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Month: October 2021

FDA’s Authorization Of Vuse Solo Is A Bittersweet Victory For Vapers

On October 12th, the Food and Drug Administration authorized the marketing of the Vuse Solo device — a type of e-cigarette — and its tobacco-flavored e-liquid pods, both produced by R.J. Reynolds. The authorization marks the first-ever decision in favor of vaping by the FDA. Preceded by over a million rejections of authorization requests from smaller companies, the FDA’s Vuse Solo decision is both a reason for celebration and reflection. 

The good news is that the FDA finally recognized that harm reduction is a central feature of e-cigarettes. The rationale for approving Vuse Solo products was that “tobacco-flavored products could benefit addicted adult smokers who switch to these products.” So e-cigarettes were found to be consistent with the protection of public health. Yay! It only took the FDA two years of onerous reviews and bureaucratic chaos to get there, proving once again that FDA authorization is much more about a company’s ability to navigate red tape over science. 

Building and submitting a market authorization application takes an average of 1,713 hours to compile and could cost several million dollars per product. That presents a challenge for all vaping companies, but the bureaucratic burden has been insuperable for the smaller ones. None of them has managed to pass the FDA’s test, and the grounds for that are scientifically unjustified.

The FDA has used e-cigarettes’ supposed “appeal to young people” as a justification for PMTA rejections. However, smoking rates among minors have been dropping in the US, despite the FDA’s, CDC’s, and Michael Bloomberg’s determination to twist the latest National Youth Tobacco Survey results to their advantage. Between 2019 and 2021, the use of electronic cigarettes among teens more than halved: 27.5% to 11.3%. 

Contrary to the FDA’s misleading reports, only 3.1 percent of high school students and less than 1 percent of middle school students use vapor products daily. Recent studies found that vape flavor restrictions make teens take up smoking. 

Not to mention that reducing accessibility to vaping products negatively impacts adult smokers who are stripped of the opportunity to switch. Using flavors has been associated with a 2.3 times higher likelihood of quitting than the use of tobacco-flavored cigarettes. To protect public health, the FDA should ensure that a vast majority of products are available on the market.

The FDA made the historic e-cigarettes marketing approval process all about resources, while it should have been about smokers and harm reduction. E-cigarettes are safe, and now that the FDA recognized it in the case of one company, the trend should get replicated across the board, regardless of size and standing.

Originally published here

David Clement On Big Talker discussing “One Size Fits All” regulations

Our North America Affairs Manager David Clement was a guest on Mornings With Joe Catanacci on the BigTalker 106.7FM discussing our “One Size Fits All” Doesn’t Fit At All campaign.

Check out “One size fits all” Doesn’t fit at all policy note

Three years on, we need to relax cannabis regulation

Moving away from the ‘one size fits all’ approach would help make Canada’s legal cannabis market more consumer-friendly Author of the article:

Three years ago Sunday (October 17, 2018), Canada legalized adult-use recreational cannabis. The Trudeau government deserves credit for making this happen, as most Canadians had for some time believed that the consequences of prohibition outweighed whatever negatives would arise from legalization. That said, the Cannabis Act is now three years old, and it needs to be amended to make the legal cannabis market more consumer- and patient-friendly.

A good first step would be to remove “CBD” products from the Cannabis Act altogether. CBD stands for “cannabidiol,” a chemical found mainly in hemp, which itself is low in THC. On its own, CBD has a variety of medicinal and wellness uses. CBD is used to treat seizures, joint pain and inflammation, and as a sleep aid. Because CBD products are not psychoactive and have a significantly lower risk profile they shouldn’t be regulated the same as cannabis products containing THC. Any CBD product with a THC concentration of less than 0.3 per cent (the U.S. legal standard) should be treated as a natural health product. Moving away from the “one size fits all” approach would help make Canada’s legal cannabis market more consumer-friendly in a number of ways.

First, it would exempt CBD products from the heavy-handed marketing, branding and packaging restrictions set out in the Cannabis Act. Regulating cannabis like tobacco rather than alcohol was a huge mistake, given the differences in risks between the two products. But treating CBD products like tobacco is downright silly.

