FDA Considering Enhanced Regulation or Ban On Menthol Cigarettes

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With the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, (“Tobacco Act”) Congress granted the FDA the authority to regulate all tobacco products marketed within the United States. As part of this expansion of FDA jurisdiction, Congress required the FDA to establish the Tobacco Products Scientific Advisory Committee (“Tobacco Committee”) to provide the FDA with “advice, information and recommendations” regarding the regulation of tobacco in conformance with the Act. Additionally, the Tobacco Committee was charged with studying and issuing a report on the impact of the use of menthol in cigarettes on the public health and recommendations for regulations to develop “a tobacco product standard is appropriate for the protection of the public health.”

In preparation for its full release, the Tobacco Committee has released its draft report, available here, giving insight into possible recommendations. Though the Tobacco Committees draft report reaches the conclusion that “evidence is insufficient to conclude that smokers of menthol cigarettes face a different risk of tobacco-caused diseases than smokers of non-menthol cigarettes,” the report also found that “menthol has cooling and anesthetic effects that reduce the harshness of cigarette smoke” and that “the evidence is sufficient to conclude that it is biological[ly] plausible that menthol makes cigarette smoking more addictive.” As a result of the report, possible recommendations include reduction in the amount of menthol in cigarettes or even a total ban on the use of menthol in cigarettes in order to help make cigarettes less addictive or palatable.

On March 23, 2011, the FDAs Tobacco Products Scientific Advisory Committee is due to submit its report and recommendations to the FDA regarding the health effects of menthol cigarettes. However, two menthol cigarette manufacturers, Lorillard and R.J. Reynolds filed suit to block the committees recommendations. The suit alleges that the committee cannot provide fair advice because three of its members have conflicts of interests, which are expressly prohibited under the Tobacco Act.

The potential ban on menthol cigarettes comes after a 13 year battle over whether the FDA had jurisdiction to regulate cigarettes culminating with Congresss passage of the Tobacco Act of 2009. The battle for jurisdiction to regulate cigarettes began in 1996 when the FDA attempted to regulate cigarettes as drug/device combination products under its authority in the Food, Drug, and Cosmetic Act (“FDCA”). Prior to this time, the FDA asserted that it could only regulate tobacco products under the FDCA if they were sold for “therapeutic uses,” i.e. use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” under 21 U.S.C. § 321(g)(1)(B) of the FDCA. In FDA v. Brown & Williamson, 529 U.S. 120 (2000), the Supreme Court rejected the FDAs argument that the FDCA gave it authority to regulate tobacco products that made no “therapeutic claims” under the FDCA.

As a result of regulatory gap left by Brown & Williamson, Congress passed the Tobacco Act in 2009 to grant FDA the authority to regulate tobacco products as traditionally marketed. However, even with the passage of the Tobacco Act, FDA has still attempted to regulate tobacco products under the FDCA. As we previously reported, on December 7, 2010, the D.C. Circuit Court issued an injunction against the FDA and ruled that the FDA did not have jurisdiction to regulate e-cigarettes under the FDCAs drug/device provisions.

On December 7, 2010, FDAs jurisdiction to regulate tobacco products was summarized by the D.C. Circuit in NJOY v. FDA: 1) Together Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCAs drug/device provisions; however, 2) the FDA can regulate tobacco products marketed for therapeutic purposes under the FDCA, and 3) the FDA can regulate customarily marketed tobacco products under the Tobacco Act.

It is important to note that tobacco product regulation in the United States also involves the U.S. Customs and Border Protection (CBP) and the U.S. Department of the Treasury, Alcohol, Tobacco, Tax and Trade Bureau (TTB). Additionally, the Department of Justice, Office of Consumer Litigation (OCL) regulates Cigarette labeling and advertising, and the Bureau of Alcohol, Tobacco, and Firearms (ATF) investigates and enforces interstate trafficking of contraband cigarettes. State laws may also be implicated.

Experienced attorneys at FI can help establish calculation of duty including excise taxes and user fees, ensure compliance with invoice, permit, and recordkeeping requirements, ensure legal labeling and product packaging and defend action administrative actions and litigation. If you have questions pertaining to the FDCA or the Tobacco Act or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at contact@fidjlaw.com.

