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FDA Finalizes Enforcement Policy on Unauthorized Flavored E-Cigarettes That Appeal to Children - Food & Drug Administration

Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.

“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” said HHS Secretary Alex Azar. “By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary.”

“As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we’re issuing today confirms our commitment to dramatically limit children’s access to certain flavored e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools and communities,” said FDA Commissioner Stephen M. Hahn, M.D. “Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery. While we expect that responsible members of industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”

The final guidance outlining the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, comes as the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use show that more than 5 million U.S. middle and high school students are current e-cigarette users (having used within the last 30 days) – with a majority reporting cartridge-based products as their usual brand.

The NYTS survey, which is conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, also shows that of current youth e-cigarette users in 2019, approximately 1.6 million were using the product frequently (use on 20 days or more in a 30-day period), with nearly one million using e-cigarettes daily. Additional data from another federal survey further underscore that youth are particularly attracted to e-cigarette flavors such as fruit and mint, much more so than tobacco or menthol flavored e-cigarettes. These overall levels of youth e-cigarette use are particularly concerning because using e-cigarettes puts them at risk for nicotine addiction and other health consequences. In particular, evidence shows that youth exposure to nicotine can adversely affect the developing adolescent brain and that, compared with non-users, youth who use e-cigarettes are more likely to try conventional cigarettes in the future.

On Aug. 8, 2016, all e-cigarettes and other ENDS products became subject to the FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). All e-cigarettes and other ENDS products on the market at that time needed to have authorization from the FDA to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements. To date, no ENDS products have been authorized by the FDA — meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.

Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:

  • Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized when the product is used. For purposes of this policy, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS product.

By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products. In addition to data showing that cartridge-based ENDS products are most commonly used among youth, important findings from the 2019 Monitoring the Future survey focusing on youth use of JUUL indicate that youth preference for menthol- and tobacco-flavored e-cigarettes is much lower than that for mint- and fruit-flavored e-cigarettes. Because of the relatively low numbers of youth using both menthol- and tobacco-flavored, cartridge-based ENDS products, these products are not among the current enforcement priorities. However, should the FDA become aware of an increase of youth using any other flavored products (both cartridge-based or otherwise), the agency will take additional steps to address youth use of those products if necessary. 

For all other products (cartridge-based or otherwise), including menthol-, tobacco-, and non-flavored ENDS products, the FDA will also prioritize enforcement where the manufacturer fails to take adequate measures to prevent youth access. For example, the FDA will consider whether the manufacturer has implemented adequate programs to monitor retailer compliance with age-verification and sales restrictions or if it has established and enforced penalties against retailers that fail to comply with those programs. The agency also will consider whether the manufacturer uses adequate age-verification technology (or requires that retailers who sell its products use such technology) to prevent underage access to its website and to prevent underage sales through the internet. In addition, consideration will be given to whether the manufacturer limits (or requires retailers who sell its products to limit) the quantity of ENDS products that a customer may purchase within a given period of time. 

The FDA also intends to prioritize enforcement with respect to any ENDS products that are targeted to youth or likely to promote use of ENDS by youth. Examples include: products marketed with labeling and/or advertising that resemble kid-friendly foods and drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by promoting ease of concealing the product or disguising it as another product; and products marketed with characters designed to appeal to youth.

Importantly, the FDA’s enforcement priorities are not a “ban” on flavored or cartridge-based ENDS. The FDA has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. Manufacturers that wish to market any ENDS product – including flavored e-cigarettes or e-liquids – are required by law to submit an application to the FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.

The guidance also states that, after May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application. For ENDS products other than those in the three groups described above, if premarket applications are submitted by that date, the FDA intends to continue to exercise enforcement discretion for up to one year pending FDA review of the applications, unless there is a negative action by the FDA on such application or the product is authorized to be marketed by the FDA.

The FDA has demonstrated a deep commitment to taking steps to prevent youth from using and becoming addicted to any tobacco product, including e-cigarettes. This enforcement policy is an important step in the agency’s ongoing work to ensure these products are not marketed to, sold to, or used by kids, as outlined in the agency’s Youth Tobacco Prevention Plan, including investing in public education campaigns to educate youth about the dangers of e-cigarette use, provide resources to educators, parents and community leaders to prevent youth use, as well as further explore how to help those kids who are already addicted to e-cigarettes quit.