Beyond chipping away at the paternalism built into the Act, exempting CBD would dramatically increase consumer access. The markets for CBD wellness products and beverages, including sports drinks, likely would expand significantly, especially if these products could be sold outside of licensed cannabis retailers, which in many provinces are in short supply. Even in Ontario, which has opened up retail access, some cities — Oakville is one — have maintained their cannabis retail ban. Under a looser regulatory regime, CBD products would be beyond the reach of nanny-state local councilors.

On the industry side, removing CBD products from the Cannabis Act could help reduce the current glut of over one billion grams of cannabis. Freeing the CBD market from the Act would allow producers with too much cannabis on their hands to simply extract the THC and make CBD products.

Reform of the Act should also address the excise tax system for cannabis. Medical cannabis should be exempt, period. We don’t have extra taxes for other medicines. Why this one? Removing the tax may also have the benefit of encouraging medical patients to purchase legal medical cannabis, rather than be pushed into growing their own with a Health Canada permit, an avenue that has regularly been found to be supplying the illicit market.

For recreational users, the $1/gram excise tax should be replaced with a floating percentage. The minimum excise of $1/gram artificially inflates prices, limits the availability of discount brands, and hurts the craft cannabis industry. More competition on price would obviously benefit consumers, but it would also help chip away at black market sales, which are still running at $750 million a year.

Finally, the act should be amended so that the rules for cannabis marketing and promotion are the same as those for alcohol. A legal cannabis brand should be allowed to sponsor events, advertise more broadly, creatively brand its packages, use spokespeople or endorsements, and provide discounts and other inducements for sales — all of which are allowed for alcohol.

To their credit, some provinces have done what they can to make their legal cannabis market more consumer friendly. Ontario, for example, has made significant progress in expanding retail access, and has just committed to permanently legalizing curbside pickup and delivery for cannabis retail stores. These changes at the provincial level are in large part why legal cannabis sales surpassed illegal sales for the first time in the third quarter of 2020.

The provinces seem to be committed to expanding consumer access. With the Cannabis Act now three years old, it’s time for the federal government to step up, too.

Originally published here

Complete PFAS ban not feasible: the EU needs a different approach

Brussels, Belgium – Yesterday, a stakeholder consultation led by the Netherlands, Germany, Denmark, Sweden, and Norway on the use of PFAS (per- and polyfluoroalkyl substances) closed. 

The prospect of an EU PFAS ban is as real as ever, with a number of green groups skewing the discourse towards complete avoidance. In the US, the situation is hardly different, where the PFAS Action Act will soon face a final vote in the Senate.

In response, the Consumer Choice Center’s Maria Chaplia and David Clement published articles in The Parliament Magazine and Real Clear Markets arguing that “while manmade chemicals have their risks, that risk level ultimately depends on each use case and exposure.”

Key points raised in the articles:

“PFAS can be found – but not limited to – in household items and other consumer products, medical equipment, food packaging, and firefighting foam. Their popularity can be explained by their unique qualities, such as chemical resistance and surface tension lowering properties. PFAS’ effectiveness has made them hard and costly to replace”, argue Maria Chaplia and David Clement.

“Some PFAS ban/restrictions might very well be needed and justified but banning an entire category of evolving products won’t serve the consumer. A more appropriate response would be to evaluate these chemicals and substances based on the risk they present and how they are used, rather than lumping them all together and risk enacting bad policy that will have a myriad of consequences”, said Chaplia and Clement

“For example, some of these chemical compounds are vital for contamination-resistant gowns and drapes, implantable medical devices, stent grafts, heart patches, sterile container filters, needle retrieval systems, tracheostomies, catheter guide wire for laparoscopy and inhaler canister coatings. To ban all these chemical compounds, without evaluating the risk associated with each use, puts lifesaving medical technologies in jeopardy and patient safety at risk” 

“Heavyhanded PFAS regulations will also jeopardize the EU smartphone market, used by the vast majority of  Europeans everyday. As cell phones and 5G technology continue to grow and require faster speeds at smaller sizes, these compounds are involved in everything from producing semiconductors to helping cool data centers for cloud computing. Forcibly removing these chemicals from the production process, especially because they present very little risk to humans, will drastically disrupt supply chains and inflate costs that will hurt low-income people the hardest.” argue Chaplia and Clement

John Oliver’s “One Size Fits All” Approach For PFAS Is Misguided

Washington, DC –  British showman and comedian John Oliver, known for his punchy and thorough rants on public policy, has set his sights on a new target: man made chemicals, known as PFAS. In his now viral rant, Oliver explains how PFAS chemicals are problematic for human health and wants all of these chemicals to be declared hazardous by law. This is, in fact, what Congress is attempting to do via the PFAS Action Act, which has passed the House and is waiting for a final vote in the Senate.

