FDA Food Safety Modernization Act Adds Requirements for Grocery Stores

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

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.

New Bill Seeks to Limit the Way Manufacturers Handle Recalls

Last week, United States Senator Charles Schumer (D-NY) introduced a bill aimed at limiting the options that manufacturers may pursue in the event of a product recall.  Found here, the Consumer Recall Protection Act states that “. . . a person may not sell to a consumer any covered product that is subject to a recall.”  As written, the Act will apply to a variety of products, including food, drugs, cosmetics and devices, all covered by the Food, Drug, and Cosmetic Act (FD&C).  If enacted, the Consumer Recall Protection Act will prohibit manufacturers from selling recalled products to consumers until the defect prompting the recall is remedied. 

The Bill may have come as a response to the recent controversies raised by Johnson & Johnson’s “phantom recall” efforts.  As previously reported, the handling of several recalls by J&J has led to scrutiny of the current recall process by the FDA and Congress.  After years of concern regarding the company’s manufacturing and responsiveness to FDA warnings, the massive recall of Children’s Tylenol in 2010 led Congress to probe the effectiveness of the FDA’s regulation of drug manufacturing.  During a recent hearing before the House, the FDA expressed its concern regarding J+J and the company’s efforts to postpone recalling its products.  In what is known as a “phantom recall,” J+J hired contractors to go into stores and purchase its products rather than conducting a widespread and highly-public voluntary recall.   

In addition to combating the “phantom recall,” recent legislative efforts have focused on reforming the current voluntary recall process for drug products.  Because the current drug recall scheme is voluntary, the FDA is often able to prompt manufacturers into initiating recalls after alerting the public of the possible dangers associated with the products at issue.  While the recent Food Safety Modernization Act, discussed here, granted authority to the FDA to issue mandatory recalls in certain circumstances, the FDA does not currently have the power to initiate recalls of drugs.  However, the voluntary recall process for drug products may soon come to an end.  As recently reported, new legislation has been introduced in the House that focuses on reforming the FDA’s ability to oversee and enforce drug safety.  The bill, known as the Drug Safety Modernization Act, largely mirrors the recent food safety legislation and contains provisions giving the FDA mandatory recall authority over drug products.  

While it appears that Congress is scrambling to restore public confidence in the FDA’s ability to keep consumers safe, the potential effectiveness of the newly proposed Consumer Recall Protection Act is questionable.  Although the bill may largely be a response to J+J’s phantom recall efforts, the Act will only prevent companies from selling products to consumers once a recall has already been initiated.  Because the Act would only apply once a recall has been initiated, it would not have prevented the phantom recall situation that J+J engaged in.

FDA to Unveil Rules for Reviewing Biosimilars “Very Soon”

The U.S. Food and Drug Administration (FDA) will announce new rules for reviewing the first copies of biologic drugs, also known as “biosimilars.” According to FDA Commissioner Margaret Hamburg, these new rules will be formally implemented in “the very near-term time frame.”

The health-care overhaul passed last year included a provision that authorized the FDA to develop a process for approving cheaper copies of compounds made from living cells. The FDA is currently evaluating different models for evaluating that the biosimilars work as well as the products they copy.

In the absence of final rules, generic companies have been filing the same biologics license applications (“BLAs”) used for brand-name drugs. The BLA process does not create savings for patients like the generic drug program for traditional medicines. According to the Congressional Budget Office, it is estimated that Americans would save $25 billion in a decade through rules allowing copies of biologic drugs.

Hamburg stated that the FDA plans to discuss with industry in the next couple of months how much it will charge to review applications for biosimilar products under the new rules. This is a step in the right direction for moving forward with rules for reviewing biosimilars. Fuerst Ittleman will monitor FDAs progress with developing final rules.

For more information on biosimilar products, please contact us at contact@fidjlaw.com.

NOAA Seeks to Expand Aquaculture to Increase Consumption of Domestic Seafood

The National Oceanic and Atmospheric Administration (NOAA) recently released a draft policy document detailing its intentions to increase aquaculture domestically. The cultivation of sea-life in selected environments, a process known as aquaculture, is a priority for the NOAA because of the current disparity between domestic and overseas seafood production. According to the draft policy, “[a]pproximately 84 percent of the seafood consumed in the United States is imported, about half of which is sourced from aquaculture.” Further, while half of seafood consumed in the U.S. comes from aquaculture, only about 5 percent comes from domestic sources. While the NOAA is seeking to increase the growth of aquaculture domestically, these efforts are being touted as a means to reduce the trade deficit. With approximately $9 billion worth of seafood being imported into the United States each year, seafood is one of the largest contributors to the deficit.

