On June 25, 2013, the FDA announced that for the first time since the passage of the Family Smoking Prevention and Tobacco Control Act, which granted the agency the authority to regulate cigarettes and other tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway. A copy of the FDA’s press release can be read here.

While the FDA does not “approve” tobacco products as it would drugs, it does regulate which products may be marketed through the Tobacco Control Act. If FDA determines a new tobacco product meets the relevant legal requirements, FDA will issue a written notification permitting the marketing of the new tobacco product. Under the Tobacco Control Act, tobacco manufacturers may use one of three pathways when seeking to market “new tobacco products.” [A “new tobacco product” is a product that was not sold in the United States prior to February 15, 2007. Also any modification made to tobacco products which were in existence as of February 15, 2007 reclassifies the product as a “new tobacco product.”] These pathways are: 1) premarket review and approval; 2) substantial equivalence; or 3) exemption from substantial equivalence regulation. An overview of these pathways can be read on the FDA’s website here.

Generally speaking, pursuant to section 910 of the Food, Drug, and Cosmetic Act, prior to marketing a new tobacco product a manufacturer must submit a premarket tobacco product application and receive an order authorizing marketing from the FDA. The FDA’s traditional “safe and effective” standard for evaluating drugs does not apply to tobacco. Rather, premarket approval requires the applicant to demonstrate that the FDA permitting the marketing of the new tobacco product would be “appropriate for the protection of the public health.” The statute provides that the basis for this finding shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account: 1) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and 2) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

Premarket approval is required unless pursuant to section 905(j), 1) the manufacturer submits a report (known as a “905(j)” report) and is granted an order finding that its product is substantially equivalent to a tobacco product marketed in the U.S. prior to February 15, 2007; or 2) the tobacco product is exempt from the requirements of section 905(j) pursuant to a regulation issued under 905(j)(3). A new tobacco product is “substantially equivalent” to a predict tobacco product if the FDA has found that the new product:

• Has the same characteristics as the predicate product; (“characteristics” means the materials, ingredients, design, composition, heating source, or other features of a tobacco product), or
• Has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under section 910 because the product does not raise different questions of public health.

It should be noted that a new tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated. The FDA has published additional guidance on 905(j) reports which can be read here. While similar to the scheme established for approval of medical devices there are some slight differences. The most glaring difference between tobacco product and medical device substantial equivalence determinations is that tobacco products may only rely on one predicate product whereas a medical device is free to use more than one predicate device to establish substantial equivalence.

The final pathway to marketing tobacco products is through the granting of an exemption from substantial equivalence by the FDA. Pursuant to 21 C.F.R. § 1107.1, the FDA may exempt  products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive if: 1) such modification would be a minor modification of a legally marketed tobacco product; 2) a 905(j) report is not necessary to ensure that permitting marketing would be appropriate for the protection of the public health; and 3) an exemption is otherwise appropriate.

While the FDA now plays an increased role in the regulation of tobacco products, 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 Protection Litigation (OCPL) 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.

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 David & Joseph PL at contact@fidjlaw.com.

On June 2, 2013, U.S. Food and Drug Administration (“FDA”) Commissioner Margaret Hamburg delivered a speech at the American Society of Clinical Oncology’s annual meeting, in which she explained that the FDA is in the process of changing the regulations governing laboratory-developed tests (“LDTs”). (To read the full text of Commissioner Hamburg’s speech, please click here.) In her speech, Commissioner Hamburg stated that the FDA is developing a risk-based framework that is intended to “make sure that the accuracy and clinical validity of high-risk tests are established before they come to the market” and “provide for safe and effective diagnostics while promoting innovation and patient access.” Although the FDA has not formally announced any changes to the regulation of LDTs, Commissioner Hamburg’s comments suggest that the FDA is closer to finalizing the modified regulatory framework for LDTs. (To read our previous coverage of the FDA’s regulation of LDTs, please click here.)

Background 

The FDA defines LDTs as “a class of in vitro diagnostics that are manufactured, including being developed and validated, and offered, within a single laboratory.” (To read the full text of the Federal Register notice requesting comments for the Oversight of Laboratory Developed Tests published on June 17, 2010, please click here.) Common examples of LDTs are genetic tests, emerging diagnostic tests, and tests for rare conditions. The FDA claims authority to regulate LDTs under the federal Food, Drug, and Cosmetics Act but has not drafted applicable regulations with respect to LDTs. Therefore, the primary federal regulation of laboratories and LDTs has been under the Clinical Laboratory Amendments of 1988 (“CLIA”).

