Tag: FDA

Stroud: Preventing Youth Use Should Rely on Data

By Lindsey Stroud
In 2018, the U.S. Food and Drug Administration (FDA) and then-Surgeon General Jerome Adams declared a so-called youth vaping epidemic. Lawmakers across the country, from city council members, to state leaders, to Congress, have been attempting to reduce youth use of e-cigarettes and vaping products ever since, Lindsey Stroud wrote for Inside Sources. Addressing youth use of any age-restricted product is laudable, but it should not come at the expense of adult users of such products. And all policies introduced by well-intended lawmakers threaten adult access either through bans, arduous regulations, or unfair taxation.
A quick glance at existing data on youth e-cigarette use finds many of these “solutions” fail to address the real reason why youth use e-cigarettes. Officials completely disregard that youth smoking rates are at all-time lows. Such legislation threatens adult access to tobacco harm reduction products and is unlikely to reduce youth e-cigarette use.
Take, for example, the impending ban on mailing vapor products. Crammed into the 5000+ pages of the December 2020 COVID-19 relief bill was an amendment to include electronic cigarettes in the Prevent All Cigarette Trafficking (PACT) Act. Not only will the new regulation ban the shipment of e-cigarettes in USPS mail it will also require retailers to register with the Bureau of Alcohol, Tobacco, Firearms and Explosives, as well require sellers, to submit monthly reports to the state agency that handles tobacco taxes in all states where their products are sold.
Lindsey Stroud