FDA To Take Over Three Tylenol Manufacturing Plants As Part Of Consent Decree

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On March 10, 2011, the FDA in cooperation with the Department of Justice announced that a consent decree had been filed against McNeil PPC (“McNeil”) and two of its executives for failing to comply with current good manufacturing practice (“cGMP”) regulations. In accordance with the consent decree, McNeil, a division of Johnson & Johnson, has agreed to place three of its Tylenol manufacturing plants, in Puerto Rico, Lancaster, Pa. and Fort Washington, Pa., under FDA supervision. A copy of FDAs press release can be read here.

The consent decree comes after numerous FDA inspections of the three facilities between 2009 and 2010 revealed violations of the Food, Drug, and Cosmetic Act (“FDCA”) and cGMP regulations. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the FDCA. More information regarding cGMPs is available at FDAs website. These cGMP violations resulted in McNeil issuing extensive product recalls for the over-the-counter drugs its plants produced, including Tylenol, Motrin, and Benadryl in May 2010.

The consent decree requires McNeil to adhere to a strict timetable for bringing its facilities into compliance. Under the terms of the consent decree filed by the Department of Justice in the Eastern District of Pennsylvania, McNeil is required to destroy all drugs under its control that have been recalled from the three facilities since December 2009. Additionally, McNeil must retain independent experts to inspect the three facilities to determine whether the violations have been corrected and to ensure that adequate manufacturing processes are in place. Upon expert certification, the FDA will then determine if the facilities are in compliance.

If McNeil violates the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective actions including fines of $15,000 per day per violation of law up to $10 million annually. If you have questions pertaining to the FDCA or cGMP regulations or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at contact@fidjlaw.com.

New Test Shortens Time for Determining Pluripotency of Stem Cells

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In a study published this week, researchers at Scripps Research Institute in La Jolla, California have released findings that could solve a major issue that scientists have faced when developing stem cell therapies.  Currently, one of the main issues that has troubled researchers has been the lengthy process of testing pluripotency.  Pluripotency is the ability of a cell to become any kind of cell in the body.  While one major advantage of embryonic stem cells is the ability to develop into different types of cells, other concerns have stifled their use, and researchers have had to develop means to reprogram mature cells to harness the capabilities of embryonic stem cells.  However, a major drawback of these methods is determining whether the reprogrammed cells are truly pluripotent.  Click here to read about a recent legal challenge to federal funding of embryonic stem cell research. 

While the current test used by researchers to check pluripotency takes approximately six to eight weeks, researchers have recently found a new way to test whether a stem cell is pluripotent.  The new method, known as the PluriTest, dramatically decreases the time to check pluripotency and may be completed in as little as ten minutes.  With the development of this new means of testing pluripotency, researchers may have one less roadblock in the development of stem cell therapies. 

More information on FDA news on stem cells can be found here.  Our recent reports on the trials and tribulations of stem cell research and procedures can be found here.

FDA Takes Cooperation with FTC to a New Level

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On February 1, 2011, the U.S. Food and Drug Administration (FDA) has cited a dietary supplement manufacturer for violating not only the Food, Drug & Cosmetic Act (FD&C Act) that it has traditionally enforced, but the Federal Trade Commission Act (FTC Act), enforced by the FTC.

The similarities between the FD&C Act and the FTC Act have led the FDA and FTC to frequently engage in cooperative efforts, as the FD&C Act mandates that advertising be truthful and non-misleading and the FTC Act prohibits deceptive practices in commercial activities. Although there is some overlap in jurisdiction between these agencies pursuant to the obligations imposed by statute, this recent action raises the question of whether the FDA has stepped outside its Congressionally-authorized jurisdiction by actually enforcing the FTC Act.

While this recent FDA action goes beyond previous cooperative efforts with the FTC, this is not the first time the FDA has warned a company that it may be in violation of the laws that the FTC enforces. The FDA and FTC frequently work together. For example, in “Operation Cure All” the agencies teamed up to combat internet marketing of health products that claimed cures for various diseases without the requisite level of substantiation. Additionally, as far back as 2004 the FDA has referenced the FTC in its warning letters to companies. However, in one such letter, the FDA only warned of possible violations of the FTC Act and alerted the company that it was forwarding the letter to the FTC. The most recent Warning Letter goes far beyond this kind of notice. The Warning Letter requires the company receiving the violation to send a response to the FTC, an agency wholly separate from the FDA and charged with the task of enforcing distinct legislation.

