FDA Modification to Dietary Supplement Qualified Health Claims Remanded by Federal Court

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During the first week in April, a federal judge granted the U.S. Food and Drug Administration (FDA) summary judgment in a federal case brought by dietary supplement manufacturers challenging good manufacturing practices (GMPs) for dietary supplements. During the second week in April, in a separate case, the win went to the dietary supplement manufacturers. On April 13, the U.S. District Court for the District of Columbia ruled that the FDAs decision requiring qualifying language for antioxidant claims for dietary supplements was unconstitutional under the First Amendment.

Dietary supplement formulators and industry organizations brought the lawsuit, Alliance for Natural Health US v. Sebelius, No. 09-1546 (D.D.C. April 13, 2011) (“Alliance II”), challenging an FDA decision to deny a petition for authorization of certain qualified health claims regarding dietary supplements containing vitamin C and vitamin E. The plaintiffs claimed that the FDA decision violated their First Amendment Rights and sought a declaratory judgment that the FDAs final order denying the petition was invalid. The plaintiffs also sought a permanent injunction enjoining the FDA from “taking any action that would preclude the Plaintiff from placing [their proposed] health claims on the labels and in the labeling of their dietary supplements.” Complaint at 36.

The health claims at issue in this case concerned the relationship between vitamins C and E and the risk for certain types of cancer. The FDA refused to approve these claims. A “health claim” is “any claim made on the label or labeling of a food, including a dietary supplement, that expressly or by implication, characterizes the relationship of any substance to a disease or health-related condition.” The FDA allows two types of health claims to appear on dietary supplement labeling: 1) authorized health claims; and 2) qualified health claims. A “qualified health claim” is a health claim that is supported by some scientific evidence but less evidence than an authorized health claim. The FDA requires that qualified health claims be accompanied by a disclaimer explaining the level of scientific evidence supporting the relationship between the dietary ingredient and the disease or health-related condition.

In Alliance II, the FDA required qualification of the following health claims:

  • Vitamin C may reduce the risk of gastric cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.
  • Vitamin E may reduce the risk of bladder cancer. The scientific evidence for this claim is convincing, but not conclusive.

The FDA prohibited the claims as they appear above and would only allow the claims to appear in the following forms:

  • One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer.
  • One small study suggests that Vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.

The plaintiffs brought their claims under the First Amendment to the Constitution. The Court reasoned that it “has the authority to examine and rule on any actions of a federal agency that allegedly violate the Constitution,” apart from the power of review granted by the Administrative Procedure Act (APA). Alliance for Natural Health USI v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010) (citations omitted) (“Alliance I”). However, the APA “also provides for the Courts to make an independent assessment of constitutional issues,” and the role of the Court is the same “whether the plaintiff sues directly under the Constitution or under [the APA].” Id. (citations omitted). Relying on the analysis set forth by Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (“Pearson I”) and by Alliance I, the Alliance II court reasoned that it “is obligated to conduct an independent review of the record and must do so without reliance on the [FDAs] determinations as to constitutional questions, it must also give deference to an agency assessment of scientific or technical data within its areas of expertise.” Id. at 16 (quoting Alliance I).

The Court described the appropriate inquiry in this matter to be “whether the FDA properly determined that there was no “credible evidence” supporting the plaintiffs claims.” Alliance II at 22. The Court stated that it would “limit its consideration of this question to an assessment of whether the FDAs evaluation was inconsistent with its own standards, irrational, or arbitrary and capricious. Id. The Court evaluated the FDAs 2009 Guidance Document stating that it uses an “evidence-based review system” to evaluate the strength of the evidence supporting a health claim and held the factors the FDA uses, as enumerated in the Guidance Document, to be reasonable and consistent with the FDAs regulatory authority. See id. at 24-25. However, when the Court evaluated the modifications applied to the plaintiffs qualified claims, the Court held that the FDA did not draft “precise disclaimer[s] designed to qualify plaintifss claim[s] while adhering to the ËœFirst Amendment preference for disclosure over suppression, as mandated.” Id. at 35 (citing Alliance I).