For more information about the policies or regulations affecting trade, please contact us at contact@fidjlaw.com.

Medical Device Manufacturers Seek Quick Approval Overseas

Recently, medical device manufacturers have been shifting their operations overseas in an effort to speed up the approval process. More relaxed regulatory oversight abroad has led some of these companies to make the move to Europe, Asia, and Latin America. Rather than deal with the stringent approval process for medical devices in the United States, these companies are looking for a less costly and time consuming way to bring new products to market.

While the FDA is responsible for administering the regulatory scheme surrounding medical devices in the United States, critics argue that the Agency has gone too far by scrutinizing new products and creating a lengthy, complex process. Currently, the two main pathways for medical devices to enter the market are through premarket approval (PMA) and the 510(k) process. While the premarket approval process is a more complicated and time-consuming pathway, both require a device manufacturer to demonstrate that the product is safe and effective for its intended use. The advantage that device manufacturers may find abroad is a more relaxed approval process through which a demonstration of a devices safety alone may secure the approval necessary to bring a product to market. Unlike the regulatory requirements in the United States, showing that a device is effective for its intended use is often not required abroad.

However, this perceived advantage may be short-lived. The FDA has begun to review the current pathways for medical devices. As we previously reported, the FDA recently proposed several changes to the 510(k) process. These changes are primarily aimed as increasing the efficiency of the device approval process and reflect some recognition that reform is necessary to ensure that the United States remains at the forefront of medical device innovation. As we previously reported, the FDA has also proposed its Innovation Initiative, a plan targeted at streamlining the medical device approval process thereby reducing costs associated with research and development of new devices. While no official changes to either the PMA or 510(k) process have come into effect, the FDA expects to implement some of these measures later this year.

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.

FDA Announces Availability of “Medical Device Innovation Initiative” Report for Public Comment

The U.S. Food and Drug Administrations (FDA) announced in the Federal Register on February 9, 2011 that its report entitled “Medical Device Innovation Initiative” is available for public comment. This report proposes potential actions to be taken by the FDAs Center for Devices and Radiological Health (CDRH) to facility the development, assessment, and regulator review of innovative medical devices.

On February 8, 2011, the FDA proposed its “Innovation Pathway,” which is a priority review program for “new, breakthrough medical devices.” The agency announced that the first submission to the program will be a “brain-controlled, upper-extremity prosthetic.” The FDA is seeking further public comment before the Pathway will be used more broadly.

CDRH announced 25 actions it will take this year to improve its 510(k) program, the FDAs premarket review process for certain medical devices. CDRH has expressed its desire to “increase its use of emerging science to foster innovation and improve the predictability, consistency, and transparency of its decision making.” Click here to read the FDAs “510K) and Science Report Recommendations: Summary and Overview of Comments and Next Steps.”

The report on medical device innovation outlines CDRH actions that may be put into place to accelerate the agencys evaluation of innovative devices. Some of these actions include:

  • Facilitate the development and regulatory evaluation of innovative medical devices;
  • Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
  • Prepare for and respond to transformative innovative technologies and scientific breakthroughs.

The Federal Register notice announcing the availability of the report for public comment acknowledges that the U.S is the global leader in innovative medical devices. The notice states that millions of Americans benefit from innovative medical devices that “reduce suffering, treat previously untreatable conditions, extend lives, and improve public health.” CDRH has stated that because of the need for these innovative devices, the office has committed itself to assuring that these new technologies and products are available on a timely basis while still retaining their safety and efficacy.

The FDA has been criticized by the medical device industry for its 510(k) process. The industry has been vocal in its views that the review process is much too slow and much too inconsistent. Click here to read an article in the New York Times on domestic medical device firms sending business overseas.

CDRH is seeking public comment on the report and the proposals outlined therein. The FDA will be holding a public meeting to garner stakeholder feedback at its White Oak, Maryland campus on March 15, 2011.

The FDA news release on its Innovation Initiative can be found here.

FDA Releases Criteria For Criminal Prosecution Under Park Doctrine

The FDA has released “criteria” it developed for consideration of which cases would be appropriate for misdemeanor criminal prosecution under the Park Doctrine, named after a Supreme Court case called United States v. Park, 421 U.S. 658 (1975).