CPSC Reminds Consumers to Warm Up to Safety this Winter! - Consumer Product Safety Commission

WASHINGTON, D.C.  – The weather outside may be frightful – with snow, ice and freezing temperatures, but the U.S. Consumer Product Safety Commission (CPSC) wants to remind families to remain vigilant about safety in and around the home this winter. Here are three winter hazards to keep in mind.

First, Carbon Monoxide – The Invisible Killer
Use portable generators outside your home and place them at least 20 feet away from the residence with exhaust pointed away from spaces where it can gather and present a hazard. Never use a generator inside a home, basement, shed or garage. The exhaust from portable generators contains poisonous carbon monoxide (CO), which can kill in minutes. 

Most portable generator-related deaths from CO poisoning occur during the cold months. 

Never leave a car running in a garage, even with the garage door open.

Install CO alarms in your home on every level and outside all sleeping areas. Test CO alarms monthly. 
See our new video here. 
 
Second, Space Heaters – Give Them Space

Your space heater needs space. Keep flammable objects, such as curtains, sofas, beds, clothes and papers at least 3 feet away from your space heater at all times.

Make sure your space heater is placed on a stable, level, flat surface in an area where it can’t be knocked over.

Turn off space heaters when you are sleeping, or when you leave the room. 

Install smoke alarms on every floor of your home, outside all sleeping areas, and inside each bedroom. Test smoke alarms once a month to make sure they are working.
 
Third, Snow Blower Hazards – Clear Snow Safely 

Most snow blower injuries happen when consumers try to clear snow from the discharge chute with their hands.

NEVER leave a gas-powered snow blower running in an enclosed area. The exhaust contains poisonous carbon monoxide, which can kill in minutes.

Don’t add gasoline to a running or hot engine, to avoid a fire; and always keep the gasoline in a portable gasoline container with a child-resistant closure to prevent child poisonings.




FTC Issues Biennial Report to Congress on the National Do Not Call Registry - Federal Trade Commission

The Federal Trade Commission has issued its biennial report to Congress focusing on the use of the National Do Not Call (DNC) Registry by both consumers and businesses and other organizations over the past two years. 

This year’s report includes: 1) a summary of current Registry operations; 2) a summary of the impact on the Registry of new telecommunication technologies; and 3) a discussion of the impact of the established business relationship exception in the Commission’s enforcement efforts.

The DNC Registry currently has more than 239 million active registrations, an increase of more than 4.1 million registrations from the previous fiscal year (FY). According to the report, during fiscal year 2019, 2,014 businesses and other entities paid more than $12 million to access the Registry. More than 15,000 entities subscribed to access the Registry, including those who registered for five or fewer area codes free of charge, and 541entities (such as charitable organizations) claimed “exempt organization” status and also received free access to the Registry. 

In FY 2018, 2,163 entities paid Registry access fees totaling nearly $12.3 million. That year, 15,045 entities subscribed to Registry, including those who registered to access five or fewer area codes at no charge, and 520 entities claimed “exempt organization” status and accessed the Registry without paying a fee.

The report concludes that the DNC Registry exists to provide consumers with a choice regarding whether or not to receive telemarketing calls. Accordingly, the FTC and FCC work to keep it accessible and effective for both consumers and telemarketers. As new technology provides new challenges, the FTC actively seeks to address and confront them by, among other things, encouraging private industry, other government agencies, academia, and other interested parties to create and develop new strategies to help consumers avoid unwanted telemarketing calls.

The Commission also publishes an Annual Do Not Call Registry Data Book that provides substantial detail on registration numbers and other statistical information about the Registry. Similar information is also available our Tableau public page, which is update quarterly and allows users to interact with the data to drill down to state or county data.

The Commission vote authorizing the biennial report to Congress was 5-0. (The staff contact is Ami Dziekan, Bureau of Consumer Protection, 202-326-2648) 



 Is It a Cold or the Flu? Prevention, Symptoms, Treatments - U.S. Food & Drug Administration

Most viral respiratory infections, like the common cold, usually come and go within a few days, with no lasting effects. But influenza (flu) is a disease that can cause serious health problems and can result in hospitalization or death.

You can fight back by adopting healthy habits and by using medicines and vaccines approved by the U.S. Food and Drug Administration to combat and help prevent the flu.

If you are generally healthy, here’s how to tell if you have a cold or the flu, and when to seek medical care.

