Now is the Time To Act! I am Serious! **updated**

[Bill Godshall]

Here are several news stories I helped generate about Senate Democrats falsely accusing Reynolds of target marketing their new smokefree spitfree tobacco products to minors during last week's HELP Cmte markup session. The WSJ article is objective, while the Dayton Daily News article quotes more harm reduction opponents (who say similar the same about e-cigarettes) repeating these false claims.

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U.S. senators attack Reynolds' alternative
They propose amendment to FDA tobacco bill to ban dissolvable smokeless products

By Richard Craver
Winston-Salem Journal
May 26, 2009
U.S. senators attack Reynolds' alternative

Two U.S. senators are aiming to snuff out dissolvable smokeless-tobacco products before they can get a toehold in the U.S. market.

Their amendment to the proposed FDA regulation bill from Sen. Ted Kennedy, D-Mass., is stoking the debate regarding the viability and possible less-hazardous role of smokeless tobacco products.

U.S. Sens. Jeff Merkley, D-Ore., and Sherrod Brown, D-Ohio, have labeled as "tobacco candy" the three dissolvable products being test marketed by R.J. Reynolds Tobacco Co.

The senators say that the dissolvable products are aimed at getting youths hooked on tobacco and nicotine. They said that some of the products are sold in containers "designed to resemble cell phones."

"There is no doubt that smokeless tobacco products are aimed squarely at children," Brown said. "We have a responsibility to protect children from suggestive marketing and dangerous products."

Reynolds counters that the products -- a pellet (Camel Orbs), a twisted stick the size of a toothpick (Camel Sticks) and a filmlike strip for the tongue (Camel Strips) -- are aimed at adult consumers who want to use a tobacco product in places where they can no longer smoke by federal and state law.

Reynolds is plowing ahead with its smokeless-tobacco initiatives as part of what Susan Ivey, its chairwoman and chief executive, calls its transformation into becoming a "total tobacco company." The company is considered the industry leader in next-generation smokeless products.

In October, Reynolds introduced the dissolvable products in test markets in Columbus, Ohio, Indianapolis and Portland, Ore. The products are made of finely milled tobacco and come in flavor styles called "fresh" and "mellow." They last from two to three minutes for the strips, 10 to 15 minutes for the orbs and 20 to 30 minutes for the sticks.

The senators' amendment was approved last week by a 15-8 vote, mostly along party lines, in the Senate committee on Health, Education, Labor and Pension. Both North Carolina senators, Republican Richard Burr and Democrat Kay Hagan, voted against the amendment.

The Kennedy bill is expected to be dealt with in the Senate next week. Like the House version of the bill that was passed in April, it would impose restrictions on the marketing of cigarettes, cigars and smokeless tobacco and allow the FDA to regulate the content of cigarettes.

In March, Burr and Hagan introduced an alternative tobacco-regulation bill that has made little progress. Their bill would create a new federal agency within the U.S. Department of Health and Human Services to solely regulate tobacco instead of assigning the task to the FDA.

Burr and Hagan said that the massive recall of tainted peanut products and other problems at the FDA demonstrate that the agency is too "overburdened" to oversee such an important component of North Carolina's economy as tobacco. Burr has threatened to filibuster the Kennedy bill.

By introducing the amendment, the senators may be providing the means for scientifically proving whether smokeless products are less hazardous than cigarettes.

Such a definitive test in the United States, which would be under the auspices of the Tobacco Products Scientific Advisory committee, has been requested for years by advocates on both sides of the issue. A report would be presented within two years to the FDA if it is given oversight of the industry.

Julie Edwards, a spokeswoman for Merkley, said that unlike nicotine gum, which is meant to be used for a limited time with decreasing use of nicotine, "tobacco candy is meant to start or continue the addiction and may have even higher doses of nicotine than cigarettes."

"We are talking about a product that hasn't been strenuously studied but is assumed to carry many of the same risks as chewing tobacco -- including the risk of cancer."

Both Reynolds officials and some smokeless-tobacco advocates dispute Edwards' statement on higher doses of nicotine in smokeless products.