Due to the overlapping jurisdiction of the FTC and the FDA, some points of conflicting policy often arise. One example of such conflict is in the area of dietary supplement claim substantiation. But the FTC and the FDA share jurisdiction over dietary supplement regulation, with the FDA maintaining responsibility for the labels and “point of sale” materials (like brochures, pamphlets, etc.) of dietary supplements and the FTC bearing responsibility for all dietary supplement advertisements (including websites, print and TV ads, etc.). However, the FDA will look at advertisements like product websites when determining the compliance of the product under the FD&C Act. Likewise, the FTC will examine claims appearing on product labels when evaluating dietary supplement compliance under the FTC Act.

This overlapping dietary supplement jurisdiction becomes even more complicated when it comes to the two agencies requirements for substantiation of claims. Both agencies require that claims be “truthful and not misleading.” The FTC purports to require “competent and reliable scientific evidence” to support such claims and the FDA supports this level of substantiation as well. However, as we have reported recently, the food manufacturer, POM Wonderful, LLC, has claimed that the FTC has been utilizing a new standard for substantiation in its enforcement action. This “new standard” is reflected in two published consent orders against Nestle USA and Iovate Health Sciences, Inc., in which the FTC prohibited future claims by the companies unless the claims are supported by two well-controlled, human clinical studies. The “new standard,” if POM is correct, marks a drastic change in FTC policy regarding substantiation of claims. This “new standard” is stark contrast to the FDAs policy on claims substantiation. The FDA requires competent and reliable scientific evidence to support every reasonable interpretation of a claim. Further, under section 201(ff)(3)(B)(ii) of the FD&C Act, a product is NOT a dietary supplement if it is an article authorized as a new drug for which substantial clinical investigations have begun and are announced to the public. Therefore, it is possible that a dietary supplement required to meet the FTCs alleged “new standard” for substantiation could be deemed misbranded and an unapproved new drug under the FD&C Act. While the full consequences of this “new standard” have yet to be seen, the dilemma for companies trying to maintain compliance without subjecting themselves to heightened regulation is looming.

The FTCs guidance on dietary supplement advertising can be found here. The FDAs guidance on dietary supplement claims substantiation can be found here.

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

Court of Appeals Overturns Ruling Allowing FDA to Conduct Records Inspections of Compounding Pharmacies

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On February 25, 2011, the United States Court of Appeals for the Fifth Circuit vacated a ruling of the United States District Court for the  Western District of Texas which held that the FDA could conduct limited inspections of pharmacy records to determine if pharmacy-compounded drugs comply with the conditions set forth in the Food, Drug  & Cosmetic Act (“FDCA”). The Fifth Circuits opinion may be read here.

This case arose from a 2005 lawsuit filed by a group of pharmacies against the FDA challenging the authority of the FDA to regulate compounded drugs under the FDCA. The District Court ruled in  favor of the pharmacies, declaring that compounded drugs were exempt from new drug definitions and from the new drug approval processes.  Also, it ruled that under the FDCA, if a pharmacy is compliant with local laws, dispenses drugs pursuant to a prescription, and compounds in the regular course of its own business, the pharmacy is exempt from FDA records inspections.

The FDA appealed the District Courts ruling that compounds were exempt from the definition of new drugs under the FDCA, but not the ruling that compliant pharmacies were exempt from FDA records inspections. The Court of Appeals reversed the District Courts ruling on the new drug issue, holding instead that compounded drugs were “new” drugs under the FDCA, but were exempt from the FDCAs substantive provisions if they comply with the conditions of Sections 353a and 360b(a). On remand, the District Court entered a new judgment that declared that the FDA had the statutory authority to conduct limited inspections of pharmacy records to determine whether drugs compounded by pharmacies are exempt from the provisions of the FDCA.

The pharmacies then appealed this new District Court ruling, arguing that by failing to appeal the District Courts first inspection declaration, FDA forfeited the inspection issue. On appeal, the Court of Appeals ruled in favor of the pharmacies, finding that since the FDA did not appeal the District Courts original ruling that compounding pharmacies were exempt from FDA records inspection, the FDA forfeited the issue, and therefore, the District Court violated the “waiver doctrine” by reconsidering the inspection issue. The District Courts ruling that FDA could conduct limited records inspections of compounding pharmacies was thus vacated.

The applicability of many provisions of the FDCA to compounding pharmacies is complicated. With a primary focus of the FDCA being federal regulation of drug manufacturers, the application of these regulations to compounding pharmacies may be inappropriate.

