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Law360 (April 8, 2021, 2:54 PM EDT )
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| Katie Insogna |
The pace appears to be increasing: 43 in January, 60 in February and 63 in March. Moreover, year over year, the FDA has been busier this year as compared to the same time period in 2020, during which only 97 letters were issued.
Perhaps unsurprisingly, a large percentage of warning letters concern adulterated, unapproved or misbranded products related to COVID-19, including purported treatments and preventative products.
The FDA has approved COVID-19-related products through the emergency use authorization process. As a result, there is a limited — and readily identifiable — universe of approved products, making unapproved products easy to spot.
The FDA has invited the general public to report companies that are marketing unauthorized treatments. Such reports can lead to regulatory consequences from the agency, but may also increase a company's negative public profile.
Meanwhile, tobacco, another FDA priority, has also received significant attention, and e-cigarette companies continue to be in the agency's crosshairs for selling unapproved products. As use of vaping products by teenagers continues to rise — along with public concern — companies should be cautious about marketing products that have not received explicit clearance from the FDA, or that do not otherwise satisfy an exception to FDA approval.
Below are some key takeaways from the FDA's warning letter activity in the first quarter of 2021.
Products Marketed as Coronavirus Treatment or Prevention
The FDA is closely monitoring websites and social media for companies advertising products that, without approval or authorization by the agency, claim to mitigate, prevent, treat, diagnose or cure COVID‐19. Companies should be exceptionally cautious about making claims related to the efficacy of a product in diagnosing or treating the coronavirus.
From Jan. 1 through March 31, 28 of the 166 letters, or nearly 17%, went to companies purporting to sell COVID-19 treatments, or products intended to prevent COVID-19. Of those, 12 letters — almost half — came from the agency's Center for Devices and Radiological Health, or CDRH.
Of the remaining letters dealing with COVID-19 treatments or products, eight came from the Center for Drug Evaluation and Research, or CDER, six came from the Center for Food Safety and Applied Nutrition, and two came from the Division of Human and Animal Food Operations.[1]
Beyond warning letters — to which, in the case of letters concerning COVID-19-related products, the FDA may request an expedited response within 48 hours — the agency is going a step further, and publicly and proactively advising consumers not to purchase or use certain products that have not been approved, cleared or authorized by the FDA, and are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis or cure of COVID-19.
Companies receiving warning letters are added to a published list on the FDA's website.[2] Companies can get off that list once they have taken appropriate corrective actions, and the FDA has confirmed such remediation.
Center for Devices and Radiological Health
During the first quarter of 2021, the CDRH sent 12 warning letters to companies related to products purportedly intended to diagnose, or assist with the diagnosis of, COVID-19. Two letters related to serology tests, while the majority — 10 — was directed to companies marketing thermal scanners or other products to measure human body temperature.[3]
The FDA deemed these products adulterated and misbranded, because they did not receive marketing approval, clearance or other authorization from the agency. The Food, Drug and Cosmetic Act, or FDCA, requires such approval or clearance for devices where they are intended for use in the diagnosis of disease or other conditions.
In this context, telethermographic systems are devices within the meaning of this regulation, because they are intended for a medical purpose, such as body temperature measurement, even if used in nonmedical environments.[4]
The FDA is particularly concerned with the use of telethermographic devices for the assessment of human body temperature — and in particular, the risks associated with false positive and false negative results. As the agency stated in a warning letter issued to Thermoteknix System Limited on March 4:
The FDA is particularly wary of such risks where telethermographic devices scan multiple individuals simultaneously.A person with an undetected elevated temperature who was subject to temperature assessment using a telethermographic device may, as a result, be less likely to adhere to infection prevention and control guidelines, such as social distancing and using personal protective equipment.[5]
Center for Drug Evaluation and Research
While the CDRH is tasked with monitoring devices, the CDER is keeping tabs on manufacturers and retailers of other products.
During the first quarter, the CDER issued warning letters to a variety of manufacturers for products such as essential oils, tinctures, tea concentrate, reusable hand wipes, mouth spray and CBD products that are purportedly intended to mitigate, prevent, treat, diagnose or cure COVID-19. According to the CDER, the cited oils, tinctures and teas violated a host of FDA regulations, including being unapproved,[6] misbranded[7] and illegally offered for sale.[8]
The CDER also targeted suppliers of FDA-approved medications, such as hydroxychloroquine and azithromycin, that misstated their approved indications and/or overstated their use in patients with COVID-19, even when such medications have not been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation or cure of COVID‐19.
The agency's regulations are intended to protect consumers, because unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Likewise, drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether.
The CDER issued a total of 36 letters between Jan. 1 and March 31. The FDA takes consumer protection very seriously, and products related to COVID-19 are an exceptional priority. Accordingly, companies should be wary of marketing any products as useful in treating or preventing COVID-19 or any related symptoms.
Beyond the letters discussed above for products specifically advertised for use in treatment or preventing of COVID-19, the CDER also focused on hand sanitizers that failed to meet potency expectations, as well as other current good manufacturing practice, or CGMP, violations by active pharmaceutical ingredient and final drug product manufacturers. The agency also cited clinical investigators for failing to rectify clinical trial and research problems identified during previous FDA inspections.
Consumer purchases of hand sanitizers have increased significantly since the declaration of the global pandemic. Further, in light of Centers for Disease Control and Prevention recommendations and heightened interest in protection against disease, the FDA has focused quality evaluations on hand sanitizer manufacturers.
As a result, the FDA is monitoring hand sanitizer potency levels, particularly for products manufactured abroad and transported into the U.S. for sale. Indeed, as reflected in many of the warning letters, the agency has been detaining batches at the border and conducting testing for overall quality and potency.