Tommy Payne, the executive vice president of public affairs for Reynolds, said that the senators' amendment is part of an "abstinence-only strategy that only provides three options for smokers -- cigarettes, nicotine replacement or quitting cold turkey."

"Our smokeless products are part of a strategy aimed at harm reduction that is backed by scientists and elements of the antismoking advocacy groups," Payne said.

"Their intent with the dissolvable study could be beneficial to our efforts if the science reveals what we believe it will."

Bill Godshall, the executive director of SmokeFree Pennsylvania, said that "many inaccurate and misleading claims were made about the least hazardous tobacco products" by senators and others at the markup session. He is an advocate of switching smokers to smokeless products for health benefits.

He said that efforts to diminish or snuff out the impact of smokeless products would keep those unable or unwilling to quit cigarettes hooked on their habit.

"The amendment's real intent was to poison and pre-empt passage of, and any objective discussion about, responsible tobacco harm-reduction amendments that can significantly reduce cigarette consumption and save the lives of millions of smokers," Godshall said.

"By repeatedly referring to Camel Orbs as candy, and by falsely accusing Reynolds of target marketing them to youth -- which if true, would be actionable violations of both the Master Settlement Agreement and state minimum-age sales laws -- the senators went over-the-top to protect Marlboro's lethal cigarette empire from harm-reduction market competition by Reynolds' far less hazardous smoke-free alternatives."

Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.

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Tobacco foes say new product a lure for minors
Maker of Camel Orbs says smokeless, dissolvable tobacco is hardly candy.

By Jessica Wehrman
Dayton Daily News
Sunday, May 24, 2009 9:34 PM
Tobacco foes say new product a lure for minors

WASHINGTON - Shelly Kiser of the American Lung Association in Ohio was all set to give a presentation on Camel Orbs - a dissolvable tobacco product slightly bigger than an Altoid mint - to the Ohio School Nurses Association. All she needed was a prop.

So Kiser, director of advocacy for her organization and no great fan of Camel Orbs, headed into a Columbus gas station earlier this year and asked for a container of Orbs.

They gave it to her for free.

For smokers long confined to standing outside in crummy weather to get their nicotine fix, Camel Orbs is an alternative that keeps users out of the elements.

For Sen. Sherrod Brown and public health advocates, its yet another diabolical strategy to get kids hooked on smoking.

Brown, D-Ohio, this week successfully added a measure calling for a quick Federal Drug Administration study of Orbs and other dissolvable tobacco products to a larger bill that would, for the first time, put tobacco products under FDA regulatory authority. The bill, with the amendment, passed the committee last week and now awaits full U.S. Senate approval. It passed the House in April.

Brown compares Orbs to candy, and said the fact that the products can be passed off as breath mints is another way to lure kids into becoming tobacco addicts at a young age.

"It is criminal to me that they market to children the way they do," he said.

But David Howard, a spokesman for R.J. Reynolds, said the product, like all tobacco products, is legal only for adults over the age of 18. The product is currently not available in the Dayton area.

R.J. Reynolds introduced Orbs in Columbus, Indianapolis and Portland, Ore., earlier this year, and the company said early feedback has been positive. Orbs, he said, "meet the societal expectation of no second-hand smoke, no spitting, and in the case of dissolvables, no litter."

He said theyre hardly candy. They are made of finely milled tobacco, and designed for adults.

"The bottom line is these are tobacco products," he said. "They are clearly marked as tobacco products, they are marketed as tobacco products and they carry the same warnings as tobacco products."

He said similar products - Ariva and Stonewall - have been on the market since earlier this decade with little protest.

Still, he said he welcomes Browns amendment and any study of their product.

Bill Godshall of a group called SmokeFree Pennsylvania counts himself as one of the defenders of Orbs. He compares the products to Nicorette or Commit Lozenges and cites studies indicating they are safer than cigarettes.

"What this comes down to is people fighting for the same market," he said.

But Brown cites studies indicating a single Orb has between 60 and 300 times the amount of tobacco contained in a single cigarette. And Greg Connolly, a professor of the practice of public health at Harvard University, calls Orb products "nicotine on training wheels."