Under the FDCA and its enforcing regulations, drug manufacturers must comply with an extensive regulatory scheme, including the new drug approval process, misbranding provisions, and registration with the FDA.  Additionally, the FDA has the express authority to conduct field inspections of drug manufacturing facilities under the Act.  While it is unclear whether this provision applies to compounding pharmacies, Section 704 of the FDCA allows the FDA “to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce. . . .”  Based on this language, these provisions may only apply to compounding pharmacies if they are properly considered manufacturers of drugs that may be introduced into interstate commerce.  However, because of the FDAs failure to properly preserve the inspection issue, the Court of Appeals did not determine whether this provision applied and the District Courts original ruling that compounding pharmacies are exempt survives.

The issue of applying the FDCA and its enforcing regulations to compounding pharmacies and doctors is hotly-contested.  Typically applicable to manufacturers, Congress enacted the FDCA in an effort to oversee establishments that manufacture products affecting interstate commerce. However, the FDA has made repeated attempts to apply these restrictions to pharmacists and doctors, which have traditionally been seen as beyond FDAs jurisdiction.  Because Congress did not intend for the Act to regulate practitioners, who are generally regulated by the states, the FDAs regulation of the practice of pharmacy and the practice of medicine may be viewed as exceeding the scope of its authority.

FDA Announces Removal of Unapproved Cold, Cough, and Allergy Drugs from U.S. Market

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On Wednesday of this week, the FDA announced its intent to remove approximately 500 unapproved prescription medicines from the U.S. market. The unapproved drugs are all intended for the relief of allergy, cough, and cold symptoms. The FDA alleges that none of these drug products have gone through an agency review of their safety and effectiveness.

Because these drug products have never undergone review for safety and effectiveness, the FDA believes that the products pose a risk to consumers. According to the FDA, because there are so many FDA-compliant over-the-counter (OTC) and approved prescription drug products available to consumers to treat cough, cold, and allergy symptoms, the unapproved drug products for these conditions are not necessary for the treatment of the public.

This ordered removal of cold medications is the latest wave of enforcement action by the FDA in the agencys attempt to remove unapproved drug products from the market. A large number of the targeted, unapproved drugs have been marketed in the U.S. since before the 1962 federal law requiring drugs to undergo federal review for safety and effectiveness.

FDA officials cited specific concerns regarding risky combinations of ingredients in the unapproved products as well as “time-released” products that may release active ingredients too slowly, too quickly, or inconsistently. Furthermore, the FDA has indicated that some of these unapproved products bear names that are similar to other products which could result in medication mix-ups or errors.

The manufacturers of the drugs ordered to be removed from the market have been given 90 days to stop manufacturing and 180 days to stop distribution of the drugs.

The FDAs list of unapproved drugs marketed in the United States can be found here.

President Obama Warns FDA That Overhaul and Modernization Are Necessary

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Last week, the Financial Times reported that President Obama has warned the U.S. Food and Drug Administration (FDA) that it will be the target of a major overhaul due to its failure to keep up with advances in medicine and biotechnology. The President specifically mentioned the FDAs process for reviewing medical devices, implying that the process is outdated and in dire need of modernization. (We have previously discussed the controversy surrounding the FDAs medical device review process here and here.)

President Obama made these comments at a panel discussing jobs and the competiveness of the U.S. market. The President stated that his administration will try to make the U.S. economy more competitive by eliminating unnecessary regulatory burdens. During the panel, President Obama emphasized the importance of maintaining regulations necessary for the safety of the public but the need to eliminate regulations that create burdensome, unnecessary hurdles for advances and business.

For the FY 2012 budget, the President has proposed an increase of 33% of the FDAs budget to $4.3 billion. The Presidents complete budget for all of Health and Human Services (HHS), including FDA, can be viewed here.

With the recently passed Food Safety Modernization Act and the FDAs new Medical Device Innovation Initiative, in conjunction with the Presidents demand for the Agencys overhaul, a 33% increase of the FDA budget might not be enough. The FDA is not known for its quick action or adaptability so only time will tell whether these programs will bring about a modernized FDA.

New Food Safety Law Contains Protections for Whistleblowers

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Food industry workers turned whistleblowers have been faced with retaliation from their employers. However, thanks to a new provision in the sweeping food safety law signed by President Barack Obama last month, workers have gained protection. President Obama signed the FDA Food Safety Modernization Act (FSMA) on January 4th, 2011. The FSMA imposes safety standards and allows the U.S. Food and Drug Administration (FDA) greater authority to regulate tainted food (see our previous blog here).

