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Excerpts from Tobacco memo may help FDA - Firm says candy idea merely brainstorming

COPY OF MEMO FOLLOWS

by DAVID HANNERS, Pioneer Press [05/23/99]

Opponents say the memo -- which outlines several novel product proposals for tobacco -- may provide the Food and Drug Administration with a powerful piece of evidence that the tobacco industry markets nicotine as a drug that should be regulated.

At a time when the tobacco industry was saying it was doing all it could to make smoking unattractive to kids, once-secret documents show that one cigarette company considered new tobacco-based candies including lollipops, fruit roll-ups and a ``cotton candy like product.''

The ideas were among several novel tobacco products to emerge during an October 1992 brainstorming session by executives at Brown & Williamson Tobacco Corp., according to a memo from the meeting.

But tobacco opponents say the memo may provide the Food and Drug Administration with a powerful piece of evidence that the tobacco industry markets nicotine as a drug that should be regulated. The U.S. Supreme Court last month agreed to rule on whether the FDA can regulate tobacco.

A public health official who fights tobacco use says the impetus for nonsmoking uses of tobacco comes, in part, from scientific findings that the burning of tobacco is what releases many of the cancer-causing agents in the leaf.

``What they're caught with is, the most efficient way to get nicotine to the brain is also the most deadly way. Patches, gum, inhalers and even smokeless cigarettes can't compete with that,'' said Dr. Gregory Connolly of the Massachusetts Department of Public Health's Tobacco Control Program.

``I think what they're struggling with,'' Connolly said, ``is `How do we get into the market innovative ways of getting nicotine into the system without killing them?' I think they need something out there to compete with a conventional cigarette that doesn't carry a lot of junk with it.''

The thinking behind the memo, however, underscores an issue dividing the tobacco control movement: Are any uses of tobacco acceptable?

``For a long, long time, there was a feeling among tobacco control advocates that we had to fight against any use of nicotine,'' said John Banzhaf, executive director of Action on Smoking and Health. ``Some of the people are now suggesting that while it (alternative uses of tobacco) isn't good, it may be the lesser of two evils and at least an acceptable short-term solution to addiction.''

The tobacco industry has fought past efforts by the FDA to regulate cigarettes, and it is challenging the current effort by the federal agency.

At issue is whether the tobacco companies market nicotine as a drug that can be regulated by the FDA. The FDA staunchly maintains nicotine should be regarded as a drug and cigarettes as drug delivery devices that must be regulated just like other drugs. Cigarettes aren't currently regulated by the agency. Ironically, the tobacco items proposed in the Brown & Williamson memo would have fallen under FDA jurisdiction as food products or additives. Under this system, to be used in a food tobacco would have to be proven risk free; to be approved as a drug, the FDA weighs the risk of use against the benefits.

To that end, Banzhaf said the newfound memo ``is one of the strongest pieces of evidence supporting the FDA's position that they (tobacco companies) intended nicotine as a drug.''

``What they're basically talking about here is `How do we cram nicotine into people?' '' said Banzhaf. ``They're talking about how it has to be at certain levels, and they even use the word `controlled,' and that is at the heart of the FDA's case.''

Popcorn cigarettes

The memo is among 36 million pages of documents housed at the Minnesota Tobacco Document Depository, set up in Minneapolis as part of the state's lawsuit against the major tobacco companies. As part of the $6.6 billion settlement reached a year ago between the state and the major tobacco companies, the long-secret documents are now public.

Documents show that the major tobacco companies -- Brown & Williamson, Philip Morris Inc., R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co. -- investigated a variety of novel tobacco and smoking products.

The companies' research took place amid the backdrop of the scientific community's growing concerns about the health hazards of tobacco use, as well as government's increased emphasis on regulating tobacco use. As a result, their research into unusual concepts took two tracks: They sought tobacco products that didn't involve smoking, or cigarettes made of substances other than tobacco.

For example, memos show scientists at R.J. Reynolds investigated cigarettes made from ground peanut shells, pulverized corncobs, tomato leaves, puffed rice and coffee bean hulls.