R.J. Reynolds, Connolly said, "is just trying to expand the options for nicotine delivery products for the American public."

Smoking a cigarette for the first time, can be a deeply uncomfortable experience for a teenager, Connolly said. Theres the smoke, for one thing, as well as the coughing and the taste. By turning it into a mint-like product - in mint and cinnamon flavors - theyve made nicotine addiction a more pleasurable experience, he said.

Connolly said Browns amendment would allow the FDA to begin the studies necessary to take Orbs off the market. And unless the FDA starts regulating tobacco, he warns, the tobacco industry will continue to get more sophisticated in how it delivers nicotine. If that doesnt happen, he said, "the tobacco companies own the future."

Kiser said despite the fact that the products are only legal for adults, school nurses have reported finding packages of Orbs in the trash.

To her, theyre dangerous because they can be consumed in front of parents and teachers without the adults knowing whats going on.

"Unless a parent knows the exact shape of it, they wouldnt suspect anything," she said.

[nitewriter]

Bill, regardless of what happens, I am so glad we have you speaking out for our rights.

Thank you for all you do on our behalf!

[happily]

You can buy and sell anything in this country if u label it correctly. Someone needs to come up with alternative therapies and names for ecigs and uses for the juice. If manufacturers ship personal aromatherapy devices and oils the fda and others lose their angle.


Bottom line pharmacies, tobacco companies and government (taxes) stand to lose a lot of money if everyone quits smoking analogs.

[LuckyCharm]

Thanks for all you do, Bill. Just tell us how we can help you help us win!

~~Cheryl

[Bill Godshall]

Here's a news article from 2003 when the FDA banned nicotine water (which is now being marketed as a homeopathic remedy), and several months after the FDA banned a nicotine lozenge and a nicotine skin cream. CTFK, ACS, AHA, ALA petitioned the FDA back then to ban these far less hazardous alternatives to cigarettes. I'm still very concerned that we may see similar headlines in the near future announcing the FDA has banned electronic cigarettes (after Obama signs the FDA tobacco bill).

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FDA calls nicotine water illegal drug, bars its sale
Company sought to market it as a diet supplement

AP, Chicago Tribune, 2002-07-03, via tobacco.org
http://www.chicagotribune.com/news/n...163jul03.story

WASHINGTON -- Water laced with nicotine is billed as a
"refreshing break to the smoking habit," but the Food
and Drug Administration ruled Tuesday that it's also
illegal, ending a California company's bid to begin
selling bottles later this month.

The crackdown had been expected since the FDA ordered
nicotine-laced lollipops and lip balm off the market in
April, calling them unapproved drugs that had enough
nicotine to endanger children lured by their resemblance
to candy.

But NicoWater underwent additional scrutiny because
its maker was promoting the bottled water as a dietary
supplement, and the federal agency isn't allowed to
regulate supplements nearly as strictly as it does
medications.

Because nicotine is legally sold over the counter
in FDA-approved smoking-cessation aids, federal law
prohibits its sale as a dietary supplement, agency
lawyers concluded Tuesday. That means NicoWater can't
be sold.

The "FDA's decision underscores our commitment that
consumers be protected from drug products that have
not undergone our rigorous review process," said
Lester Crawford, the FDA acting commissioner.

The manufacturer, QT5 Inc., remained confident that
its water met the definition of a dietary supplement,
but couldn't immediately say if it will challenge
FDA's ruling, said spokesman Ed Haisha.

Anti-smoking activists had pushed the FDA to issue
the ruling, saying allowing nicotine-laced water
would have set a dangerous precedent opening the way
for nicotine to be added many products, including
ones children use.

"The FDA decision is important because it recognizes
nicotine as a powerful drug that needs to be regulated,"
said Matthew Myers of the Campaign for Tobacco-Free
Kids, co-author of a petition filed with FDA against
the products.

The FDA's attempt in the mid-1990s to regulate
cigarettes was stopped by the Supreme Court.