Ultimately, the Court held that the FDAs modifications to the claims were unconstitutional under the First Amendment. The FDA did not employ the least restrictive means available to regulate the speech at issue in this matter. The Court held that “health claims that are supported by some credible evidence, and which are therefore only potentially misleading, are protected commercial speechPearson I teaches that empirical evidence of the inefficacy of using disclaimers is required for the FDA to ban a health claim that is only potentially misleading “ i.e., a claim that is based on some credible evidence. Alliance II at 20.

The Court ruled that the FDA “has replaced plaintiffs claims entirely,” and that the claim “qualification effectively negates any relationship between cancer risk and vitamin intake. The FDAs rewordingmakes it difficult to tell what the original health claims are and appears to disavow the FDAs own conclusions that those claims are supported by credible evidence.” Alliance II at 13. The Court remanded the claims regarding the relationships between vitamin C and gastric cancer and vitamin E and bladder cancer to the FDA for further action.

Michigan lawmakers stir controversy proposing State Universities to report stem-cell use

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The debate on stem cells continues to raise controversy and impact science and discovery. The latest twist involves Michigan state lawmakers who recently proposed requiring each state public university to report on stem cell use. Michigan has 15 state funded universities. Specifically, under the proposed bill, each university would report the following to the Director of the Michigan Department of Community Health by December 1, 2011:

(a) The number of human embryos and the number of human embryo stem cell lines received by the university during fiscal year 2010-2011.

(b) The number of human embryos utilized for research purposes during fiscal year 2010-2011.

(c) The number of human embryo stem cell lines created from the embryos received during fiscal year 2010-2011.

(d) The number of donated human embryos being held in storage by the university as of September 30, 2011.

(e) The number of research projects using human embryonic stem cells derived from donated embryos being conducted by the university.

The proposal is enmeshed in the states 2011-2012 Higher Education Budget bill, commonly referred to as its “template” or “place-holder,” under the section of University Operations. The appropriations bill, House Bill 4275, was introduced by State Representative Robert Genetski (R) on February 16, 2011 and passed along a party line vote by the Higher Education Subcommittee on April 13th, 2011. Enactment of the bill still requires approval from the House Appropriations Committee, the full legislature and the Governors signature.

The bill is seen as controversial, not necessarily for what is imposed, but the impact of such imposition. The state seems justified requiring its funded institutions to report activity such as stem cell research; however, the requirement may be an objectionable regulatory burden intended to impede the research and discovery process. Michigans State Constitution is one of the few that specifically address embryonic stem cell research outlining a number of requirements to conduct research on embryonic stem cells. Fuerst Ittleman continues to actively investigate the evolving regulatory framework involving stem cell therapies. Contact our attorneys by emailing us at contact@fidjlaw.com for information on stem cell law and regulation.

Thanks to David Jesse, Higher Education Reporter, Detroit Free Press for access to the proposed bill.

Former GlaxoSmithKline in house counsel re-indicted

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On March 23, 2011, U.S. District Judge Roger Titus dismissed the indictment of former in house counsel Lauren Stevens due to concerns that the prosecutors erroneously advised the grand jury regarding the advice of counsel defense. We originally blogged about this prosecution here and here.

Under certain circumstances, it is a defense to a charge of willful criminal conduct that the defendant relied on the advice of a lawyer in committing the offense. This reliance on the advice of counsel negates the defendants specific intent to violate the law. When Judge Titus raised the concern that the prosecutors may have improperly advised the grand jury regarding the defense, Judge Titus dismissed the indictment without prejudice, and allowed the government to re-indict Stevens.

The Government re-indicted Stevens shortly thereafter. On April 14, 2011, a different grand jury re-indicted Stevens on six counts that she allegedly obstructed justice, made false statements to the FDA and concealed and falsified documents in regard to a federal investigation, essentially the same charges with which she was originally indicted. Trial is scheduled for April 26, 2011.