David Clement, North American Affairs Manager with the DC based Consumer Choice Center urged caution in regards to regulating these man made chemicals: ” While some bans or restrictions might very well be needed and justified, banning an entire category of evolving products won’t serve the consumer. A more appropriate response would be to evaluate these chemicals and substances based on the risk they present and how they are used, rather than lumping them all together and risk enacting bad policy that will have a myriad of consequences.”

“For example, these chemicals are commonly used to create a long list of medical devices and equipment and done so in a way that presents very little risk to human health. To declare all these chemical compounds hazardous, without evaluating the risk associated with each use, puts lifesaving medical technologies in jeopardy and patient safety at risk,” said Clement

“These chemicals are also used in the production process for smartphones, which 270 million Americans currently use. As cell phones and 5G technology continue to grow and require faster speeds at smaller sizes, these compounds are involved in everything from producing semiconductors to helping cool data centers for cloud computing. Forcibly removing these chemicals from the production process, even when they present very little risk to humans, will drastically disrupt supply chains and inflate costs that will hurt low-income people the hardest,” said Clement.

“Rather than a “one size fits all” approach to PFAS, regulators should keep in mind that risk is established by looking at the hazard a substance presents, and the exposure to that hazard. There is a significant difference between the dumping of these chemicals into water ways, which is atrocious and should never happen, and the necessary use of these chemicals in various production processes, which pose little to no risk to consumer health and safety. Failing to see the difference, and lumping all of these modern chemicals into one regulatory basket, will create a laundry list of negative externalities,” said Clement

Sharing Economy Index and its results – SHARING ECONOMY SERIES, PART 4

Welcome to the CCC’s sharing economy series. In this series of short blog posts, I elaborate on what the sharing economy is, present the main findings of the Sharing Economy Index, and look at potential future regulations surrounding these services. 

The Consumer Choice Center recently published the Global Sharing Economy Index 2021, which evaluates 50 cities around the world based on the availability and accessibility of sharing economy services. The index is a one-of-its-kind compilation of applications you can use to improve your city experience and analyses how regulated these services are in each city (whether you need a special permit to operate an Airbnb business or if there are additional taxes levied on the guests).

In the early years of Uber, to become a driver you only needed a car, driving license, and simple registration on their website. As driving Uber did not require special permits or taxi licensing, which can be quite expensive to acquire in certain countries, it allowed Uber to offer the same services at a much lower cost. 

However, according to the index results, as of today, out of 50 cities, there are only a few ones left that don’t require a special permit. In France for example, in order to operate Uber, you have to get a VTC card first (VTC is a French acronym for private chauffeur services that are different from taxis), and registration for the exam will cost you around 200 euros. Becoming an Uber driver might be more complicated now, but it remains a lucrative business and a big competition to traditional taxi services. Which, as we already saw in the previous blog post, isn’t something that taxi drivers are very happy about.

Another shared service discussed in the index, e-scooter, is an affordable and quite fun means of transportation, available in 43 out of 50 cities. Recently, most cities have been trying to regulate e-scooters by banning them from sidewalks, setting speed limits, or introducing a fine system for parking at the wrong locations, as in the case of Norway. Some cities, like Athens, went as far as permanently banning e-scooters altogether, only allowing private ownership of electric scooters.

Interestingly enough, Eastern European countries enjoy more freedom when it comes to sharing economy services. First place in the ranking was shared by post-soviet cities Tallinn and Tbilisi, where not only all the discussed services are available, but they are also less regulated. On the other hand, Western and Central European countries seem to have taken more restrictive approaches, therefore limiting consumer choice. For example, as if covid wasn’t already destructive enough to sharing economy services, Amsterdam decided to ban Airbnb in its historical centre, a decision that was fortunately overturned by the court.