Since 1992, the FDA has consistently maintained its position that it will not enforce regulations regarding LDTs. The most notable departure came on June 10, 2010, when the FDA issued five Untitled Letters to companies stating that their tests did not qualify as LDTs because they were “not developed by and used in a single laboratory.” (To read the FDA’s Untitled Letters to Industry, please click here, here, here, here, and here.) In those instances, the FDA determined that it would regulate those tests as medical devices and require premarket approval. In June 2010, the FDA stated that increased regulation of LDTs may be necessary due to the changing nature of LDTs from “generally relatively simple, well-understood pathology tests” to tests that “are often used to assess high-risk but relatively common diseases and conditions and to inform critical treatment decisions.” (To read the full text of the Federal Register notice regarding federal oversight of LDTs, please click here.)

One week after the FDA issued the Untitled Letters described above, the FDA announced that it would hold a public meeting because the “agency believe[d] it [was] time to reconsider its policy of enforcement discretion over LDTs.” (To read the full text of the Federal Register notice requesting comments for the Oversight of Laboratory Developed Tests published on June 17, 2010, please click here.) In the Federal Register notice announcing that public meeting, the FDA stated that LDTs were originally intended to be used by doctors and pathologists within a single facility or institution where both the doctor and pathologist were actively involved in the patient’s care. According to the FDA, the nature of LDTs had changed significantly over the last two decades. The FDA indicated in the Federal Register notice that modern LDTs are often used to diagnose “high-risk” diseases and conditions and to guide “critical treatment decisions.” Furthermore, the FDA explained that modern LDTs have departed from traditional LDTs because modern tests are “often performed in geographically distant commercial laboratories instead of within the patient’s health care setting under the supervision of the patient’s pathologist and treating physician.”

On July 19-20, 2010, the FDA held the public meeting to discuss the state of regulations governing LDTs. In that meeting, the FDA reiterated that laws for regulating LDTs were already in effect and that the agency had merely exercised enforcement discretion with respect to LDTs. The FDA also claimed that it could implement a new regulatory framework at any time through the issuance of guidance. With the exception of the FDA’s issuance of Untitled Letters in June 2010, the FDA has not taken any formal steps to exercise its enforcement authority. (For more information about the FDA’s public meeting, please click here.)

Roughly two years after the FDA’s public meeting, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”), which requires the FDA to notify Congress at least 60 days prior to issuing a draft or final guidance on the regulation of LDTs. (For the full text of FDASIA, please click here.) The legislative history is silent as to Congress’s rationale for requiring the FDA to provide notice prior to issuing new guidance; however, some have interpreted this provision to suggest that Congress views LDTs as an important issue that warrants close monitoring. At a minimum, the notification requirement contained in FDASIA effectively acts as a warning to industry to prepare for new changes to the regulation of LDTs before they take effect.

Resistance to FDA’s Regulation of LDTs

The FDA’s push for increased regulation over LDTs has been met with resistance by the laboratory industry. On June 6, 2013, the American Clinical Laboratory Association (“ACLA”) submitted a Citizen Petition requesting the FDA to confirm that LDTs are not devices under the FDCA. (For more information about ACLA’s Citizen Petition, please click here. To read the full text of ACLA’s Citizen Petition, click here.) In its Citizen Petition, the ACLA argued that the Center for Medicare and Medicaid Services (“CMS”) has authority to regulate LDTs under the CLIA and, therefore, LDTs are beyond FDA’s jurisdiction. This Citizen Petition is not the first of its kind to suggest that the FDA does not have authority to regulate LDTs. In fact, the FDA has addressed and denied similar Citizen Petitions in the past.  (For example, Genentech submitted a Citizen Petition regarding LDTs in 2008, which is available here.)

Moving Forward

Commissioner Hamburg’s speech at the American Society of Clinical Oncology meeting is the most recent public FDA activity in the area of LDT regulation since it issued Untitled Letters to industry in 2010. However, it is important to recognize that the FDA could move forward at any time and issue new guidance modifying how LDTs are regulated. Members of the laboratory industry should be prepared to comment on any proposed guidance or regulation that the FDA may announce in the Federal Register. Additionally, it would be prudent for physicians and laboratories  using or creating such tests to take notice of whether their tests satisfy the criteria for LDTs or whether the tests could otherwise qualify for regulation as medical devices.