FDA Commissioner Testifies on FDA’s Screening Efforts at the Border

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On April 13, 2011, U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg testified before the U.S. House of Representative Energy and Commerce Subcommittee on Oversight and Investigations regarding the Agencys implementation of the new Predictive Risk-Based Evaluation for Dynamic Import Compliance Testing (PREDICT). PREDICT is a Web-based system designed to target inspections strategically based on risk factors chosen by the FDA.

Using an FDA-regulated products historical data, importer, manufacturer, country of origin, and any inspection and laboratory results, PREDICT will generate a numerical score for the product when it comes into port. It will also track information related to natural disasters and foreign recalls. It is intended to flag highest-risk items by notifying FDA inspectors at the port if a products PREDICT number is above an FDA-specified threshold. The FDA inspectors can then detain, examine, or refuse the product entry into the United States.

The Subcommittee noted in an internal memo, “[t]he sheer volume of imports precludes the FDA from inspecting more than two percent of the products under its jurisdiction before they enter into U.S. commerce.” In fact, between 15 and 20 percent of food consumed in the United States is imported. PREDICT was submitted to the FDA in 2005 to assist the FDA with identifying higher risk products at ports of entry. Since 2005, the FDA has only implemented the system in four districts”Los Angeles, New York, San Francisco, and Seattle.

Subcommittee members pointed out that at the rate FDA is putting PREDICT into effect in the field, it would take over five years to get it up and running in all 20 districts. Commissioner Hamburg stated that “technical difficulties” with the PREDICT system had been resolved and “back on track.” She further added, “[i]f successful, it will then be rolled out across the country.” FDA staff have assured congressional aides that Florida and Puerto Rico ports will be using PREDICT by the end of the month.

Hamburg testified as to the challenges and complexities that the FDA face and explained that, “[t]his year we expect nearly 24 million shipments of food, devices, drugs, cosmetics, radiation-emitting products, and tobacco products will arrive at U.S. ports of entry.” She added, “[j]ust a decade ago, that number was closer to 6 million, and a decade before only a fraction of that.”

Subcommittee Chairman Cliff Stearns (R-FL) stated, “I dont see any reason not to push more aggressively for [PREDICTs] immediate deployment nationwide. I also expect to have the Commissioner back here before the Committee at a future time to comment on the progress of PREDICTs deployment.”

We will continue to monitor the FDAs progress implementing PREDICT nationwide. For more information on importing FDA products or the PREDICT system, please contact us at contact@fidjlaw.com.

More Medical Device Hearings in Congress Scheduled for This Week

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Hearings in both the House and the Senate will take place this week to discuss the U.S. Food and Drug Administrations (FDA) medical device approval and clearance processes. The purpose of these hearings will be to examine how the medical device industry interacts and communicates with the FDA medical device regulators.

On April 13, the Senate Special Committee on Aging will hear “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process.” At this time, no agenda or witness list has been provided.

The House Oversight and Government Reform Subcommittee on Health Care will hold a hearing entitled “Pathway to FDA Medical Device Approval: Is There a Better Way?” on April 14. Dr. Jeffery Shuren, the director for the FDAs Center for Devices and Radiological Health (CDRH) will be one witness at this hearing.

These two hearings will be the second round to take place over the last two months examining FDAs medical device approval and clearance processes and proposed medical device process reform.

Summary Judgment Granted to FDA in Challenge to Dietary Supplement Good Manufacturing Practices

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The U.S. District Court for the District of Columbia granted summary judgment for the U.S. Food and Drug Administration (FDA) in a case challenging good manufacturing practice (GMP) regulations for dietary supplements. The order, dated April 6, 2011, can be found here.