Under the Park Doctrine, an executive may be criminally prosecuted for violations of the Food, Drug & Cosmetic Act, if he or she had, by reason of his or her position in the corporation, responsibility and authority either to prevent in the first instance, or to promptly correct the violation of the law. This is known as the “responsible corporate officer doctrine,” which does not require that the corporate officer be aware of wrongdoing within the company. Use of this doctrine is limited to misdemeanor offenses involving regulatory or public safety crimes that do not have an intent requirement.

The new criteria released by the FDA is not binding on the agency, and creates no rights or benefits on the behalf of a putative defendant who is potentially subject to Park responsible corporate officer liability. In addition to the individuals position in the company and whether he or she had the authority to prevent or correct the violation, the FDA will also consider, when determining whether to bring a Park Doctrine indictment:

  1. Whether the violation involves actual or potential harm to the public;
  2. Whether the violation is obvious;
  3. Whether the violation reflects a pattern of illegal behavior and/or failure to heed warnings;
  4. Whether the violation is widespread;
  5. Whether the violation is serious;
  6. The quality of the legal and factual support for the proposed prosecution; and
  7. Whether the proposed prosecution is a prudent use of agency resources.

The announcement regarding the new criteria may be found here.

The FDA has expressly stated that it will seek to increase the amount of Park Doctrine criminal prosecutions of corporate executives whose companies are involved in Food, Drug & Cosmetic Act violations. This increase in enforcement is part of the FDAs aggressive stance in a variety of investigations, one of which has recently resulted in the prosecution of a companys lawyer for obstruction of justice, as we previously blogged here. Compliance reviews, and if necessary, a strong defense team in the face of such potential jeopardy to ones liberty is advisable, necessary and prudent in todays regulatory environment. In addition, when facing a potential Park Doctrine prosecution, executives should consider obtaining separate counsel from their employers, free of any potential conflicts of interest with the company.

Fuerst Ittleman attorneys have represented clients in a variety of FDA-related criminal investigations and prosecutions. For more information, please contact us at contact@fidjlaw.com.

Seizures of Counterfeit Goods a Priority for CBP

Reaffirming its commitment to keeping counterfeit merchandise from reaching consumers, U.S. Customs and Border Protection (CBP) has been busy in recent months. Recently, CBP announced that its officers at the Detroit Metropolitan Airport seized 192 separate shipments of fake merchandise between November 1, 2010 and January 17, 2011. During this period, the seizures included counterfeit designer purses, sunglasses, cell phones, and sports jerseys. According to CBP estimates, the seized items totaled an estimated worth of $2 million.

Additionally, CBP announced that its inspectors at the Los Angeles/Long Beach seaport complex were able to seize a shipment of counterfeit Marlboro cigarettes. The shipment from China contained over 22,000 cartons of fake Marlboro cigarettes. In an effort to get the shipment through customs, the shippers of the merchandise provided false invoicing information, identifying the contents as “hang tags and hang plugs.” However, an examination of the shipment by CBP import specialists and inspectors revealed its true contents.

With countless seizures of illegal goods being made, CBP has signaled that stopping counterfeit goods is a main priority. According to CBP, the sale of counterfeit goods is problematic for a few key reasons. First, fraudulent goods may be dangerous to consumers, as the imposters often appear to be of the same quality but have the potential to be inferior and present added safety risks to unsuspecting consumers. Additionally, CBP notes that counterfeit products negatively affect trademark owners who have invested time and money developing their products. Lastly, criminal organizations are often involved in the sale of counterfeit merchandise to launder the organizations illegal profits.

With the amount of counterfeit goods being attempting make entry into the U.S. is unlikely to slow, CBP is expected to have a busy year ahead.

Lawyers at Fuerst Ittleman PL are experienced in handling issues and litigation regarding products that are either counterfeit or otherwise infringe on legal trademarks.

Fourth Circuit Dismisses Challenge To Federal Embryonic Stem Cell Research Funding Citing Lack Of Standing Of Challengers

On January 21, 2011, the United States Court of Appeals for the Fourth Circuit affirmed a decision of the District Court of Maryland dismissing a consolidated case challenging the federal funding of research involving embryonic stem cells. In agreeing with the District Court, the Fourth Circuit found that both plaintiffs lacked standing, an essential constitutional requirement to bringing case before the court. A copy of the decision can be read in full at: Mary Scott Doe v. Obama.

