Retail Sales of Tobacco Products - FDA.gov

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Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note:
On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

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Landmark Marijuana Legislation Moves through Congress - JDSUPRA

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Read the full article:   Landmark Marijuana Legislation Moves through Congress - JDSUPRA

According to the article:

"On November 20, 2019, the House Judiciary Committee passed the Marijuana Opportunity Reinvestment and Expungement (MORE) Act of 2019. The historic bill was sponsored by House Judiciary Chairman Jerrold Nadler (D-NY) and can now move to a floor vote in the House of Representatives."

Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com

Read the full article: Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com:

"The governor of California has signed a contentious bill to impose one of the strictest school vaccination laws in the country.

Democratic Gov. Jerry Brown says in a statement Tuesday that science clearly shows vaccines dramatically protect children against infectious diseases."

'via Blog this'

#FDA #GMP #training #cGMP

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Entertaining Healthcare Reform Animated Video Primer

This is really great stuff.  I have no patience to digest pages and pages of healthcare reform legislation.  This fun and informative animation makes it all very entertaining and digestible.



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Drug Safety and Accountability Act of 2010

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Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Bennet's press release, Senate Introduces New Bill on Drug-Manufacturing Quality Standards, says:

The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.

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Dietary Supplements - Legislation Introduced - S. 3414

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New dietary supplement legislation (S. 3414) has been introduced by Senators Harkin and Hatch, as reported by this Lexology article, Dietary supplements on the Hill - new legislation introduced.

In a nutshell:

1. It would allocate funds to the FDA to implement and enforce DSHEA.
2. It would require the FDA to make annual reports to Congress on its implementation and enforcement of DSHEA.
3. 180 days after the enactment of S. 3414, the FDA would be required to publish a guidance document on New Dietary Ingredients (“NDI”).

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World No Tobacco Day is May 31st

If you're a smoker, consider trying to stop smoking on World No Tobacco Day.

On the 31st of May each year, WHO celebrates World No Tobacco Day, highlighting the health risks associated with tobacco use and advocating for effective policies to reduce consumption. Tobacco use is the second cause of death globally (after hypertension) and is currently responsible for killing one in 10 adults worldwide.

The theme of World No Tobacco Day 2010 is "Gender and Tobacco" with an emphasis on marketing to women. The campaign focuses on the damaging effects of tobacco marketing towards women and girls.

The World Health Organization (WHO) urges governments and the public:

1. to demand a ban on all forms of tobacco advertising, promotion and sponsorship
2. to support implementation and strong enforcement of legislation to provide 100% protection from tobacco smoke in all public and work places, and
3. to take global action to advocate for women's freedom from tobacco.

The World No Tobacco Website
 
Previous Posts:
Tobacco Products - Big Pharma Takes On Big Tobacco
FDA Restricts Cigarette and Tobacco Sales and Distribution
Tobacco Will Kill Millions Next Year
FDA Launches New Tobacco Products Center
 
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Biosimilars In Recently Passed Healthcare Bill

I was really surprised to find out that biosimilars are included in the recently passed healthcare bill, Patient Protection and Affordable Care Act.  I learned about this while reading Kevin O'Donnell's post on his blog (Where cooler heads prevail), "New U.S. Healthcare Bill Includes Pathway for Biosimilars and 12 Year Patent Exclusivity."

Kevin writes:

"This provision, Title VII- Providing Access to Innovative Medical Therapies, "prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date on which the reference product is first approved. In addition, it stipulates an additional 6 months of exclusivity for the use of reference products "in the pediatric population.""

References:
Full text of the Patient Protection and Affordable Care Act HR 3590

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Fire Safe Cigarettes Are A Good Thing

I've not heard about fire-safe cigarettes until now, after reading this MSNBC News article, Smokers burned up over ‘fire-safe cigarettes’ - Self-extinguishing smokes sweep the country, but many say they taste bad. As a non-smoker, I think they're a good idea. Living in a parched, drought-stricken location, I see far too many lit cigarettes tossed on the ground, posing a potential fire danger. I can also see the benefit to those choosing to smoke in bed, or prone to falling asleep while smoking. I can see why it'll be hard for remaining states to resist the tide to enact fire-safe cigarette laws. Additional Resources: Coalition for Fire-Safe Cigarettes Petition to repeal fire-safe cigarette laws 

Related Posts: 3rd Hand Tobacco Smoke - A Danger To Your Loved Ones FDA Authority Over Tobacco - desperately needed Menthol in Cigarettes - Cig makers might've played you! (video) 

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CA Gov Delays e-Pedigree Mandate to 2015

Here's the latest update on the CA e-Pedigree situation, as reported in this The MQN Weekly Bulletin news brief, "Schwarzenegger Terminates 2009 ePedigree Deadline." Here are the main points . . .

• Under the new law, a manufacturer must have an epedigree by 2015 for 50 percent of its drugs sold in California. Unit volumes, SKUs or drug product families may define the 50 percent figure.
• California Gov. Arnold Schwarzenegger has signed legislation that delays the state’s 2009 electronic pedigree mandate for prescription drugs until 2015.

Previous Posts: The Health, Drug, Prescription, and GMP Supersite: CA E-Pedigree - Pedigree and Serialization

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FDA Authority Over Tobacco - desperately needed

I was watching this interesting Fox News video, "Tobacco Time," about the effects of smoking on aging. I typically expect to hear how smoking shortens your life. However, this video has a twist, and cites recent National Cancer Institute research, reporting that smoking ages your body 10 years beyond your chronological age.

In any event, while googling for more smoking information, I stumbled across the topic about efforts to put tobacco products under the authority of the FDA. My reading started with this Campaign for Tobacco-Free Kids Special Report, "FDA Authority Over Tobacco - Legislation Will Protect Kids and Save Lives." It frames the issue well, and explains the legislative context. This article has been recently updated, reporting successful passage of legislation in the House, "U.S. House Casts Historic Vote to Protect Kids from Tobacco, Save Lives; Senate Should Act This Year and President Should Sign Bill Into Law." It reports, "this legislation would grant the FDA strong and effective authority over the manufacturing, marketing and sale of tobacco products."

Related to Tobacco Products:

1. The Easy Way to Stop Smoking: Join the Millions Who Have Become Non-Smokers Using Allen Carr's Easyway Method
2. Nicorette Gum

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