Even in the light of current efforts from governments to regulate this sector, we can say that the sharing economy is here to stay. People have come to appreciate and get used to the comfort and convenience these services bring to our everyday lives. So no matter what new restrictions the governments around the world come up with, we can leave it to the creativity and entrepreneurial spirit of this industry to fight back and readjust.

Why the EU and US shouldn’t follow the green groups advice on PFAS

The European Commission has committed to phasing out man-made chemicals called per- and polyfluoroalkyl substances, also known as PFAS. Initially, the European Chemicals Agency was expected to submit its restriction proposal for firefighting foams this month, but the deadline has now been extended until January 2022. For other uses, the deadline is also2022.

On the other side of the Atlantic, the US Congress is attempting to achieve similar goals through the PFAS Action Act, which is now waiting for a final vote in the Senate. Unsurprisingly, the ban was pushed for by green groups, who tend to confuse hazard with risk, and favour the “ban them all” approach.

PFAS can be found – but not limited to – in household items and other consumer products, medical equipment, food packaging, and firefighting foam. Their popularity can be explained by their unique qualities, such as chemical resistance and surface tension lowering properties. PFAS’ effectiveness has made them hard and costly to replace.

“Forcibly removing these chemicals from the production process, especially because they present very little risk to humans, will drastically disrupt supply chains and inflate costs”

At the same time, the use of PFAS has been linked with various adverse effects, such as infertility, thyroid and liver diseases, when improperly dumped into the water supply. These concerns are justified and shouldn’t be understated or misrepresented. However, as with pretty much everything, it is the amount of exposure that counts towards a risk-based assessment, as opposed to complete hazard avoidance. Because there are more than 4700 chemicals that fall into the PFAS group, and they all carry different levels of risk and hazard, we have to be careful not to put them all in the same basket.

The European Union aims to divide these chemicals into two groups: essential and non-essential, but eventually all are sought to be banned. That said, PFAS have already been largely phased out from being used where they are not necessary. A 2018 Toxicological Profile for Perfluoroalkyls by the Agency for Toxic Substances & Disease Registry says that “Industrial releases have been declining since companies began phasing out the production and use of several perfluoroalkyls in the early 2000s.”

There is no guarantee that phasing out PFAS will make us safer. Both EU and US banned bisphenol A (BPA), a chemical found in plastics, in baby bottles on the premise that it carries health risks for kids. However, BPS and BPF that are typically used as substitutes have been found to be anything but harmless. In fact, even low exposure to BPS had a significant impact on the embryos’ development.

A complete ban on PFAS being used also doesn’t necessarily mean that these man-made chemicals will cease to be produced, it just means that other countries like China will likely ramp up their production. And given how necessary PFAS can be for both medical equipment, and consumer goods, an EU or US ban would be quite problematic.

For example, some of these chemical compounds are vital for contamination-resistant gowns and drapes, implantable medical devices, stent grafts, heart patches, sterile container filters, needle retrieval systems, tracheostomies, catheter guide wire for laparoscopy and inhaler canister coatings. To declare all these chemical compounds hazardous, without evaluating the risk associated with each use, puts lifesaving medical technologies in jeopardy and patient safety at risk.

“Policymakers on both sides of the pond should take a risk-based approach towards the regulation of PFAS rather than falling prey to green activists’ calls for complete avoidance”

On the consumer product side, as cell phones and 5G technology continue to grow and require faster speeds at smaller sizes, these compounds are involved in everything from producing semiconductors to helping cool data centres for cloud computing. Forcibly removing these chemicals from the production process, especially because they present very little risk to humans, will drastically disrupt supply chains and inflate costs for the 472 million Europeans who currently use a smartphone.

Policymakers on both sides of the pond should take a risk-based approach towards the regulation of PFAS rather than falling prey to green activists’ calls for complete avoidance. Although some of these chemicals might need to be banned, or restricted, banning them all might end up leaving us with even worse alternatives that might take a greater toll on our health and wellbeing. These chemicals need a very rigid and detailed regulatory approach, but one that avoids the “one size fits all” lens.

