The FDA’s decision opens a fourth dose of the Pfizer or Moderna vaccines to that age group at least four months after their previous booster.

Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.

The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans. The Centers for Disease Control and Prevention is expected to weigh in.

The move comes at a time of great uncertainty. COVID-19 cases have dropped to low levels after the winter surge of the super-contagious omicron variant. CDC data shows that two vaccine doses plus a booster still provide strong protection against severe disease and death.

But an omicron sibling is causing a worrisome jump in infections in Europe, and spreading in the U.S., even as vaccination has stalled. About two-thirds of Americans are fully vaccinated, and half of those eligible for a first booster haven’t gotten one.

Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults “to provide flexibility” for the government to decide who really needs one.

The FDA set age 50 as the threshold for both companies. As for the immune-compromised, only the Pfizer vaccine can be used in those as young as 12; Moderna’s is for adults.

There’s limited evidence to tell how much benefit another booster could offer right now. FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots.

The newest booster expansion may not be the last: Next week, the government will hold a public meeting to debate if everyone eventually needs a fourth dose, possibly in the fall, of the original vaccine or an updated shot.

December 2, 2020 – Albany, NY – Governor Andrew M. Cuomo provides a coronavirus update during a press conference in the Red Room at the State Capitol. (Mike Groll/Office of Governor Andrew M. Cuomo)

ALBANY – Governor Andrew Cuomo announced Wednesday that New York will receive 170,000 COVID-19 vaccine doses by Dec. 15.

Cuomo said that the vaccines will be distributed once they are approved by the FDA and then reviewed by a state panel. He said the 170,000 is based on the CDC reporting that a limited number of vaccinations will be distributed in each state and it will be based on the percentage of a state’s population to the overall population of the country.

That first batch of 170,000 vaccines will be those manufactured by Pfizer, Cuomo said, and another batch of a yet-unknown size is expected two weeks later from Moderna, another pharmaceutical company.

By the end of the month, 20 million people are expected to be vaccinated nationally — about 6 percent of the country’s population.

The Food and Drug Administration has a critical meeting next Thursday to authorize emergency use.

Cuomo said if approval is granted, the first doses will go to nursing home residents and health care workers.

He also said that people are skeptical of any vaccine that is rushed for approval by the FDA, which is why he’s calling on a state panel to also review any vaccine prior to being distributed in New York.

“The New York panel will review the FDA’s approval. Why? Because we know we have existing skepticism about the vaccine. Our panel did not create the skepticism. The skepticism existed and that’s why we created the review panel,” Cuomo said. “The Kaiser poll says 60 percent of Americans are skeptical about the vaccine approval process. Kaiser is not a political organization. Pew poll says about 50 percent of Americans are skeptical about the vaccine. That is very, very troubling. If people think the vaccine approval process was politicized, they’re going to be less likely to take the vaccine.”

The governor also cited experts who say the “normal economy” will return when between 75 and 85 percent of the population is vaccinated. But that process, he said, will likely take until June or September depending on the efficiency of the distribution process, which he described as the “largest governmental operation undertaken since World War II.”

The FDA has a critical meeting next Thursday to authorize emergency use.

Meanwhile, the governor is continuing to tell residents to do what they can to mitigate spread and avoid overwhelming healthcare facilities.

“The biggest fear is overwhelming the hospitals, period. That’s where we are and that is a serious, serious concern,” Cuomo said. “We know the capacity of hospitals – 54,000 statewide. We know it by region. Manage that load. Increase and balance the testing. There is a lot of demands on testing. You have to test nursing homes, you have to test essential workers, you have to test business professionals who have licenses, who have to be tested as part of their work. You want to be fair in balancing that testing.”

The governor also indicated that it is up to every resident to work to slow the spread and urged them to follow the advice of health experts and also his executive order guidelines.

“My personal opinion is that you’re going to see the increase continue all through the holidays. You’ll see it continue through January 2 and then the lag for the testing and hospitalization which takes you to about mid-January. The question is, how fast do the cases increase? Nobody can tell you because it depends on what people do. It is up to us. There is no pre-determined fate. It is a pure function of what New Yorkers do. It’s a pure function of social action,” the governor said. “What can government do during this period? We can warn people. We can educate people. We can enforce restrictions. We can do testing and tracing.”

ALBANY – The use of CBD oils has been exploding across New York and that’s leading to some health officials and lawmakers questioning how safe the product actually is for consumers.

CBD (aka cannabidiol) is an active ingredient in hemp and marijuana plants that, unlike THC (the main psychoactive compound in marijuana), doesn’t get get the user high. While it’s marketed as a health and wellness product capable of relieving anxiety, stress, pain and insomnia, CBD remains largely unregulated on both a federal and state level.

