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FDA Regulation Of Tobacco: What Does It Mean?

On Friday 12th June, the US Senate voted in favor of a bill that gives the Food and Drug Administration the power to regulate tobacco products. President Obama (who as a Senator was a sponsor of the bill, as was John McCain) has indicated he will sign the bill into law.

Public health advocates have been fighting for FDA regulation of tobacco for over 15 years. However, not every public health advocate has supported this particular piece of legislation, and the fact that Philip Morris Tobacco Company supported it caused many to have doubts. But now that the bill is finally going to be law, what will it mean? As a guide to this, I’d recommend that you read the slides from a paper by Mitch Zeller at the recent Virginia Youth Tobacco Conference. Much of this post is adapted from his slides. These outline the key parts of the bill and what they mean in some detail and are worth a careful read, (Mitch Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration). Download his slides here.
The bill does not require FDA to regulate tobacco exactly the same way it does pharmaceuticals (drugs and devices), partly because it would be impossible for any tobacco product to demonstrate that it is safe and effective for its purpose. So instead the legislation creates a new, parallel set of rules and procedures just for tobacco, but using much of the same regulatory framework that was created for drugs. The new standard around which the tobacco bill is based is THE PROTECTION OF PUBLIC HEALTH.

-Section 904 mandates that FDA will receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful

– Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.

– FDA also has the right to request any such industry document produced prior to the enactment of this law.

– FDA can issue performance standards to prohibit or limit the allowable levels of substances in a finished tobacco product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.

– Nicotine cannot be banned but it can be reduced to very low levels.

– FDA needs to have supporting science to back up any standards it requires, or any ingredients it wants banned.

Clearly the tobacco product standards are going to be a key part of regulation of tobacco. Here’s what the bill says on these: Read more »

This post, FDA Regulation Of Tobacco: What Does It Mean?, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

Talking to Teens About Alcohol

Last weekend an intoxicated 16-year old Orinda teen died in a hallway during a party, a preventable loss that disturbs any sane person. It makes me obsess about why our culture encourages the use of alcohol as part of celebrating and socializing, where the adults were, why the other teens ignored a person who had obviously drank too much, and most importantly, what if someone had just called 911 earlier?

Everyone in that community and all of us who heard about this tragedy will live with the “what ifs” but I hope it encourages every parent to make sure s/he has talked to their teen about expectations for their behavior, sure, but also about what to do when things get out of hand! You can help them avoid living with the “what ifs” by checking out Doc Gurley’s great article for SF Gate this week that includes six practical tips that all teens should know about alcohol!

In addition to knowing how to recognize a medical emergency which you can find in Doc Gurley’s article, families also need (rules) agreements about what to do if a teen finds themselves in a situation where alcohol is being abused. Of course, parents have to be comfortable with the agreement, but some families have agreements that include:

  • no driving a car after consuming any amount of alcohol;
  • no being in a car with anyone who has consumed any amount of alcohol;
  • not staying at a party where anyone is drinking or has had too much to drink;
  • a parent can be called at any time of the day or night to:
  • intervene at a party;
  • pick up a teen who has been drinking;
  • take a friend home who has been drinking;
  • help talk to irate parents; and
  • talk to friends about alcohol use.

Most of these agreements include a “no consequence” clause for the teen – which means there is no anger, grounding, punishment, etc… associated with any of those activities. That does not mean there isn’t a serious conversation about alcohol use that may follow a good night’s sleep, shower, and 12-hour cool down period, but if your teen does drink, you really do not want them to drive, be in a car, or be a victim in any way – so, please make sure they know that you would rather them call you and be safe!

If you want to know what your teen knows about alcohol use and when to call for help, ask him or her to tell you exactly what they would do if someone at a party has passed out or puked on themselves. If it does not including calling 911 and you to pick them up, ask them why, and then make an agreement about what will happen in those situations – and then abide by the agreement!

Every teen deserves this conversation!

This post, Talking to Teens About Alcohol, was originally published on Healthine.com by Nancy Brown, Ph.D..

Tips To Help You Quit Smoking

Patients I’ve seen who succeeded in quitting, sometimes tell me what it was that enabled them to quit this time when they had been unsuccessful many times before. Sometimes it was a change in personal circumstances, sometimes an aspect of the treatment we gave them, but sometimes they tell me there was a single thought, tip or piece of information that stuck in their mind and really helped.

So I thought I’d share a few of those thoughts or tips that helped others, and ask readers to share the things that helped them most. Here are a few:

1. “Move a muscle, change a thought”

This phrase stuck on one patient’s head as a reminder that when he was sitting and bored and starting to crave a smoke, he should get up, and get busy to help shake the thought of a cigarette from his mind.