During the period in question, the FDA found that many of the hand sanitizers fell below the expected potency. As a result, the products were considered adulterated, because the subpotency demonstrated that quality assurance within the facilities where they were manufactured was not functioning in accordance with CGMP requirements.
Many of the recipients of the recent warning letters were cautioned and advised to retain a CGMP consultant to evaluate operations and to assist them in meeting CGMP requirements. Any company that wants to manufacture and sell hand sanitizers should be particularly cognizant of CGMP and potency standards.
Center for Tobacco
The FDA continues to prioritize protecting consumers from unauthorized tobacco products. In particular, e-cigarette use among children and teenagers is a growing concern, reinforcing the need for FDA to take proactive action.
In 2020, the 139 Center for Tobacco letters comprised 22% of all warning letters issued. In the first quarter of this year, 77 of the 166 letters, or 46%, related to tobacco products. The vast majority of products at issue were e-cigarette or e-liquid products, and violated the FDA's requirements for premarket approval before sale in the U.S.
For background, the FDA's jurisdiction for oversight of this area can be found in a variety of FDCA regulations. The agency regulates products made or derived from tobacco and intended for human consumption.[9]
FDA jurisdiction extends to and specifically includes e-liquids, which must comply with FDCA requirements.[10] The FDA's specific oversight of these products, including e-cigarettes and e-liquids, was extended effective Aug. 8, 2016, through a broader definition of a tobacco product.[11]
Generally, the FDCA requires new tobacco products — defined as any tobacco product that was not commercially marketed in the U.S. as of Feb. 15, 2007 — to have a premarket authorization order to be legally marketed in the U.S.[12] Excluded from the definition of new tobacco products are modified tobacco products that were commercially marketed after Feb. 15, 2007.[13]
A premarket authorization for a new tobacco product is required absent substantial equivalence to a predicate product, or satisfaction of an exemption to the substantial equivalence requirement.[14]
For a product to be deemed substantially equivalent — thus obviating the need for a premarket authorization order — the manufacturer must submit a report to the FDA, and the agency must issue an order finding the product substantially equivalent to a predicate tobacco product.[15] To be exempt from the substantial equivalence requirement, the manufacturer must submit a report establishing that all modifications are covered by exemptions.[16]
In virtually every warning letter for a tobacco product issued during the period under consideration, the FDA cited the manufacturer because their e-liquid products were considered new tobacco products, but did not have the required premarket authorization, and were not subject to an exemption from the rule.
As a result, the products were considered adulterated under Section 902(6)(A) of the FDCA. The agency also flagged many of these products for being misbranded under Section 903(a)(6) of the FDCA, because a notice or other information respecting these products were not provided as required by Section 905(j) of the FDCA.
Manufacturers are responsible for ensuring their tobacco products and all related labeling and/or advertising — including on websites, social media and search engines — comply with each applicable provision of the FDCA and the FDA's implementing regulations. In many of the recent warning letters, the agency acknowledges that the recipient is a registered manufacturer with thousands of products already listed with the FDA.
As is customary in the case of most FDA warning letters, the agency has typically provided 15 working days for companies respond. Failure to address any violations may lead to regulatory action — including, but not limited to, civil money penalties, seizure and/or injunction.
Because many of these companies already maintain authorizations for other tobacco products, they run the risk of additional regulatory scrutiny and negative action when they are flagged for selling unauthorized products.
Miscellaneous
A handful of other divisions within the FDA issued warning letters during this same time period. For example, the Center for Food Safety and Applied Nutrition flagged manufacturers and retailers for marketing natural and homeopathic remedies and other dietary supplements that have not been approved by the FDA or approved to treat the listed diseases or conditions.
The agency's Division of Northeast Imports and Division of West Coast Imports also warned importers of problems related to food products imported for sale in the U.S. Finally, the Office of Prescription Drug Promotion warned both a prescription drug and a medical device manufacturer of problems with advertising and marketing materials that failed to adequately convey the risks of products.
Conclusion
As the global pandemic continues, companies marketing products claimed to treat or prevent COVID-19 must be exceptionally cautious about risks of negative regulatory action. The products in question include both overtly marketed products, like an essential oil advertised to treat COVID-19 symptoms, and indirectly marketed products, like temperature monitoring systems designed to passively monitor for fevers, and hand sanitizers.
Likewise, tobacco products — especially related to vaping — are receiving exceptional regulatory scrutiny. Companies marketing products in both of these categories should be particularly cautious of applicable federal regulations, to avoid negative action.
Katie Insogna is a partner at DLA Piper.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] The CFSAN issued five letters to manufacturers or retailers marketing vitamins and teas that purport to be safe and/or effective for the treatment or prevention of COVID-19.
[2] See https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products.
[3] The CDRH's other three Warning Letters during this period also were directed at manufacturers of telethermographic devices, but those were not specifically marketed for COVID-19 diagnosis.
[4] 21 U.S.C. § 321(h).
[5] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/thermoteknix-system-limited-613565-03042021.
[6] 21 U.S.C. § 355(a).
[7] 21 U.S.C. § 352.
[8] 21 U.S.C. § 331(a) and (d).
[9] 21 U.S.C. § 321(rr).
[10] 21 U.S.C. § 387a(b)); 21 C.F.R. § 1100.1.
[11] See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.
[12] 21 U.S.C. § 387j(a).
[13] Id.
[14] See generally 21 U.S.C. § 387j(c)(1)(A)(i).
[15] 21 U.S.C. § 387e(j).
[16] 21 U.S.C. § 387e(j)(1)(A)(ii); 21 U.S.C. § 387e(j)(3)).
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