According to the Albany Times Union – the industry around CBD continues to skyrocket across the state and that has attracted unscrupulous players whose interest in making a buck overrides concern for product transparency and consumer safety.

In the last four years, the U.S. Food and Drug Administration has issued dozens of warning letters to CBD companies selling mislabeled, falsely advertised, adulterated and contaminated products.

The federal 2018 Farm Bill, enacted in December, was intended in part to clear up the legal status of CBD. But the law also created new confusion for businesses wanting to sell CBD food or drink. For some, it is impossible to follow one set of regulations without being in breach of another.

In New York, for example, officials at the state Department of Agriculture issued guidance in December saying it was legal to sell “CBD tea,” “chocolates with CBD drizzle” and other CBD edibles, so long as the products are made and marketed as dietary supplements, which are governed by more stringent standards than ordinary food.

But the department also warns that doing this will run afoul of rules issued by the FDA, which said it was unlawful to add CBD to food or to market it as a dietary supplement.

The difference between state and federal law led to  a recent crackdown in New York City, based on safety concerns regarding some CBD edibles that were being sold at local shops.

In New York, hemp farmers and processors have teamed up with lawmakers in hopes of clarifying rules around the industry.

In the meantime, some retailers are trying to get the word out to consumers about ways to stay smart and safe when trying CBD products. According to the Times-Union article, some questions consumers need to ask before purchasing the now-legal product from a business include has it been third-party tested? Does the business have proof? And can the customer see it?

Sen. Chuck Schumer

NEW YORK – U.S. Senator Charles Schumer is calling on the Food and Drug Administration (FDA) to use a law on the books to immediately ban kid-friendly e-cigarette flavors.

According to Schumer, an e-cigarette warning letter to the FDA was signed last month by a coalition that includes the American Academy of Pediatrics, American Cancer Society, American Heart Association and the American Lung Association, which cites their concerns with the kid-friendly flavors.

Schumer said the FDA should use the Tobacco Control Act, which was passed in 2009, to reign in e-cigarettes and control the marketing to adolescents.

County Health Director Christine Schuyler addresses the Chautauqua County Legislature Wednesday, March 23 to explain why the county health board is looking to increase the legal age for buying tobacco products from 18 to 21.

MAYVILLE – Chautauqua County lawmakers have decided to wait another month before acting on a local law to increase the legal age for purchasing tobacco products.

On Wednesday during the Chautauqua County Legislature’s monthly voting session, legislator Mark Tarbrake (R-Jamestown), who sponsored the local law, announced it would be tabled.

The announcement came after seven people spoke during the legislature’s public comment, with three of them representing businesses that oppose the increase, while four were from anti-tobacco organizations that were in favor of the increase.

Tarbrake said the tabling came after a number of legislators requested more time and information on the impacts of raising the legal age to purchase tobacco and nicotine products to 21, with the main concern surrounding the potential economic impact.

“There was concern from a number of legislators that they needed more information. I’ll be honest. I’m in full support of this local law,” Tarbrake said following the meeting. “I think it needs to pass in this county for the sake of our young children. It’s fine that the other legislators wanted to have more information. The people who spoke here tonight were well spoken, gave their view on both sides of the issue and I think that will help and hopefully next month we can pass this local law.”

Members of the county legislature listen to one of the seven members of the public who commented on a proposed local law to increase the legal age to purchase tobacco products.

According to the language in the proposal, the legal age for buying tobacco products would be increased from 18 to 21 for several reasons. They include a recent study that found Chautauqua County has the ninth highest smoking rates in New York State (27.8 percent) and most of the county’s residents who smoke began doing so before the age of 21.

he local law also cites an national report from the federal Food and Drug Administration, entitled “Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products,” which found that nicotine has an adverse physiological effect on brain development in adolescents, and that by raising the minimum legal age, it will likely immediately improve the health of adolescents and young adults by reducing the number of those exposed to those effects.

One of those who spoke in favor of the local law was county public health director Christine Schuyler, who said following the meeting that she was surprised the law would be tabled.

“This has been underway with the board of health since October,” Schuyler said. “I think it is important, if the legislature needs more information and needs more time to study this, that they have the time do so. I think they will make a much more informed decision that reflects the best interest of the people in the county when they have the ample time to do so. I’d rather see it tabled than have a decision made in haste that isn’t going to be good, one way or the other.”