The amendment was introduced by Sen. Dianne Feinstein (D-CA), who erroneously claimed “[b]uying e-cigarettes online is one of the easiest ways for children and teens to get their hands on these harmful products.”
Several state-based youth surveys have shown youths are not relying on the internet to obtain e-cigarettes. For example, in 2019, in Vermont, among current e-cigarette users, only three percent of high school students under 18 years of age reported buying vapor products online. Conversely, 52 percent of minors reported borrowing e-cigarettes. In aggregate data of all students from five different state high school surveys including Arkansas, Maryland, Montana, New Hampshire, and Rhode Island, only 0.9 percent of high school students reported purchasing vapor products from online retailers. With very few youths using the internet and mail to obtain e-cigarettes, a ban on the shipment of such products is highly unlikely to reduce underage e-cigarette use.
The mail ban isn’t the only flawed “solution” proposed by lawmakers. Many localities and states have banned, or are attempting to ban, the sale of flavored vapor products. Yet again, the data overwhelmingly indicate youth use e-cigarettes because of “other” reasons and because friends and family members use them. For example, in the aforementioned Vermont survey, when asked about the “primary reason” for using e-cigarette products (among current users) only 10 percent reported “flavors,” compared to 51 percent who cited “other,” and 17 percent who cited friends and family. This data is similar to other states including Connecticut, Hawaii, Maryland, Montana, Rhode Island, and Virginia.
Again, banning flavors is unlikely to reduce youth use of e-cigarettes and it may also have adverse effects. In San Francisco, which banned the sale of flavored e-cigarettes in 2018, youth vaping still increased after the ban, but so did youth smoking rates. In fact, current combustible cigarette use among high school students increased from 4.7 percent of San Francisco high school students in 2017, to 6.5 percent in 2019.
In order to protect adult access, youth use of e-cigarettes and vapor products must be addressed, but bans are ineffective measures and ultimately punish adults. States do have one solution in place, borne by the pockets of the very smokers that are trying to quit by using flavor vapor products: the monies received from tobacco taxes and settlement payments.
Each year, states allocate a pitiful amount of existing tobacco dollars towards tobacco control measures, including cessation, education, and youth prevention. In 2019, states collected an estimated $16.7 billion in cigarette taxes and $6.2 billion in tobacco settlement payments, yet spent only $655 million in state funding on tobacco control programs. This is a paltry 3 percent.
Given the lack of funding dedicated towards programs to help smokers quit, policymakers should embrace e-cigarettes as they have been more effective at reducing smoking than the insufficiently-funded tobacco control programs.
As a tool that has helped millions of American adults quit smoking, lawmakers must avoid policies that preventing adult access to e-cigarettes and vapor products. They must also rely on existing data on why youth are using e-cigarettes when putting forth policies to limit youth e-cigarette use. To fail to do so harms millions of American adult smokers – and former smokers – and fails to reduce youth use.
Lindsey Stroud is the creator and manager of Tobacco Harm Reduction 101 (www.thr101.org), a website that provides analysis and insight on tobacco and vapor products.
March 23, 2021
Analysis of Potential Nominees for U.S. FDA Leadership
As the Biden administration engages the COVID-19 pandemic, a public tug-of-war has emerged over who should be nominated to run the Food and Drug Administration, a pivotal participant in the effort, write Henry I. Miller and Jeff Stier for Issues & Insights. An analysis of the two perceived front-runners illustrates that neither would likely introduce the kinds of reform needed at the agency.
Jeff Stier / senior fellow at the Consumer Choice Center
One candidate is acting Commissioner Dr. Janet Woodcock, a long-serving top FDA official with widespread institutional respect, both inside and outside the agency.
To her (far) left is Dr. Joshua Sharfstein, who served briefly as deputy commissioner of the FDA in the Obama administration, and who formerly was the secretary of the Maryland Department of Health, as well as the health commissioner in Baltimore. Earlier in his career, Sharfstein was the health policy adviser to influential, liberal Congressman Henry Waxman, D-Calif. He is currently the vice dean for Public Health Practice and Community Engagement at the Johns Hopkins Bloomberg School of Public Health.
Woodcock’s strength is her extensive background in pharmaceutical regulation. However, some perceive her to be overly sympathetic to industry. Woodcock has been at the FDA for 35 years, and would be a sober, steady influence at a time that cries for stability at the agency.
But her institutionalism is also a weakness; all is not well at the FDA. As former Commissioner Frank E. Young quipped, “dogs bark, cows moo, and regulators regulate.” Consistent with that propensity, the FDA often exceeds its congressional mandate. Regulators have concocted additional criteria for marketing approval of a new drug beyond the statutory requirements for demonstrating safety and efficacy— requirements that sometimes inflict significant but obscure damage on both patients and pharmaceutical companies.