In the case Alliance for Natural Health U.S. v. Sebelius, No. 09-1523, 2011 U.S. Dist. LEXIS 37027 (D.D.C. April 6, 2011), the plaintiffs include Sandy Shaw and Duke Pearson, scientists who formulate dietary supplements and license the formulations to dietary supplement distributors and manufacturers. Other plaintiffs to the lawsuit include industry organizations, Alliance for Natural Health USA and the Coalition to End FDA and FTC Censorship. The plaintiffs sought to have various provisions of the dietary supplement GMPs declared invalid and to have the enforcement of the GMPs enjoined. The FDAs dietary supplement GMP regulations and guidance documents can be found here.

The plaintiffs challenges to the GMP regulations included the following:

1) That several GMP regulations went beyond the statutory authority of the FDA to regulate dietary supplements;

2) Some of the GMP regulations were unconstitutionally vague and in violation of the Fifth Amendments Due Process Clause; and

3) Due to the vague sections of the GMP regulations, these regulations were arbitrary and capricious and an abuse of the FDAs discretion under the Administrative Procedure Act (APA).

The plaintiffs asserted that under Section 402(g) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 342(g)), the FDA is prohibited from issuing GMP regulations that “impose Ëœstandards for which there is no current and generally available analytical methodology.”

In Judge Beryl Howells order, the court explains that “the plaintiffs read this clause to mean that the FDA is only permitted to issue GMP regulations that are based on analytical methodologies and that these methodologies must also be current and generally available” while on the other side “the FDA reads the clause to mean that if and when the FDA issues a regulation that incorporates a standard based on an analytical methodology, then that analytical methodology must be one that is current and generally available.”

The court first stated that the plaintiffs were precluded from contesting the FDAs regulatory authority because the plaintiffs had failed to raise this issue during the rulemaking process. The court then proceeded to evaluate the plaintiffs challenges to the the FDAs statutory authority using the two-step analysis of Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). Under the first step of Chevron, the court analyzed the text of the FDCA, as well as the structure and legislative history, and “conclude[d] that the clear meaning of Section 402(g) is the FDAs interpretation of the statute.” The court stated that once “the FDA imposes a standard that requires the use of an analytical methodology, the methodology must be current and generally available to manufactures. The statute does not mean that the FDA may only adopt GMP regulations that require the use of such an analytical methodology.”

The court went on with the second step of its Chevron assessment and found, quoting Chevron, that “if a statute is ambiguous with respect to a specific issue, the Court must uphold the agencys interpretation if it is Ëœbased on a permissible construction of the statute.” Under the two steps of the Chevron analysis, the court held that it “could not conclude that the FDAs construction of the statute is impermissible.”

The court went on to address the plaintiffs contention that certain GMP regulations are unconstitutionally vague by stating that, while certain words are not defined in the GMPs (like “adequate,” “suitable,” “qualified,” etc.), the regulations explain the terms by providing “numerous details clarifying what the FDA means.” The court ultimately concluded that the regulations are not facially unconstitutional and “are not arbitrary and capricious under the APA.”

FDA Issues Nutritional Labeling Proposed Rule

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The U.S. Food and Drug Administration (FDA) has just issued two proposed rules involving a provision of the Patient Protection and Affordable Care Act (“PPACA”), the 2010 Healthcare Reform Law, which requires certain food establishments and vending machines to post caloric and nutritional information on menus, including drive-thru windows. As we have previously blogged (here, here, here, and here) this provision amends the Federal Food, Drug, and Cosmetic Act (“FDCA”) in attempt to provide uniformity in menu nutritional labeling around the country and to assist consumers in making healthier food choices while eating out.

Under the PPACA, restaurants, bakeries, grocery stores, convenience stores, coffee shops and other establishments with 20 or more locations operating under the same name and offering for sale substantially the same food items are required to post caloric information directly on the menu and have nutritional information available upon request. Under the proposed rule, the calorie declaration must be “adjacent to” the name of the standard menu item, so as to be “clearly associated with” it. For standard menu items that come in different flavors, varieties, or combinations but are listed as a single menu item, such as combination meals or ice cream that comes in different flavors, the FDA is proposing allowing calorie ranges as opposed to median (middlemost) or mean (statistical average) calories. Self-service establishments such as buffets and cafeterias must display the caloric information on a sign adjacent to the food.