Originally published here

John Oliver’s Misguided Rant About Man-Made Chemicals

British showman and comedian John Oliver, known for his punchy and thorough rants on public policy, has set his sights on a new target: man made chemicals, known as PFAS. In his now viral rant, Oliver explains how PFAS chemicals are problematic for human health and wants all of these chemicals to be declared hazardous by law. This is, in fact, what Congress is attempting to do via the PFAS Action Act, which has passed the House and is waiting for a final vote in the Senate.

While Oliver’s rant does accurately explain some of the serious problems these man-made chemicals present, especially if dumped into waterways and contaminating the water supply, there is a lot that the late night show host misses in regards to how, or why, these chemicals should be regulated.

It is important to note that these chemicals have been largely phased out from being used where they are not necessary. A  2018 Toxicological Profile for Perfluoroalkyls by the Agency for Toxic Substances & Disease Registry says that “Industrial releases have been declining since companies began phasing out the production and use of several perfluoroalkyls in the early 2000s.” In addition to that, a CDC report shows that since 2000, “mean blood levels of PFOS have declined approximately 84 percent and mean blood levels of PFOA have declined about 70 percent,” and recent reports are showing that bodies of water contain only trace amounts of PFAS, and they have been steadily declining. These are all positive developments, and should be celebrated. 

The issue with the “one size fits all” approach, advocated by Oliver and being pushed by Congress, is that this fails to appropriately address the hazards and risks presented by each of the 5000chemicals that fall under the classification of PFAS. This is an important distinction, because the risk that PFAS presents for human health largely depends on how humans are exposed to these chemicals. 

The most popular example is when, decades ago, the man-made chemical C8 was dumped into waterways, causing an array of health issues and substantial lawsuits. This is of course problematic, never should have happened, and should never happen again. That said, the use of other man-made chemicals, which would be classified as hazardous if Congress proceeds down this path, are vital for medical technologies and consumer products, and are used in a way that presents very little, if any, threat to human health.

For example, some of these chemical compounds are vital for contamination-resistant gowns and drapes, implantable medical devices, stent grafts, heart patches, sterile container filters, needle retrieval systems, tracheostomies, catheter guide wire for laparoscopy and inhaler canister coatings. To declare all these chemical compounds hazardous, without evaluating the risk associated with each use, puts lifesaving medical technologies in jeopardy and patient safety at risk. In fact, Congressman Larry Bucshon, who was a heart surgeon, criticized the PFAS Action Act for failing to include a revision that would exempt PFAS use in medical devices, stating that the bill in its current form would jeopardize access to life-saving drugs.

Another major disruption that would occur if the act proceeds as written is it would significantly jeopardize the domestic smartphone market, used by the vast majority of  Americans everyday. As cell phones and 5G technology continue to grow and require faster speeds at smaller sizes, these compounds are involved in everything from producing semiconductors to helping cool data centers for cloud computing. Forcibly removing these chemicals from the production process, especially because they present very little risk to humans, will drastically disrupt supply chains and inflate costs that will hurt low-income people the hardest.

It should be said that lawmakers and late night talk show hosts (yes even them) must realize that regulations are enacted based on risk, and risk is the hazard a substance presents multiplied by the exposure to it. Banning PFAS from being used in the production process for smartphones is akin to banning mercury from being used in thermometers because it is harmful when ingested, or banning chlorine from being used in pools because it is harmful if you ingest it. 

Some bans/restrictions might very well be needed and justified but banning an entire category of evolving products won’t serve the consumer. A more appropriate response would be to evaluate these chemicals and substances based on the risk they present and how they are used, rather than lumping them all together and risk enacting bad policy that will have a myriad of consequences. 

Originally published here

Ontario set to make cannabis delivery, curbside pick-up permanent

“Through the pandemic, licensed cannabis retailers have proven that we can operate home delivery in a safe and secure manner.”

A new proposal from the Ontario government, the Supporting People and Businesses Act, would allow private cannabis retailers to offer delivery and curbside pick-up permanently.

Retailers were permitted to offer delivery and pick-up services during the pandemic and advocates have argued that the success of the temporary measures proves it’s a viable and safe option for consumers.

The decision to grant these options during the pandemic helped cannabis retailers stay afloat and limit layoffs, according to Raj Grover, the president and CEO of High Tide, a retail-focused cannabis company.

Read the full article here

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