For example, regulators have arbitrarily demanded that a new drug be superior to existing therapies, although the Food, Drug and Cosmetic Act requires only a demonstration of safety and efficacy. And in a classic case of regulatory mission creep, Phase 4 (post-marketing) studies are now routine, whereas the FDA used to reserve them for rare situations, such as when there were subpopulations of patients for whom data were insufficient at the time of approval.
The effects of FDA regulators’ self-aggrandizing, excessively risk-averse actions range from the creation of disincentives to research and development (which inflates costs) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.
Another egregious example of the impact of excessive risk-aversion is the saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been judged to be safe and effective and marketed in Europe, Japan, Canada, and China. (This deadly delay occurred on the watches of both Woodcock and Sharfstein.) As a result, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.
The agency’s handling of e-cigarettes over the last two administrations is a sorry illustration of how regulatory dilly-dallying undermines public health. The agency’s mealy-mouthed endorsement of vaping as only a “potential” tool for tobacco harm reduction for adult smokers failed to sufficiently encourage smokers to make the switch away from consuming nicotine in its deadliest form, the cigarette. As a result, not enough smokers have been using them, while too many kids have.
Contrast this with Public Health England’s clear endorsement of using e-cigarettes to quit smoking, which has led to a sharp reduction in smoking without an epidemic of youth vaping. Woodcock would be unlikely to break the FDA’s mold in this space, while Sharfstein’s blind opposition to private sector-driven innovative solutions would likely shift e-cigarettes from a highly regulated marketplace to an illicit market like the one that caused the outbreak of pulmonary illnesses related to THC-vaping in 2019.
The agency has become extremely top-heavy, with ever more boxes appearing at the top of the organizational chart, even though the vast majority of day-to-day oversight and regulatory actions are taken at the level of FDA’s various “centers” – Woodcock’s longtime perch, the Center for Drug Evaluation and Research, the Center for Food Safety and Nutrition, the relatively new Center for Tobacco Products, and so on. The FDA needs to be put on an organizational diet.
If Woodcock is the institutional pick, Sharfstein would be the Ralph Nader pick. In fact, Sharfstein’s affiliation with failed nanny-state presidential candidates is more current than that. His academic affiliation with the Bloomberg School of Public Health is no coincidence. An outspoken advocate for expanding the scope of the FDA, which already regulates 20 cents of every consumer dollar, Sharfstein would have been the obvious pick for FDA commissioner, or even secretary of the Department of Health and Human Services, if former New York Mayor Michael Bloomberg’s multi-million-dollar presidential campaign had prevailed. Far from putting the agency on a diet, Sharfstein would instigate a regulatory feeding frenzy.
What’s needed are structural, policy, management, and cultural changes that create incentives for the FDA to regulate in a way that is evidence-based and imposes the minimum burden possible. A number of possible approaches and remedies to accomplish that have been described, but neither Woodcock nor Sharfstein is likely to embrace any of them.
We need significant legislative changes, or just conscientious congressional oversight, to disrupt the agency’s built-in bias for overregulation, but political realities make that unlikely anytime soon.
Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. A 15-year veteran of the FDA, he was the founding director of the agency’s Office of Biotechnology. Jeff Stier is a senior fellow at the Consumer Choice Center. Please follow them on Twitter at @henryimiller and @JeffAStier.
March 23, 2021
FDA Issues its 69th Vapor PMTA Warning Letter This Year
The US Food and Drug Administration (FDA) issued three more warning letters to vapor industry companies on March 19. The latest announcement total brings the count to 69 letters this year for companies selling vapor products without gaining regulatory approval through the agency’s premarket tobacco product application (PMTA) process, according to the agency’s website.
The latest letters were issued to Arizona-based Vapor Outlet, Vapor Tech Hawaii and the Vaporium in Illinois. In its letter to Vaporium, the FDA stated that the company continues to “manufacture, sell, and/or distribute to customers in the United States The Vaporium 6mg Red White and Blue 70/30 30 ML e-liquid product” without a marketing authorization order.
“Your firm is a registered manufacturer with 19,860 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states. “Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
Many of the FDA’s letters so far have gone to local vape shops that manufacturer their own e-liquid in the store. For example, Vapor Tech Hawaii’s letter states that the FDA has determined that it “manufacture, sell, and/or distribute to customers its Vapor Tech Hawaii Waikikiwi 100ML 3mg e-liquid product” without a marketing authorization order. On March 16, the company issued three letters to stores owned by the Louisiana-based Little Town Vaping for selling house brand e-liquids.
March 22, 2021
Becerra Confirmed Secretary of Health And Human Services