Fuerst Ittleman David & Joseph, PL will continue to monitor any developments in the regulation of LDTs. For more information, please contact us via email at contact@fidjlaw.com or via phone at (305) 350-5690.

Laboratory-developed tests (“LDTs”) appear to be under FDA’s microscope once again. These tests, which include genetic tests, companion diagnostics, and genetic tests, are developed and performed by a laboratory and have been the source of years of strife between the laboratory industry and FDA. FDA has historically stated that it exercises enforcement discretion when it comes to LDTs. However, on June 2, Margaret Hamburg, commissioner of FDA, stated during an American Society of Clinical Oncology meeting that FDA is considering taking some sort of action with regard to its regulation of LDTs. That sentiment reflects FDA’s position from a June 17, 2010 Federal Register notice stating that more regulation of LDTs may be necessary due to FDA’s observations that the nature of LDTs was changing from “generally relatively simple, well-understood pathology tests” to tests that “are often used to assess high-risk but relatively common diseases and conditions and to inform critical treatment decisions and are often performed in geographically distant commercial laboratories instead of within the patient’s health care setting under the supervision of a patient’s pathologist and treating physician, or may be marketed directly to consumers.” A copy of that Federal Register notice is available here.

To complicate matters, the Food and Drug Administration Safety and Innovation Act (“FDASIA”), enacted last year, requires that FDA notify Congress with the details of any anticipated action at least 60 days before issuing any draft or final guidance on the regulation of LDTs. Not surprisingly, the laboratory industry strenuously opposes FDA regulation. As evidenced by a Citizen Petition submitted by the American Clinical Laboratory Association (“ACLA”) to FDA requesting that FDA confirm that LDTs are not devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”), ACLA argues that LDTs are beyond FDA’s jurisdiction because the Center for Medicare and Medicaid Services has authority to regulate LDTs under the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”). FDA has addressed and denied such Citizen Petitions in the past.

As FDA may move forward with regulating LDTs as medical devices, members of the laboratory industry should be aware of the potential controversial change in FDA policy and should be prepared to comment on any proposed guidance or regulation that the agency may produce on LDT policy or regulation. Additionally, physicians and laboratories developing and using LDTs should be aware of whether their tests meet the recognized criteria of LDTs or whether their tests could qualify as medical devices subject to FDA regulation.

Fuerst, Ittleman, David & Joseph, PL will continue to track and report on FDA’s position related to laboratory developed tests. For more information, please contact us via e-mail at contact@fidjlaw.com or via telephone at (305) 350-5690.

As we recently reported, federal regulators have continued to take measures aimed at stymieing the growth of the marijuana industry. Medical marijuana is now legal in over 18 states and, in November 2012, voters in Colorado and Washington legalized the sale of recreational marijuana to adults age 21 or older. However, possessing, cultivating, and distributing marijuana remains illegal under federal law, despite state laws to the contrary, and the federal government has aggressively pursued medical marijuana dispensaries for violating federal laws. (For more information about the federal government’s crackdown on medical marijuana dispensaries, please read our previous posts  here, here, and here.). As Colorado and Washington’s marijuana laws go into effect, the federal government is faced with new questions regarding the manufacture and sale of “medibles,” food and beverages infused with marijuana. Of particular concern for medibles manufacturers is how, if at all, edible marijuana products implicate regulation by the U.S. Food and Drug Administration (“FDA”). (For more coverage regarding edible marijuana products, please read NBC’s article here.)

The FDA, the federal agency primarily responsible for the safety of the nation’s food supply, has specific regulations regarding the manufacture, quality, and labeling of food products. Under 21 U.S.C. § 321(f) of the federal Food, Drug, and Cosmetics Act (“FDCA”), a “food” is loosely defined as “an article used for food or drink.” Products that are intended to be consumed as foods or are otherwise labeled or represented as food products must comport with the FDA’s regulations. Pursuant to the FDA’s regulations, food manufacturers must register their establishments with the FDA and operate in accordance with current good manufacturing practices (“cGMPs”). (Generally speaking, cGMPs are a series of regulations, found at 21 C.F.R. Part 110, designed to ensure that food products are prepared, packaged, and stored in sanitary conditions.).

In addition, food manufacturers must also ensure that food products do not contain any unapproved substances or additives and that the ingredients contained in food products are generally recognized as safe (“GRAS”). As described by the FDA:

GRAS is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

More information on GRAS requirements can be found on the FDA’s website here.