Article III of the United States Constitution provides that the judicial power of the federal court system extends to “cases” and “controversies.” However, in order to bring a case, the plaintiff must have “standing” to assert its claim. To satisfy the constitutional requirement of “standing,” a plaintiff must establish: 1) it has suffered an “injury in fact” which is “concrete and particularized” and “actual or imminent” and not merely “hypothetical;” 2) causation, i.e. the injury is “fairly traceable to the challenged action of the defendant;” and 3) redressability, meaning that “it is likely, as opposed to merely speculative” that the injury will be remedied by a favorable decision. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180-81 (2000).

In Mary Scott Doe, two groups of plaintiffs attempted to challenge the constitutionality of Executive Order 13505 (“EO 13505”) and its implementing National Institute of Health (“NIH”) Guidelines which expanded federal funding of human embryonic stem cell research. NIH Guidelines currently permit funding for research involving stem cells from embryos “donated by individuals who sought reproductive treatment . . . and who gave voluntary written consent for the human embryos to be used for research purposes.” 74 Fed. Reg. 32170, 32174. The plaintiffs alleged that EO 13505 and the NIH Guidelines violated the 13th and 14th Amendments to the U.S. Constitution as well as the Administrative Procedure Act and the Dickey-Wicker Amendment, which prohibits use of federal funds for “research in which a human embryo . . . is destroyed, discarded, or knowingly subjected to risk of injury or death.”

The first named plaintiff, Mary Scott Doe, represented a class of all frozen embryos held throughout the US for either research or adoption purposes. The plaintiffs argued that the class of frozen embryos had standing because EO 13505 and the NIH Guidelines “increase the embryos risk of being reduced to . . . stem cells” thus creating an “injury in fact” necessary to bring a case. However, the Court rejected this argument, stating that in order to establish standing “named plaintiffs who represent a class must allege and show that they personally have been injured, not that injury has been suffered by other, unidentified members of the class to which they belong and which they purport to represent.” (emphasis added). The Court went on to state that because the “complaint provides no basis to conclude that the named plaintiff . . . [will] suffer any injury at all, much less an injury due to the challenge government policy,” “Doe” has failed to allege a “concrete and particularized harm.” Thus, the Court found that “Doe” could not establish an injury in fact.

Furthermore, the Court found that even if “Doe” could assert an injury, “Doe” could not establish causation on the part of the defendant, the US government. Here, the Court found that funding for research was limited to those embryos which were voluntarily donated for research by biological donors. As such, any injury which could have occurred was the result of the independent actions of a third party, not the named defendant. “Where a third party . . . makes the independent decision that causes an injury, that injury is not fairly traceable to the government . . . .The mere fact that the government permits private donors to chose to donate their embryos for research does not . . . make the decision fairly traceable to [EO] 13505 or the NIH Guidelines.”

The Fourth Circuit also affirmed the dismissal for lack of standing for the second group of plaintiffs, parents who have children that were adopted frozen embryos and who are considering adopting embryos again. The Court found that the adoptive parent plaintiffs did not claim that they had already suffered an injury. Rather, the adoptive parent plaintiffs claimed that they faced the treat of a future injury because “EO 13505 will reduce the number of in vitro human embryos available for adoption such that they will be unable to adopt.” However, the Court went on to find that the adoptive parent plaintiffs failed to allege facts to “infer that such injury would be actual or imminent.”

In finding that the adoptive parent plaintiffs lacked standing, the Fourth Circuit relied upon Supreme Court precedent established in Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992). In Lujan, the Supreme Court found that in order for a plaintiff to establish standing through the claiming of a future injury, it must be alleged that future injury is “certainly impending.” Id. at 565 n. 2 (emphasis in original). In this case, the Fourth Circuit found that “the plaintiff parents . . . did not allege that they have already tried and failed to adopt embryos, nor do they allege any concrete plans for future adoption, so the possibility that they will never suffer the alleged injury looms too large.”

Fuerst Ittleman has built a reputation not only in the field of complex litigation but also in the legal aspects of the cutting edge field of stem cell research. If you have any questions pertaining to new NIH guidelines or to contact a complex litigation attorney please contact Fuerst Ittleman PL at contact@fidjlaw.com. For more information on Fuerst Ittlemans experience in the legal aspects of stem cell therapies, age management medicine, food and drug law in general, and FDA regulatory and enforcement actions, please visit our Food, Drug and Cosmetic Law practice page.