Xavier Becerra (Photo: State of California Department of Justice)
The U.S. Senate on Thursday narrowly confirmed Xavier Becerra as President Biden’s secretary of Health and Human Services (HHS), reports The New York Times.
Becerra will take charge as the Biden administration is working to lead the nation out of the coronavirus pandemic.
Biden’s selection of Becerra was a surprise, and it set off an immediate debate over whether, as a lawyer, he was the correct choice to lead a department that oversees high-profile medical agencies, including the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. Republicans argued he was unqualified.
Democrats argued that Becerra had deep expertise in health policy. As California’s attorney general, he led 20 states and the District of Columbia in a campaign to protect the Affordable Care Act from being dismantled by his Republican counterparts. He has also been vocal in the Democratic Party about fighting for women’s health, including access to contraceptives and abortion.
In a tweet earlier this year, Derek Yach, president of the Foundation for a Smoke-Free World, described the nomination of Becerra as a “serious missed opportunity.”
“At a time of public health crisis, deep expertise in public health, medicine and science should matter,” Yach wrote. “Sadly, this is not apparent in the pick of the lead cabinet health voice.”
James A. Mish, CEO of 22nd Century Group, welcomed Becerra’s appointment, citing his leadership in tackling cigarette addiction.
According to Mish, Secretary Becerra is a long-time proponent of a reduced nicotine cap for cigarettes and tougher regulation for the tobacco industry. While serving as the attorney general of California in 2018, Becerra and five other attorneys general wrote a letter in response to the FDA’s Advance Notice of Proposed Rulemaking, strongly supporting a tobacco product standard for the nicotine level of combusted cigarettes.
“We look forward to joining Secretary Becerra, the HHS and the FDA on tackling the pressing public health tragedy caused by addictive cigarettes that is costing millions of Americans’ lives and billions of dollars each year,” said Mish in a statement.
March 19, 2021
Nicopure’s Halo PMTAs Move on to Substantive Review
The U.S. Food and Drug Administration has accepted all of Nicopure Labs’ Halo products’ premarket tobacco product applications (PMTA) for the substantive scientific review phase.
Just over six months after submission, Nicopure Labs’ PMTAs for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit and all supporting consumable components have been accepted and advanced to the final phase, substantive scientific review, by the FDA. Halo FDA accepted premarket tobacco product applications include:

Halo Tribeca Tobacco e-liquid

Halo SubZero Menthol e-liquid

Halo Turkish Tobacco e-liquid

Halo Fusion Unflavored Tobacco e-liquid

Halo Triton II Starter Kit (and supporting consumable components)

Halo ZERO Starter Kit (and supporting consumable components)
Halo’s first round of products was accepted and advanced three days after submission.
“Halo’s more than 12 years of commitment to producing the highest quality vaping products available for adult consumers has been our organization’s mission for more than a decade,” said Jeffrey Stamler, co-founder of Nicopure Labs, in a statement. “We believe in science, and we believe in transparency; we are honored to continue to work with the FDA, and as always, in the best interest of the industry and the most important thing of them all, our loyal customers.”
March 19, 2021
Retail Resource

Vapor Voice, in partnership with TMA, has created a tool to track PMTA submissions as they make their way through the review process.
By Timothy S. Donahue
The world is waiting. When premarket tobacco product applications (PMTA) were due to the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Sept. 9, 2020, the vapor industry wanted to know what companies had submitted the required data and could remain in the U.S. market legally. In response, the CTP stated it would release a list of products that may continue to be sold during the review process.
Nearly five months later, the CTP has yet to produce anything to help the retailers, wholesalers, manufacturers and suppliers. In late January 2021, CTP Director Mitch Zeller said that the FDA would release the information in the “coming weeks.” Zeller has also said that “thousands” of PMTAs were submitted. Meanwhile, the CTP has stated that before making such a list available, the agency needs to ensure that publishing any such information complies with federal disclosure laws.
The CTP did finalize PMTA and substantial equivalence rules (SE) meant to guide how a manufacturer can seek a marketing order for electronic nicotine-delivery systems (ENDS). The text of the final rule was published long after the provisional PMTA submissions were due. Then, nearly a week after its posting, the new Biden administration froze all new and pending rules introduced in the last part of the Trump administration, including the just-finalized PMTA rule. The rule was removed from the Federal Register prior to its effective date.
“While a memo from the White House chief of staff ordered the withdrawal of any rules that did not publish by noon on Jan. 20, 2021, and the PMTA and SE final rules were withdrawn, this does not impact the FDA’s review of PMTAs or SEs that the agency has received,” an FDA spokesperson told Vapor Voice. “The agency continues to process the large number of submissions received and has already begun reviewing many applications. In the coming weeks, the FDA intends to provide a more detailed update on the agency’s progress since the Sept. 9, 2020 deadline.”
The FDA spokesperson says the agency will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.
To help stakeholders gain some visibility on this crucial issue, Vapor Voice partnered with data specialists TMA to locate and confirm who has submitted PMTAs and at what stage the application is in in the regulatory process. The PMTA list can be found here.
Because there is no central, publicly available database, the information had to be pieced together from multiple sources, according to TMA research assistant Karen Pace. Several organizations issued press releases as their PMTAs moved through the process. Many others did not. Pace says that Vapepmta.com, an online resource also attempting to collect PMTA information, has been a valuable resource in her research.
“Not all of the press releases are as specific as others,” says Pace. “I tried to research those that had minimal information. Sometimes that worked, sometimes I could not find anything more. Then I found Vapepmta.com. The site was extremely helpful and is where I gathered most of the information. It was still a challenge to gather information on the total number of submissions a company had and the actual products submitted.”
It was also difficult to know what brands and how many flavors or nicotine strengths (or even if a submitted product used a freebase or salt nicotine) a company submitted. Pace says the only way to know for sure about some submissions was to go to the source. “We checked corporate websites and also called or emailed the companies directly to verify submissions,” she says. “It is something we will continue to do moving forward as we update the listing.” In the end, Pace choose to list companies individually and list the brands submitted when possible. “We are going to need help from the industry in keeping the information accurate and up to date,” she says.
The Vapepmta.com team built and operates its platform and has no affiliation with the FDA or any other company. Dan Daniel Racowsky has been in the industry for more than five years and says limited information and confusion around PMTAs led the group to take on the task of building a PMTA listing.
“It wasn’t very challenging to gather data upfront. After launching, we gained some publicity and were flooded with inquiries from brands asking to be included in our database,” Racowsky said. “Somewhat of a challenge has been keeping our data as accurate as possible. We’re in direct contact with the majority of brands listed on our platform, and most are pragmatically keeping us informed on their PMTA’s progress.”
The list is a solid source for interested parties, however, it is impossible for VV/TMA to guarantee its complete accuracy. While many companies have confirmed the accuracy of their listings, in some cases we have not been able to reach the applicant.
“We put in a lot of effort to validate these submissions, but there are still some companies that haven’t returned calls or emails to confirm their listing,” says Taco Tuinstra, editor-in-chief for Vapor Voice. “We note those instances in the list.”
If you note inaccuracies in your listing, please send an email to pmta@vaporvoice.net and we will be pleased to update the information.
Methodology explained
Thousands of manufacturers and importers submitted premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) by the Sept. 9 deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.
In the absence of an official database, Vapor Voice decided to create its own tracker. As a news outlet, we already receive many press releases relating to PMTA submissions. In addition, we continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.
Of course, this approach has its limits. The data is self-reported, and at present, we cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches us also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per our protocol, these issues are noted in the list. While we cannot present our dataset as a representative sample, we believe that, after capturing information on 180 companies, it paints as coherent a picture as possible.
Our tracker lists company, brand family, brand styles and PMTA stage. We view it as a “living document” that will be updated as new information becomes available. To that end, the tracker also includes a tool for user input. If the status of your application has changed or if you notice inaccuracies, we invite you to share that information with our editors, who will be pleased to make the required updates.
Keeping in mind the limitations of our tracker, we recommend using this tool to gain directional understanding of the volume of submissions for which the FDA’s Center for Tobacco Products is processing and as a starting point in a comprehensive due diligence search regarding products. We also strongly recommend that any retailer gain certification of products in their inventory from the manufacturer and rely upon advice of counsel as to appropriate due diligence and safe harbor.
View the tracker.
March 15, 2021
U.S. FDA Warns 13 Companies for Illegal E-Liquids
On March 12, the U.S. FDA issued warning letters to 13 firms who manufacture and sell unauthorized e-liquids. The regulatory agency advised the companies that selling products lacking a premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.
Credit: Isaiah Rustad