Moreover, food products must bear correct food labeling, including a Nutrition Facts panel and appropriate food claims. Manufacturers that fail to meet cGMPs or use ingredients that are not GRAS in their food products could be subject to enforcement action under the misbranding or adulterated food provisions of the FDCA.

With marijuana legalization, commercial retailers in Colorado and Washington have started developing various “medible” products. However, as of now these manufacturers have been operating in a void of regulations because marijuana remains illegal under federal law. As a result, FDA has not developed GRAS regulations for marijuana and has not publicly commented on the applicability of cGMPs to medible manufacturers.

Although the FDA has not released an official position on whether or how it intends to regulate medible products, medibles likely could trigger heightened FDA scrutiny. An initial question which must be evaluated by the FDA is whether medibles qualify as foods at all, or whether their intended uses would qualify these products as drugs under the FDCA. (21 U.S.C. § 321(g) defines the term “drug” in part to mean “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”).

If the FDA deems medibles to be foods, medibles would then be required to be manufactured using good manufacturing practices and product labeling compliant with FDCA regulation of foods. However, even if cGMPs and labeling requirements are satisfied, manufacturers, distributors, and sellers of marijuana medibles could still face liability under the FDCA because the FDA has not approved marijuana as a food ingredient or food additive and has not deemed marijuana to be GRAS. Generally speaking, products which contain food additives and ingredients that are not GRAS are considered adulterated under the FDCA. Thus, if the FDA were to assert jurisdiction and begin regulating medibles as foods, under the current regulatory regime FDA would likely allege that medibles are adulterated.

Manufacturers and distributors of marijuana medibles face the possibility of several FDCA violations should marijuana medibles be considered adulterated food products. These include: 1) the adulteration of a food product in interstate commerce; 2) introduction or delivery for introduction into interstate commerce of an adulterated food product; and 3) the receipt in interstate commerce of any food that is adulterated, and the delivery or proffered delivery thereof for pay or otherwise. See 21 U.S.C. § 331 (a), (c). The penalties and punishments associated with these crimes are governed by 21 U.S.C. § 333 and depend on whether the government charges the defendant with committing a violation “with the intent to defraud or mislead.” Each of these penalties is available regardless of whether marijuana is legal under State law.

Regardless of how FDA regulates medibles, the federal government has made clear that marijuana is still classified as a Schedule I drug under the Controlled Substances Act (“CSA”). Accordingly, distributors face the risk of additional criminal penalties beyond those prescribed within the FDCA.  21 U.S.C. § 841 prohibits the manufacture and distribution of a controlled substance expect as permitted under the CSA. Unlike the FDCA where first offenders convicted of adulteration violations face a maximum of three years imprisonment, first time offenders under the CSA face a minimum of five with a possibility of a maximum of forty years imprisonment. Because the production of medibles is not permitted under the CSA, criminal indictments under this separate regulatory regime are still possible.  Such indictments would be similar to those of three medicinal marijuana dispensary operators late in 2012. (More information on those indictments can be read in our previous report here.).

Due to the federal government’s apparently unwavering position on marijuana products, some Congressional lawmakers have introduced legislation that restricts federal involvement in regulating the sale and use of marijuana. On March 7, 2013, Representative Dana Rohrabacher proposed a new bill to Congress entitled the “Respect State Marijuana Laws Act of 2013” (H.R. 1523). The proposed bill protects both marijuana businesses and individual marijuana users from federal or criminal prosecution so long as their acts comply with existing state laws. Specifically, the Respect State Marijuana Laws Act of 2013 proposes to add the following language to the Controlled Substances Act (21 USC 801 et seq.): “Notwithstanding any other provision of law, the provisions of this subchapter related to marihuana shall not apply to any person acting in compliance with State laws relating to the production, possession, distribution, dispensation, administration, or delivery of marihuana.” Congress has yet to vote on this bill.

Unless and until the federal government begins to respect state laws governing marijuana, marijuana growers and commercial manufacturers should be aware of the potential issues that will continually arise due to the conflict between state and federal law.

The attorneys at Fuerst Ittleman David & Joseph, PL have extensive experience in the areas of administrative law, constitutional law, regulatory compliance, white collar criminal defense and litigating against the U.S. Department of Justice. You can reach an attorney by emailing us at contact@fidjlaw.com or by calling us at 305.350.5690.

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them. In today’s Federal Register, which you can read here, FDA made those intentions official when it released its Proposed Order entitled “General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth to be Known as Sunlamp Products.” The interested public, including the regulated industry, may submit written comments to the FDA regarding this Proposed Order on or before August 7, 2013.