Symptoms of Colds and Flu

Flu and cold viruses spread mainly by droplets, when infected people cough, sneeze, or talk. You also can get infected by touching a surface or object that has flu viruses on it, such as a door handle, and then touching your eyes, nose, or mouth. Flu season in the United States may begin as early as October and can last as late as May, and generally peaks between December and February.

Colds: Symptoms of colds usually are a stuffy or runny nose and sneezing. Other symptoms include coughing, a scratchy throat, and watery eyes. There is no vaccine to prevent colds, which come on gradually and often spread through everyday contact.

Flu: Symptoms of the flu come on suddenly and can include fever, headache, chills, dry cough, sore throat, body or muscle aches, tiredness, and feeling generally miserable. Like the viruses that cause a cold, flu viruses can cause a stuffy or runny nose, sneezing, and watery eyes. Young children also may experience nausea and vomiting.

Check with your health care provider promptly if you are at high risk for flu-related complications and you have flu symptoms — or if you have flu symptoms that do not improve. People at high risk include:

  • Children younger than 5 years, but especially those younger than age 2
  • Pregnant women
  • People with certain chronic health conditions (such as asthma, diabetes, or heart or lung disease)
  • People age 65 or older

Rapid Flu Tests Are Available

Some health care providers can give you an FDA-cleared rapid flu test. There are 17 rapid flu tests (11 antigen-based and six molecular-based) on the market with updated performance criteria that the FDA created to provide reasonable assurance that the test is accurate, reliable, and clinically valid.

According to the Centers for Disease Control and Prevention’s flu testing guidelines, you don’t need testing — or to await test results — before your health care provider can prescribe antiviral medication. Your health care provider will decide what to prescribe based on the signs and symptoms you have.

What to Do if You’re Already Sick

Colds usually run their course. When you’re sick, limit exposing yourself to other people. Cover your mouth and nose when you cough or sneeze. Also, stay hydrated and rested. Avoid alcohol and caffeinated products.

There are FDA-approved prescription medications — called antivirals — for treating flu. Also, a cold or flu may lead to a bacterial infection (such as bronchitis, sinusitis, ear infections, and pneumonia) that could require antibiotics.

Most people with the flu who aren't at high risk have mild illness and do not need medical care or antiviral drugs. Still, your symptoms may last up to two weeks.

How to Safely Take Nonprescription Medicines for Cold or Flu Symptoms

Read medicine labels carefully and follow the directions. People with certain health conditions, such as high blood pressure or diabetes, should check with a doctor or pharmacist before taking a new cough or cold medicine.

  • Choose the right over-the-counter (OTC, or non-prescription) medicines for your symptoms.
  • Nasal decongestants help unclog a stuffy nose.
  • Cough suppressants help relieve coughs.
  • Expectorants help loosen mucus.
  • Antihistamines help stop a runny nose and sneezing.
  • Pain relievers can help ease fever, headaches, and minor aches.

Check the medicine’s side effects. Medications can cause drowsiness and interact with food, alcohol, dietary supplements, and other medicines. Tell your doctor and pharmacist about every medical product and supplement you are taking.

Check with a health care professional before giving medicine to children.

How to Avoid Getting Sick

Get vaccinated against the flu. The best way to prevent the flu is by getting vaccinated every year. The vaccine changes each year and contains flu virus strains that are expected to be prevalent during the upcoming flu season. The protection from the previous year’s vaccine will diminish over time and may be too low to protect you into the next year, even if the flu virus strains circulating the next year are the same as those contained in the previous year’s vaccine.

With rare exceptions, the CDC recommends that everyone ages 6 months and older should be vaccinated against flu. The flu vaccine provides protection from the flu and its potential complications, which can result in hospitalization and sometimes death.

Annual vaccination is especially important for people at high risk for developing serious complications from flu: health care workers, and anyone who lives with or cares for people at high risk for serious flu-related complications.

Although children younger than 6 months are too young to be vaccinated, they have the highest risk for being hospitalized because of flu and flu-related complications compared to children of other ages. Therefore, the CDC recommends that parents, grandparents, caregivers, and all household members 6 months or older should be vaccinated because they will be less likely to get the flu and spread it to the unvaccinated child. If possible, keep infants away from crowds for the first few months of life.

Wash your hands often. Teach children to do the same. Both colds and flu can be passed through contaminated surfaces, including the hands. Wash hands with warm water and soap for at least 20 seconds. Try not to touch your eyes, nose, or mouth. Clean and disinfect frequently touched surfaces, especially when someone is ill.

Limit exposure to infected people. Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
 
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