Included in the FSMA is a provision (Section 402) to ensure that food industry employees will not face retaliation for any participation in proceedings concerning violations of the Food, Drug, and Cosmetic Act (FD&C Act). This provision serves to encourage employees to come forward, as they may now disclose food safety concerns without the fear of being terminated for speaking out on what they believe are safety violations. The provision provides that “[n]o entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise [. . .]” alter the terms and conditions of employment as a result of the employees participation in providing information concerning a violation of the FD&C Act. This provision provides whistleblowers protection from various types of employment-related consequences that may otherwise result from disclosing violations. While the provision protects employees from retaliation after disclosing information directly to the FDA, it also extends to disclosures voiced to employers, as well as an employees refusal to perform any activity reasonably believed to be in violation of the FD&C Act. If an employee is terminated or otherwise discriminated against in violation of this section, various forms of injunctive and compensatory relief are available to make the aggrieved party whole. The types of relief that may be granted include reinstatement, back pay and other special compensation, such as attorneys fees and other costs associated with litigation.

Because the FDA is unable to catch all food violations, whistleblowers are a critical resource to help warn the public of potential health hazards related to food. The new protections are designed to provide workers a greater sense of security in reporting problems to managers without fear of being fired, demoted or being subjected to other adverse employment actions. Ideally, the protections will allow companies to become aware of and provide quicker responses to potential issues before the problems can escalate to wide-spread public health concerns.

For more information on the FDA Food Safety Modernization Act and the Whistleblower protections, please contact us at contact@fidjlaw.com.

FDA Food Safety Modernization Act Adds Requirements for Grocery Stores

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In addition to the key elements we have previously reported, the FDA Food Safety Modernization Act of 2010 adds new requirements for grocery stores. In Section 417 of the Federal Food, Drug, and Cosmetic Act, the FDA will now have to prepare a standardized one-page summary of critical information for a reportable food and publish it on the FDAs website in a format that can be easily printed by a grocery store for consumer notification. A reportable food is any article of food, other than infant formula, where there is a reasonable probability that the use of, or exposure to, such food will cause a serious adverse health consequence or death. 21 U.S.C. § 350f(a)(2).

Grocery stores that are part of a chain of establishments with fifteen (15) or more physical locations that sold a reportable food, shall prominently display the one page summary of information no later than 24 hours after it was published by the FDA. The grocery store shall display the summary for fourteen (14) days. No later than one year from the date of enactment of the FDA Food Safety Modernization Act, the FDA must develop and publish a list of acceptable conspicuous locations, which grocery stores will use for providing consumer notification. The list must include the following items:

  • posting the notification at or near the register;
  • providing the location of the reportable food;
  • providing targeted recall information given to customers upon purchase of a food; and
  • other such prominent and conspicuous locations and manners utilized by grocery stores as of the date of the enactment of the FDA Food Safety Modernization Act to provide notice of such recalls to consumers as considered appropriate by the Secretary.

21 U.S.C. § 350f(h)(2). We will continue to monitor the FDA for promulgation of the list and manners to which grocery stores must use to provide consumer notification.

For more information on the FDA Food Safety Modernization Act, please contact us at contact@fidjlaw.com.

E-Cigarette Distributor Sues to Stop FDA from Preventing the Importation of Electronic Cigarettes

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In an ongoing saga of litigation between electronic cigarette (“E-Cigarette”) distributors and the FDA regarding the power of the FDA to regulate and prevent the importation of E-Cigarettes, another E-Cigarette distributor has thrown its hat into the ring. Last week, Totally Wicked “E.Liquid (“TWI”) filed suit in the United States District Court in Washington DC to prevent the FDA from regulating TWIs electronic cigarettes as a drug, medical device, or combination of the two and from barring their importation. A copy of that lawsuit can be seen here. TWI claims that their product is a tobacco product and should be regulated as such and not as a drug, medical device or combination thereof.

On December 7, 2010, in the case of NJOY v. FDA, the United States Court of Appeals for the D.C. Circuit affirmed a District Court decision in the e-cigarette industrys favor which enjoined the FDA from regulating e-cigarettes as drugs. That opinion can be seen here. However, it appears that the FDA is nevertheless continuing to regulate of E-Cigarettes despite the DC Circuits ruling, and has issued additional import alerts regarding E-Cigarettes. As such, TWI has now filed suit to protect its own interests and to have the D.C. Circuits opinion applied to its own products.

Fuerst Ittleman lawyers are experienced in bringing suit against regulatory agencies such as the FDA when they seek to regulate products outside their jurisdiction or in ways not in conformity with their own regulations.