The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline, according to a press release from the FDA. The firms receiving warning letters are VapinUSA-WI, LLC d/b/a VapinUSA, Vapor Springs, LLC, Vapor Cigs, LLC, Vegas Vapor Emporium, LLC, Vape 911, The Philosopher’s Stone, LLC, The Clean Vape, Tooters Vape Shop, Cloudchasor LLC, Boardwalk Elixir, LLC, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors LLC, and Revolution Vapor LLC.
“While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA,” the statement reads.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for products that failed to submit a PMTA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
March 15, 2021
2 Cases Ask SCOTUS to Take Away FDA’s Vapor Rules
The litigants in two lawsuits challenging the constitutionality of the the U.S. Food and Drug Administration’s (FDA) Deeming Rule for vapor products have asked the Supreme Court of the United States (SCOTUS) to take up the cases.
The cases are Big Time Vapes, Inc., et al. v. FDA, and Moose Jooce, et al. v. FDA.
Attorneys for the plaintiffs in the Moose Jooce case filed a petition for writ of certiorari, a request to have the U.S. Supreme Court consider the case. On February 26, 2021, the Moose Jooce challengers filed their petition asking the Supreme Court to take up questions related to their challenge to the Deeming Rule under the “Appointments Clause” in Article II, § 2 of the Constitution.
The plaintiffs claim that FDA acted improperly because the person that issued the deeming regulations was not qualified to do so per the Appointments Clause. In this case, the rule was issued by Leslie Kux, the associate commissioner for policy, and not the commissioner himself, according to an attorney for Troutman Pepper.
FDA has argued that the commissioner—in both 2016 and 2019—ratified the regulations. Both the U.S. District Court for the District of Columbia and the U.S. Court of Appeals for the District of Columbia have ruled against plaintiffs in the Moose Jooce case. The district court and court of appeals held that these circumstances did not render the Deeming Rule invalid. The plaintiffs are represented by the Pacific Legal Foundation.
In the Big Time Vapes case, the challengers petitioned the Supreme Court for a writ of certiorari on December 18, 2020. The case involves the claim that the statute purportedly authorizing the Deeming Rule is an unconstitutional delegation of Congress’ legislative power.
The challengers in the Big Time suit initiated their case in the U.S. District Court for the Southern District of Mississippi. The court granted the FDA’s motion to dismiss and denied the challengers’ motion for preliminary injunction and the Fifth Circuit affirmed the decision.
There is no guarantee that the Supreme Court will take up these cases. According to the Administrative Office of the U.S. Courts, the court accepts 100-150 of the more than 7,000 requests it receives each year.
The FDA will have the opportunity to respond to the challengers’ petitions before the Supreme Court acts on them. Review “is not a matter of right, but of judicial discretion,” and the petitions “will be granted only for compelling reasons.”
Currently, vapor businesses are still subject to the Deeming Rule.
March 9, 2021
Howard: CBD Market to See Regulatory Uptick in 2021