2. “My cigarettes are radioactive”

The information that cigarette smoke contains radioactive chemicals like polonium-210 really stuck in the mind of one ex-smoker and helped her stay off them.It is estimated that smokers of 1.5 packs of cigarettes a day are exposed to as much radiation as they would receive from 300 chest X-rays a year.

In case you don’t mind polonium, here are some other substances found in cigarette smoke:

Ammonia: Household cleaner
Arsenic: Used as a poison
Benzene: Used in making dyes
Butane: Gas; used in lighter fluid
Cadmium: Used in car batteries
Cyanide: Deadly poison
Lead: Poisonous in high doses
Formaldehyde: Used to preserve dead specimens

3. “Get rid of ALL tobacco and lighters from the house and car”

Many smokers have told me that this was the single most important piece of advice they followed. They said that many times the cravings were so strong that if they had cigarettes in the house they would have smoked them. But having very thoroughly cleared them out of the house gave them some peace of mind and bought them enough time to deal with the cravings when they occurred.

I’d be interested to hear from readers what their most helpful tip or piece of information was when quitting smoking. Feel free to use the comment section to post your favorites.

This post, Tips To Help You Quit Smoking, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

Alcohol At The Beach

In continuing with the theme of getting ready for the beach and water sports this summer, let’s consider what to do about substance abuse. There is no controversy whatsoever about the fact that persons under the influence of alcohol or any other mind-altering substance have a higher incidence of accidents. In fact, ingestion of alcohol figures prominently as a statistic in falls, drownings, motor vehicle accidents and virtually every variety of activity that has ever been studied. The issue, then, is not whether or not alcohol contributes to illness and injury, but to what extent we are able to control its use by reason and, when necessary, prohibition.

Im June of 2008, Solana Beach, California banned alcohol consumption on its beaches for at least a year. This ban continues. Here is what appears on the city’s website:

Alcoholic Beverages – Alcohol is banned at all beach areas in Solana Beach. Alcohol is also prohibited in the parking lot, community center, viewpoint or any other public place adjacent to the beach. Glass is prohibited as well.

There are similar rules at, among others, Torrey Pines State Beach, Cardiff, San Elijo, South Carlsbad and Carlsbad state beaches.

City officials made this move proactively, to avoid the sorts of tragedies and social problems that have intermittently plagued “wet” beaches. Recognizing that judgment is often an irrelevant factor when it comes to drinking alcohol, they made a strong and, in my opinion, laudable move. Like it or not, judgment is impaired by drinking alcohol, so the concept of “responsible drinking” is an oxymoron when water sports and potentially hazardous surf conditions coexist with beer, wine, and liquor. Of course, the same is true for certain prescription drugs and illicit drugs.

Needless to say, civil libertarians and numerous other individuals are opposed to mandated prohibitions. They cite lack of observation of problems, principles of freedom and personal rights, and even the loss of romanticism. The issue obviously has two sides.

From a safety perspective, it’s a no-brainer. There’s no benefit to drinking alcohol and entering the ocean. It can never make you safer, and can only make you less safe. Even if you are able to drink alcohol at the beach and safely dispose of your metal cans and glass bottles, not litter, not be rowdy or obnoxious, and keep your drinking to yourself, the moment you dip a toe, you are a greater risk to yourself and to the lifeguards and other rescuers entrusted to protect you. You may not believe that to be the case, but the stories and statistics don’t support you. Having pulled intoxicated victims from the water, treated them at the scene, stitched their heads and set their broken bones in the emergency department, and having had to tell their families and friends that they are dead (while knowing that none of this would have ever happened had the victims been sober), I am offering well-intentioned advice. Not every city will mandate that you leave your beer cooler at home when you head to the beach. When you need to be the one to decide, choose wisely.

Preview the Annual Meeting of the Wilderness Medical Society, which will be held in Snowmass, Colorado July 24-29, 2009.

Join me from January 24 to February 2, 2010 for an exciting dive and wilderness medicine CME adventure aboard the Nautilus Explorer to Socorro Island, Mexico to benefit the Wilderness Medical Society.

photo courtesy of www.aquaticsafetygroup.com

*This post, Alcohol At The Beach, was originally published on Healthline.com by Paul S. Auerbach, MD, MS.*

Overheard At Pain Management Clinic

Doctor: Mr. Smith, your urine test is positive for cocaine.

Mr. Smith: [Blank Stare]

Doctor: Have you been snorting cocaine recently?

Mr. Smith: No.

Doctor: Then why is there cocaine in your urine?

Mr. Smith: Maybe your nurse put it in there.

Doctor: If my nurse had cocaine, I don’t think she’d put it in your urine.

***

Bonus tip for pain management specialists: cocaine’s half-life in the urine is 2-4 days. “Random” urine drug testing on Mondays offers a higher yield than other days of the business week because most patients abuse illicit drugs on weekends>>weekdays.

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