One of the three individuals who spoke against the measure was Jamestown resident and business owner Brian Ellis, who runs Yeti Vape in the Third Street Plaza. Ellis said that by including e-cigarette products in the ban, it will prevent adults between 18 and 20 years who are already addicted to nicotine from being able to buy e-cigarette products to help quit smoking. He said that considering e-cigarettes have not been proven to be as harmful as traditional tobacco products, they shouldn’t be included in the proposed law. He also cited an economic impact on local business, with smokers in the 18 to 20 age group going to nearby Pennsylvania or Erie and Cattaraugus Counties in New York to purchase tobacco products.

Following a 15 to 1 vote to table the measure, Tarbrake said it will likely be taken up again during next month’s voting session. The local law needs at least 10 votes from the legislature before it can go to County Executive Vince Horrigan for his consideration. Horrigan would also be required to hold a public hearing on the local law prior to signing or vetoing the measure.

• READ THE FULL PROPOSED LOCAL LAW

The proposed law will be taken up by the Human Services committee when it meets Wednesday, March 16 at 5:15 p.m. on the third floor of the Gerace Office Building. It will also be introduced to the full legislature during its next voting session on March 23.

According to the language in the proposal, the legal age for buying tobacco products would be increased from 18 to 21 for several reasons. They include a recent study that found Chautauqua County has the ninth highest smoking rates in New York State (27.8 percent) and most of the county’s residents who smoke began doing so before the age of 21.

The local law also cites an national report from the federal Food and Drug Administration, entitled “Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products,” which found that nicotine has an adverse physiological effect on brain development in adolescents, and that by raising the minimum legal age, it will likely immediately improve the health of adolescents and young adults by reducing the number of those exposed to those effects.

Products that would fall under the guidelines include cigarettes, cigars, chewing tobacco, powdered tobacco, other tobacco products, nicotine water, herbal cigarettes, electronic cigarettes, liquid nicotine, snuff, rolling papers, and smoking paraphernalia.

Enforcement of the law would be similar to the rules and guidelines retailer currently have to follow in regard to selling tobacco products to anyone under the age of 18.

If approved by the legislature, the law would go into effect on Oct. 1, 2016.

Eric Schneiderman

ALBANY – State Attorney General Eric Schneiderman has joined his counterparts in Indiana and Illinois to call on federal officials to take action to prevent poisoning of children from liquid nicotine and other novel tobacco products.

In a letter Tuesday to the U.S. Food and Drug Administration, the attorneys general requested that the agency develop standards for child-resistant packaging and to put warning labels on the liquid used in e-cigarettes as well as nicotine-based dissolvables, lotions, gels and drinks.

The request comes in the midst of a surge of use in e-cigarettes, which tripled among middle school and high school students from 2013 to 2014.

The American Association of Poison Control Centers reports a recent uptick in calls resulting from exposure to e-cigarettes and liquid nicotine. There were nearly 3,800 such calls last year, up from about 1,500 the year before. Half those calls related to children under 5.

Liquid nicotine is highly toxic and must be diluted before it can be used in e-cigarettes. A single teaspoon of liquid nicotine can be lethal to a child, and smaller amounts can cause severe illness, often requiring trips to the emergency room.

A bill before the state Senate and Assembly would add e-cigarettes to the list of products covered under the state’s Clean Indoor Air Act, which bans traditional smoking in certain indoor areas.

E-cigarettes are electronic vaporizers that let users inhale nicotine and exhale plumes of vapor.

The bill, which awaits action in both houses, also appears to be aimed at curbing children’s exposure to e-cigarettes at shops that sell them. Recent studies have shown that while the use of traditional tobacco products by teens has seen a drop, the use of e-cigarettes among teenagers, has actually been on the rise.

According to the Senate bill’s memo, it would require e-cigarette retailers not registered with the state Department of Taxation and Finance — such stores currently aren’t required to have a tobacco registration — to register with the Department of Health, opening them up to compliance checks.

Critics of e-cigarettes point to studies that show short-term adverse health effects, as well as a lack of studies looking at long-term impacts. Proponents have said that the e-cigarettes are far less harmful to users than traditional tobacco products and have helped smokers quit when other options have failed.

E-cigarettes also are not regulated by the FDA, though such regulations may be outlined in the coming months.

The senator said Sunday the chemical is still used at other chains, including McDonald’s, Starbucks, Arby’s, Wendy’s, Burger King, and KFC.

Sen. Schumer said  that Subway has done it on its own and now its time for other retailers to do the same. But he said he’ll also put pressure on the FDA to ban it as well. we’re asking the FDA to ban it. The chemical is already banned in both the European Union and Australia.