The Covid-19 pandemic slowed the regulatory process in 2020, creating an expected uptick in 2021.
By Chris Howard, special to VV
After CBD’s explosive growth in 2019 following the passage of the 2018 Farm Bill that legalized hemp, 2020 began navigation of a regulatory environment in flux. Burgeoning federal and state regulation, as well as increased research into consumer trends and tastes, begins outlining the future of CBD.
The Covid-19 pandemic slowed progress in the U.S. Food and Drug Administration’s (FDA) decision making around CBD, setting up 2021 as a crucial year for the industry, although it is unlikely that any FDA regulations will be finalized this year. Vapor industry veterans, who witnessed the regulatory battles with the FDA, are rightfully wary of the government’s efforts to oversee CBD, but the initial steps seem promising. It is still early days for the CBD industry, and the FDA appears willing to collaborate with the industry on many issues that are important to manufacturers and retailers alike.
As we look ahead, I offer some thoughts on the current CBD market, where regulatory efforts are and finally, what to expect as the CBD space matures.
State of the market
After CBD’s rise to prominence in 2019, last year represented more incremental growth. According to the Brightfield Group, a leading cannabis and CBD market research provider, the United States CBD market grew from $627 million in 2018 to over $4 billion in 2019, an increase of over 650 percent. In 2020, market growth slowed to 14 percent as CBD could be found in more stores and additional uncertainty caused retailers to tread carefully. Despite this recent modest growth, the Brightfield Group projects the CBD market will continue to grow from $4.7 billion in 2020 to nearly $15 billion by 2024.
Driving this growth is a mixture of increased consumer awareness and interest as well as improved access. Sales continue to increase in key market areas, especially e-commerce, creating more competition for CBD specialty stores and vape shops selling these products. C-stores were previously well positioned to capitalize on the market, but research from Technomic, a management consulting company, shows that consumers are being selective where they shop to better hand-pick CBD products.
Chris Howard
Consumer form factor preference (the types of products available containing CBD) has been another important area of analysis. Tinctures remain popular, especially with new CBD users. Lotions have become a huge source of interest for consumers with many over-the-counter topical, beauty and skin care companies investing heavily in these products. Refining offerings will be a key part of crafting common sense regulation and helping CBD companies make more confident investments in their product lines.
Regulations in 2021
It is no surprise that the FDA took significant interest in CBD as it quickly grew from an industry valued in the hundreds of millions to one worth billions. Yet, the agency has been slow to definitively rule on any regulations apart from taking a firm stance against companies making therapeutic or health claims, especially during the pandemic.
Where does that leave us now? The FDA’s studies into CBD are ongoing, both analyzing the effects of the compound as well as auditing the contents of current products, although progress has slowed due to Covid-19. Meanwhile, there remains some pressure from congress to create policy around CBD to act as a stopgap while the FDA creates long-term guidance.
I remain optimistic that the FDA will introduce a framework for the specific purpose of regulating products containing CBD that permits the marketing and sale of all form factors in the U.S. This includes food and dietary supplements, a source of much back and forth between CBD advocates and regulators. That said, it is unlikely that a rule will be finalized in 2021. I expect this to be subject to a lot of discussion this year. We will find out more based on how the Biden administration addresses CBD in the year ahead.
In the meantime, CBD companies are forced to navigate a labyrinth of state-by-state regulations. CSP and Grocery Business research indicates 46 states have created CBD laws. State laws can run directly counter to existing federal guidelines, such as those concerning food and beverage products—which are prohibited federally but which are permissible for sale within some states. The patchwork created by these various regulations continues to make national distribution of CBD products a challenge and in some cases even threatens the supply chain of hemp growers and manufacturers.
Looking ahead
While we await final FDA guidance on CBD, I see companies in this industry dealing with many of the same issues we’ve seen over the years in the vapor industry.
The cost of entry for many in the space will become increasingly burdensome once the FDA begins setting regulations, forcing many smaller CBD companies to exit the market. This is similar to what we have seen with PMTAs in vapor, where the larger companies have been far more well equipped to maintain a compliant product selection.
Although it has not been a concern yet, CBD companies should remain mindful and vigilant to ensure that they are taking the necessary steps to prevent youth use of CBD products. Taking a proactive stance now and preventing youth use will help avoid many of the issues faced by the vapor category over the past two years.
Although there are many complex considerations with CBD, it is hard not to get excited about this industry’s future. With continued strong market growth and an apparent pathway to sensible regulation from the FDA for sellers and consumers alike, the future remains bright. In 2021, I hope to see more progress from regulators as we continue to create a strong framework that will work to the benefit this industry and consumers for years to come.
Chris Howard is vice president, general counsel and chief compliance officer for E-Alternative Solutions.
March 5, 2021
Altria: FDA Must Clarify Nicotine Misperceptions
The Altria Group Inc. asked the U.S. Food and Drug Administration (FDA) for its help in convincing Americans that nicotine isn’t linked to cancer. In a letter to the regulatory agency, the maker of IQOS and Juul products asked for the FDA to assist in combatting misperceptions about nicotine as part of a proposed $100 million advertising campaign to reduce the harm caused by tobacco.
According to a letter seen by Bloomberg, Altria states that nearly three-fourths of U.S. adults incorrectly believe nicotine causes cancer, citing government research. Clearing up the drug’s health risks will be key to the agency reducing smoking combustible cigarettes because it will help convince cigarette users to switch to noncombustible options for nicotine, the company said.
While there are at least 60 well-established carcinogens in cigarette smoke, it’s been known for years that nicotine isn’t the direct cause of many of smoking’s ills. The drug has even been touted as a way to ease tension and sharpen the mind. But nicotine is the ingredient that addicts people to tobacco products, and it has risks, according to the National Institute on Drug Abuse, a government agency.
The FDA “should commit resources and expertise to correct the deeply entrenched public misperceptions regarding the health risks of nicotine,” Paige Magness, Altria’s senior vice president of regulatory affairs, said in the letter dated Feb. 25. Such a campaign would help the agency by getting more smokers to use noncombustible offerings that “may present lower health risk,” according to the letter.
The FDA declined to comment, according to Bloomberg.
March 4, 2021