The PPACA requires that menus post a clear and conspicuous statement regarding the availability of nutrition information upon request. Under the proposed rule, this statement must be no smaller than the smallest type size for any calorie declaration, be on the first page of the menu, and be prominently displayed (i.e., the same color and contrasting background as the standard menu item).

Additionally, a succinct statement concerning the total daily suggested caloric intake must be prominently displayed “to enable the public to understand…the context.” An example of this statement is “A 2,000 calorie daily diet is used as the basis for general nutrition advice; however, individual calorie needs may vary.” The FDA has been using the 2,000 calorie reference point since at least 1993. The proposed rule requires this statement on the bottom page of each page of the menu.

We previously blogged regarding whether movie theaters would be covered under the proposed rule. In the proposed rule, movie theatres, amusement parks, bowling alleys, trains, airplanes, general merchandisers, hotels and other business operations who do not primarily sell food items are generally exempted from the nutritional labeling requirements.

For vending machines, the proposed rule requires that caloric information be posted adjacent to the vending machine, but not necessarily attached to the vending machine. The number of calories contained in the article should be expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories. Foods that have fewer than 5 calories may be expressed as zero. For vending machines that sell varieties, such as different flavors and types of hot beverages (e.g., coffee), caloric information should be listed for each flavor or variety in close proximity to each selection rather than posting a single range for the item.

Only vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines are covered under the PPACA. It is believed that 90-95 percent of vending machine operators have 20 or more machines, and therefore, will be included.

Any food establishment or vending machine operator not covered under the PPACA may voluntarily participate and register with the FDA every two years. Interestingly, the posting of calories and nutritional information for beer, wine, and other alcoholic beverages is exempt. Food not in compliance with the final rule will be deemed misbranded under the act and subject to FDA enforcement.

The FDA is seeking comments on the proposed rules. The comment period for the proposed rule for menu labeling is 60 days (until June 6, 2011), and comments on the proposed rule on vending machines is 90 days (until July 5, 2011). Once implemented, these rules will preempt state and local food labeling requirements for restaurants, similar retail food establishments, and vending machines that are covered under the proposed rules. Establishments not covered under PPACA and the proposed rules will remain subject to existing state and local laws. The FDA plans to issue final rules before the end of the year and begin enforcement in 2012. For more information regarding the labeling of food products, the misbranding provisions of the FDCA, or how the PPACA will impact your business, please contact us at (305) 350-5690 or contact@fidjlaw.com.

Shutdown Will “Severely” Limit FDA Inspections

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A U.S. Food and Drug Administration (FDA) official told CNN on Thursday that a shutdown of the federal government will severely restrict FDA inspections. The FDA has announced that it will furlough 86% of its staff and that 1,962 of its approximately 13,000 staff members will continue working. All drug and device reviews and all public meets will be canceled in the event of a shutdown. Food importation inspections will continue without interruption.

The FDAs Office of Regulatory Affairs (ORA) is responsible for food inspections and will not be operating with its full staff should the shutdown occur. The ORA will have some inspectors on staff next week in the event that a resolution regarding the budget is not reached. FDA inspections of drug manufacturing facilities and food processing plants will be conducted in order of the level of risk involved. Inspections of plants and facilities that are deemed “high risk” by the agency will be inspected in lieu of routine plant inspections. Facilities that are classified as “high risk” typically have a history of violations or significant safety concerns.

When a drug or medical device manufacturer files a new product or registration with the FDA, the FDA conducts an initial inspection. These initial inspections will not be conducted in the event of a shutdown and pending applications with the FDAs Center for Biologic Evaluation, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Center for Veterinary Medicine will be subject to delayed review. All of these centers will be operating at reduced staffing levels.

