FDA plans first public hearings on legalizing CBD foods in April - CNBC

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Read the full article:  FDA plans first public hearings on legalizing CBD foods in April - CNBC

"The Food and Drug Administration will hold its first public hearings on CBD in April as the agency weighs rules allowing companies to add the popular cannabis-based compound to food, Commissioner Scott Gottlieb said Wednesday. 

"We're deeply focused on this. We have taken on other hard challenges before," Gottlieb told the House Appropriations Committee on Wednesday. "You have my commitment I'm focused on this one.""

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FDA Drug Quality and Security Act Stakeholder Discussion Notes - No Bullwhip

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Updated October 24, 2022

The original link broke.

You can still read about the same topic here:

Drug Quality and Security Act - What You Need to Know - McGuireWoods.com

---  the original post follows below  ---

FDA Drug Quality and Security Act Stakeholder Discussion Notes - No Bullwhip:

"The FDA held its first public stakeholder call this morning (Dec. 3rd, 2013) to discuss the new Drug Quality and Security Act law. This is the first of a series of public engagements that the FDA will hold as the various provisions of DQSA are phased in starting Jan. 1, 2015 and continuing over the next 10 years.

The call, led by Dr. Ilisa Bernstein and Cara Tenenbaum of the FDA, didn't contain much in the way of hard specifics on rules, regulations and licensure. The FDA is still developing its go-forward plans and communication processes."

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Growing Anger Against The Pharmaceutical Industry

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We The People vs. The Pharmaceutical Industry - Forbes:

". . . All this adds up to a giant pushback against the astronomical drug prices that are becoming commonplace. It seems that price tags of $100,000 or above are becoming the norm. Of 12 cancer drugs approved in 2012, 11 cost more than that. As more drugs are offered at that level and their sponsors get away with it, it seems to set a floor that emboldens drug companies to push the envelope. They are badly misjudging the brewing anger. . . ."

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FDA rethinking food inspections

I wonder what Upton Sinclair would say about the state of current affairs.

FDA rethinking food inspections - DailyHerald.com:

"The surge in imports has also increased the chances of contamination in foods regulated by the FDA. About 80 percent of seafood, 50 percent of fresh fruits and 20 percent of fresh vegetables are imported.

Despite the mounting threats, the FDA and its contractors inspected only 6 percent of the 421,000 domestic and foreign facilities under its watch in 2010, according to the most recent figures. Inspections account for the full-time work of just 1,000 employees. But if a site is linked to an outbreak of illness, inspectors and FDA scientists descend on it, sometimes staying put for weeks.

Under the food-safety bill enacted last year, food companies must adopt plans to spot and prevent hazards. The law also mandates more frequent inspections. For instance, plants that produce or process high-risk foods, including foods connected to previous outbreaks, must be inspected by 2015 and every three years thereafter."

'via Blog this'

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Related articles

• Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA (drughealth.blogspot.com)
• FDA Audit Preparation (drughealth.blogspot.com)

FDA Inspection Classification Database Search - Free

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FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

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Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com ('via Blog this')

A good read on the shaky tension between legitimate, tainted, and dangerous supplements. The supplement industry blames the FDA for failing to institute mandatory recalls and seize tainted goods.

In a nutshell:

Daniel Fabricant of the FDA says, "the growing availability of tainted products represents a serious public health problem, one that could taint the dietary supplement industry as a whole."

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Say No To Drugs PSAs - Public Svc Announcements over the yrs

Updated April 21, 2017
This post didn't age well. The video links have broken, so I've removed them from the original post. You can get a sense of the video with this collection of photos:
PSAs Say No to Drugs

- -  most of the original post follows below  - -

I was catching up with news this wet Saturday morning and ran across this CBS News mini-history of anti-drug messaging over the years. Enjoy!

For related photos and links specific to this video clip go to CBS News PSAs Say No to Drugs Photos.

Previous Posts:
Sugar As Addictive As Cocaine Or Heroin
Epidemic Teen Addiction To Prescription Drugs (video)
Parents, Get A Clue About Teen Drug and Alcohol Abuse
Are Your Teens Abusing Drugs? - 4 Tips

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Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

• Agenda (PDF - 64KB)
• Registration form (PDF - 20KB)

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

Return Home: http://drughealth.blogspot.com/ 

FDA Wants Your Input On Tobacco Regulation

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Updated March 2, 2020

The links in the original post broke.

You might also be interested in:
Tobacco Products - Rules, Regulations, and Guidance (on FDA.gov)

- - -  the original post follows below  - - -

The U.S. Food and Drug Administration (FDA) announced that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. If you feel strongly about tobacco as I do, I hope you'll submit some feedback to the FDA.

More References:
The Federal Register Notice
FDA and Tobacco Regulation

Related Posts:
NPR On FDA Tobacco Oversight (audio)
Smoking Is Too Expensive - It is time to quit
e-Cigarettes In The News (video)
Fire Safe Cigarettes Are A Good Thing
3rd Hand Tobacco Smoke - A Danger To Your Loved Ones

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Are Nanoparticles Dangerous Like Asbestos?

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Updated October 15, 2022:

You might also be interested in:

GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

---  the original post follows well below  ---

Updated January 9, 2021

Speaking of nanoparticles, you might also be interested in:

Fact check: Lipid nanoparticles in a COVID-19 vaccine are there to transport RNA molecules - Reuters

- - -  original post follows below  - - -

More recent news buzz on the topic recently. When I see nanotechnology, or nanoparticles, I'm worrying about whether we're creating a wave of manmade asbestos-like materials and ensuing mesothelioma. I stumbled across this on the NIOSH site, and think you'll find it an interesting read. Coming from NIOSH, I'm more likely to believe what I read, "Approaches to Safe Nanotechnology - Managing the Health and Safety Concerns Associated with Engineered Nanomaterials." The document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. This updated version of the document incorporates some of the latest results of NIOSH research, but it is only a starting point. The document serves a dual purpose: it is a summary of NIOSH's current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops. 

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Bad Economy Improves Public Health!?

Yeah, it's counterintuitive, as reported in this LA Times news article, "Can a troubled economy actually improve public health? " It's an interesting thought, a poor economy might actually help all of us cut down on risky behaviors, and lead to a potentially healthier population.

I would've imagined that a recession would make us all go out, get stressed, smoke more, and drink harder, etc. But to my surprise, here's what seems to really happen . . .

1. Traffic accidents go down when fewer people are working
2. People drink less. That is to say, people who already drink, do less of it.
3. Healthful living improves.

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It Is August 2008 - Upcoming GMP Public Seminars

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2008 is starting to come to an end. Be sure to send your key personnel to training this year. Here's what I came up with while searching for some GMP-related public seminars during the remainder of the year . . .

1. SkillsPlus International Inc. - Public Seminars

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