product of negotiation between the parties. Thus, the actually negotiated purpose of a consent decree is usually far more limited. The Court found that such was the case here. Thus, “the decree cannot be interpreted as requiring whatever might be necessary and appropriate to achieve [consumer protection] because it was not written that way.” Order at 8 (citing Sierra Club, 296 F.3d at 1031-1032).

Second, the Court found that a mere disagreement between the FTC and GOL over the definition of “competent and reliable scientific evidence” is not sufficient for the Court to assert its authority to modify the consent decree. “The fact that the FTC is no longer satisfied in 2012 with the definition it agreed to during negotiations with GOL in 2006 does not constitute a significant change in factual circumstances.”Order at 9. The Court went on to find that given the broad definition of “competent and reliable scientific evidence” as set forth in the consent decree, the FTC should have anticipated that parties would disagree over what evidence and procedures qualify and therefore should have sought to limit such a definition at the consent decree’s inception. Id at 9-10.

For more information on FTC regulations and substantiation requirements, or on how to ensure that your business maintains regulatory compliance at both the state and federal levels, please contact us at contact@fidjlaw.com.