Now nicotine, the addictive ingredient in tobacco, is
popping up in more and more novel products, and the FDA's
reaction has been to deal with them in a patchwork way,
one at a time, after Myers' organization files complaints.

The agency does regulate products containing nicotine
that are marketed as drugs--meaning smoking-cessation
aids like nicotine gum and patches, which underwent
rigorous scientific studies before their sales were
allowed.

In April, the agency stopped pharmacists from
formulating their own nicotine-laced lollipops and
lip balm as alternatives to those products, ruling
they were unapproved drugs.

Haisha said NicoWater, which was to start selling in
retail stores later this month, was never intended
as a smoking-cessation aid but as a boost for smokers
when they can't light up.

"From a practical standpoint, you're on a plane from
New York to L.A., this is to keep you from clawing
the seat in front of you," he said.

He contended users would absorb less nicotine from
the water -- 2 milligrams or 4 milligrams of nicotine
per 16-ounce bottle -- than from nicotine gum. At
those levels, it was touted as having little
aftertaste.

Haisha wondered why anti-smoking activists opposed
a smokeless way of getting nicotine. "It's a way to
keep Susie in the back seat from getting any
secondhand smoke when mommy's driving her to
school."

[Bill Godshall]

Here's another 2002 article announcing the FDA ban of nicotine skin cream and a nicotine lozenge. I believe that the marketers of the nicotine lozenges referred to them as lozenges, and that CTFK referred to them as "lollipops" to falsely imply the products were being target marketed to youth, just as CTFK, Senators Merkley, Brown and other repeatedly referred to RJ Reynold's new tobacco lozenge product (Camel Orbs) as "tobacco candy" to falsely accuse Reynolds of target marketing them to youth last week during the Senate HELP Cmte markup of the FDA tobacco bill).


FDA: Nicotine Lollipops Sold on Web Illegal

Reuters, 2002-04-10, via tobacco.org

WASHINGTON (Reuters) - Nicotine lollipops and lip balms sold by
three pharmacies as aids to quit smoking are illegal, U.S.
regulators said on Wednesday as they warned the firms to stop
selling the products.

The Food and Drug Administration ruled the lollipops and lip balms
are unapproved drugs and therefore need to pass extensive tests to
show whether they are safe and effective.

"FDA is concerned about the health risk of these products," the
agency said in a statement.

Pharmacists had asserted the right to sell the products at stores
and over the Internet under federal rules that permit them to make
medicines easier to take, a practice known as compounding.

The FDA determined that the lollipops and lip balms violated those
rules because some were being sold without a doctor's prescription.
Also, the type of nicotine typically used, nicotine salicylate, is
not permitted in compounding.

In addition, the products did not have proper directions for use and failed to
carry adequate warnings against use by children, the FDA said.

The FDA sent warning letters to Bird's Hill Pharmacy based in
Needham, Massachusetts; Ashland Drug of Ashland, Mississippi; and
The Compounding Pharmacy of Aurora, Illinois. All three firms were
selling the nicotine products over the Internet, the FDA said.

In the letters, the FDA asked the firms to respond within 15 days.
Failure to stop selling the products could lead to further
regulatory action, such as seizure or an injunction.

Larry Frieders, owner of The Compounding Pharmacy, said he
immediately stopped selling the products after he received the FDA's warning on
Wednesday morning.

"I'm disappointed because I think the product we were making was
helping people," he said in an interview.

The lollipops are promoted as a tasty way to give up cigarettes, or
a means for smokers to get a nicotine fix in places where they
cannot light up a cigarette.

[TropicalBob]

I'm still very concerned that we may see similar headlines in the near future announcing the FDA has banned electronic cigarettes (after Obama signs the FDA tobacco bill).

I share your pessimism, having followed this story and practice for almost 17 months. Just substitute "e-cig" for "nicotine water", "lollipops" and "lip balm" in your noted stories, and you'll be reading the ban on e-cigarettes before long.

[Boston George]

RJ Reynold's new tobacco lozenge product (Camel Orbs) as "tobacco candy" to falsely accuse Reynolds of target marketing them to youth

Bill I support you and I support the cause.