Should an emergency situation, such as a food borne illness outbreak, occur during a government shutdown, the FDA will recall the furloughed staff into action. The anonymous FDA official told CNN that the agencys monitoring of food products coming from Japan for possible radiation contamination will not be affected in the event of a shutdown.

Interestingly, of the agencys nine centers, only the Center for Tobacco Products will remain fully staffed should the shutdown occur. The Center for Tobacco Products is funded by the tobacco industry and will not be affected.

Government Persists with Efforts to End Marketing of “Cancer Cures”

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Continuing the Daniel Chapter One (DCO) saga, the Department of Justice (DOJ), on behalf of the Federal Trade Commission (FTC), has recently resumed its action against the dietary supplement distributor. DCOs troubles with the FTC began nearly three years ago when the FTC sought to enjoin the company from marketing its products as effective in curing cancer. According to the FTCs Final Order, DCO was prohibited from advertising its dietary supplements in this manner because it had no scientific evidence to support these claims. However, that was not the end of DCOs troubles.

At the direction of the FTC, the DOJ brought a complaint in 2010 for civil penalties, seeking to disgorge DCOs “ill-gotten” profits. According to DOJ, the Company continued marketing and selling its products in violation of the FTC Final Order. However, because DCO appealed the FTCs final order, this contempt action has been stalled pending the resolution of the remaining issues in the original FTC action. With DCOs appeal being denied, the stay has recently been lifted and the DOJ is continuing its efforts to stop the dietary supplement company from reaping the rewards of its deceptive advertising.

While it appears that DCO has its hands full with the FTC and DOJ, other federal agencies have pursued actions against the company as well. For instance, the U.S. Food and Drug Administration (FDA) and the Internal Revenue Service (IRS) have each targeted DCO in connection with its marketing and sales of these products. In August of 2008, the FDA issued a Warning Letter (found here) to Daniel Chapter One based on a review of the companys website. The Warning Letter stated that four of the companys products were “promoted for conditions that cause the products to be drugs . . .” and the marketing of these products was a violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the Warning Letter pointed out claims describing the ingredients of the products, as well claims in the form of testimonials. Many of these claims indicated that the products reduce the risk of cancer or that ingredients in the products are cancer-fighting or can inhibit tumors.

While the FTC, FDA, and IRS all have distinct areas of regulatory authority, as revealed by the case of Daniel Chapter One, their paths often cross. For more information regarding the jurisdictional overlap between FDA, IRS and FTC, please contact us at contact@fidjlaw.com.

FDA allows Pharmacy Compounding of Preterm Labor Drug

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On Wednesday, March 30, 2011, the U.S. Food and Drug Administration (FDA) issued a statement to compounding pharmacies regarding FDAs enforcement discretion with regard to compounded versions of Makena┞¢, KV Pharmaceuticals branded preterm labor drug. As we previously reported, the FDA approved KV Pharmaceuticals Makena┞¢ (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women. After receiving approval, KV Pharmaceuticals began charging $1,500 a dose for a compound that had been available for years for approximately $10 to $20 a dose. The FDA statement is intended to neutralize the public outcry, not only from members of Congress, but from many doctors and medical groups over the huge price increase.

The FDA states that “KV Pharmaceuticals has sent letters to pharmacists indicating that the FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.” The FDA “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient [].” This statement goes against the FDAs policy on compounding pharmacies. In Compliance Policy Guide 460.200 on pharmacy compounding, the FDA states it will consider enforcement action when a pharmacy engages in compounding drug products that are commercially available in the marketplace. As a way to explain its change in position with regard to compounding pharmacies, the FDA states that it is not going to take enforcement action in an effort “to support access to this important drug, at this time and under this unique situation.”

Fuerst Ittleman will continue to monitor FDAs enforcement posture for Makena┞¢ and other compounded products. For more information, please contact us at contact@fidjlaw.com.