But the assertion that RJ Reynold would not try to target kids, is dubious at best.

I support peoples right to smoke if they choose. Moreover, I see smokeless tobacco as the less of evils and therefore should be made widely available.

However, I dont buy that Big Tobacco cares who they get to smoke,chew or whatever. Is the primary intent of Orbs to get kids to use tobacco, I doubt it. Will it get some to start, yea I think so.

[Bill Godshall]

Per Boston George's comment, please note that in 1998 Philip Morris, Reynolds, Lorillard, UST and other tobacco companies signed the Master Settlement Agreement with 46 State AGs that specifically prohibited any of the companies from advertising, promoting, sampling and any other marketing of tobacco to youth (with multimillion dollar fines against any manufacturer caught violating the MSA).

Also, all 50 states have laws that prohibit the sale of tobacco products to minors under 18 years.

And at least 10,000 times more youth smoke Philip Morris Marlboro cigarettes than use RJ Reynolds' Camel Orbs. But those facts didn't seem to concern any of the Senate Democrats who publicly accused (without providing any actual evidence) Reynolds of target marketing Camel Orbs (tobacco lozenges) to youth and repeatedly referrring to the products as "tobacco candy" during last week's US Senate Committee markup of FDA tobacco legislation.

All of the different tobacco products (except one) that were held up by Democrat Senators were made by RJ Reynolds, and all of the products (except one) that were held up by Democratic Senators were removed from the market more than two and half years ago.

And of course, none of the Senate Democrats pointed out that Camel Orbs and other smokeless tobacco products are far far less hazardous than Philip Morris' Marlboro cigarettes (which the legislation protects).

[TropicalBob]

I'm not an RJR fan and this is why: Star Scientific developed a new curing process during preparation for marketing its dissolvables, Ariva and Stonewall. It obtained patents on its process, which virtually eliminated carcinogenic TSNAs.

In 2002, it brought its first product to market.

Good idea, RJR must have said. Let's do it. But it didn't pay Star a cent for Star's patented process when RJR is said to have begun using it. Star sued for patent infringement. RJR filed countering legal mumbo-jumbo. The whole mess was decided -- wildly incorrectly -- by a lower court judge, and then reversed in no uncertain language by the appeals court. It ate up eight years in the courts.

RJR appealed that reversal to the Supreme Court. On March 8 of this year, we read this:

WASHINGTON (Dow Jones)--The U.S. Supreme Court rejected an appeal Monday from R.J. Reynolds Tobacco Co., which is fighting a patent lawsuit by Star Scientific Inc. (STSI).

Star Scientific is a developer of tobacco growing processes that reduce carcinogens in tobacco products. The company sued R.J. Reynolds, a unit of Reynolds American Inc. (RAI), alleging its larger tobacco infringed on patents on tobacco curing processes aimed at lower tobacco specific nitrosamines in tobacco plants.

R.J. Reynolds argued the Federal U.S. Circuit Court of Appeals, a special federal patent court, had wrongly overturned a federal trial judge's holding that it had not infringed on Star Scientific patents. "The Federal Circuit decision here departs from common sense," R.J. Reynolds said.

Star Scientific, in a court brief, called the legal reasoning behind R.J. Reynolds appeal "illusory."

Star Scientific's lawsuit against R.J. Reynolds began in 2001 and the case went to trial in 2005, resulting in a ruling in favor of R.J. Reynolds.. The Federal Circuit reversed the lower court in August 2008.

Star will now present its case for damages to a Maryland jury. In its first quarter report recently released, Star lost $5.2-million. Not from lack of sales. Lawyers to fight RJR don't come cheap.

Will the jury please note that RJR just blessed America with Camel Orbs, Sticks and Strips, dissolvables called "tobacco candy" in Senate HELP committee hearings last week? Will the jury please note how these are virtually the same as Star Scientific's tobacco pellets? Will the jury please sock RJR with a multi-million dollar damage penalty and give the inventor and patent holder the justice he deserves?

Philip Morris isn't the only black-hat American tobacco company.