Philip Morris tested a variety of grains, documents show. In particular, in the early 1980s the firm's scientists were enamored of the concept of a popcorn cigarette (they preferred Orville Redenbacher Gourmet Popping Corn), and one 1983 memo refers to the popcorn cigarette having a ``mild yet pleasant odor when burned.''

Foods made from tobacco discussed in the memo included a wafer bread product; ``foam tobacco; sponge or cotton candy like product;'' a fruit roll-up; tea; a paper stick resembling a lollipop; a ``chew stick;'' tobacco spice to sprinkle on food; a ``tobacco-derived salted snack'' and a tobacco pill.

The company also looked at an ``asthma inhaler-like product,'' a nicotine nasal spray, chewing tobacco that didn't have to be expectorated, tobacco toothpicks and an ``atomizer activated by sucking.'' It considered tobacco lotion, perfume and aftershave.

(B&W) PROTECTED BY MINNESOTA TOBACCO LITIGATION PROTECTIVE ORDER
  
        BROWN & WILLIAMSON TOBACCO CORPORATION
    
        RESEARCH & DEVELOPMENT
    
        INTERNAL CORRESPONDENCE
    
        TO:   J. S. Wigand
     CC:   A. J. Golub   R. A. Gonterman
           E. F. LitzingerS. Magenheimer
           F. K. St.CharlesJ. . Y. Tang
    
     FROM:  S. Appleton
    
     DATE; October 6, 1992
    
    SUBJECT:  BRAINSTORMING SESSION ON NOVEL TOBACCO PRODUCTS/320
    
   A half-day brainstorming meeting on novel tobacco product
development was held at the Holiday Inn South West in Louisville
on October 5. 1992. The participants included the copied    individuals and myself
    
DESIRABLE ATTRIBUTES

        The meeting began with Brain Storming,to identify attributes of a "socially acceptable" tobacco product. The following attributes were identified:
    
    . No smoke         - Can be used discretely
    - No expectoration   Simplified chemistry
    . No odor            Satisfaction readily controlled by user
      Fire safe          Contains nicotine
      No residue after use   Positive image
      Easy disposal      Contains natural nicotine
      Readily available  .   All derived from tobacco
      No regulatory issues    Can be used anywhere
      Pleasant flavor  - Easy to use
      Easy to carry    - Stable
      Durable          - Pleasant to use
      Right price
      No teeth stain
      Clear.
    

(B&W) PROTECTED BY MINNESOTA TOBACCO LITIGATION PROTECTIVE ORDER
    
                                    .2-
    
    PRODUCT-CONCEPTS
    
        Brain storming was next conducted to identify product concepts. The following concepts were identified:
    
     Skoal bandit-like product . "spitless" chewing tobacco
     Wafer/unleavened-bread    - Tobacco beverage i.e. tea
       like product              Toothpick-like Product
     Gum/jell based product      Tobacco as spice for food
     Polysaccharide film        Paper stick. lollypop-like
     Tobacco based paper and extract    Repetition dry snuff
     Toasted stem pith           Tobacco pill
     Seaweed sheath              Tobacco derived salted snack
     asthma inhaler-like product  Tobacco foam for intra-nasal
     Nicotine nasal spray            application
     Foam tobacco; sponge or     Tobacco lotion
       COMA candy like product   Tobacco plaster
     Puffed/expanded/crisp type product      Electric cigarette;
     chew stick                   vaporizes nicotine
     Cinnamon stick              Atomizer activated by
     Plastic impregnated with     sucking
       tobacco/extract           Tobacco extract in perfume
     Wax impregnated with         or aftershave
       tobacco/extract
     Fruit roll up like product
      made with tobacco

PRODUCT POSITIONING
    
    Brain storming was next conducted for possible product
    positioning. The following list of positions was developed:
    
    .  When you can't smoke   . For mature adults
    .  Instead of a snack     .   For relaxation
    -  A "clean" chew             . Lift your spirits
    -  Simplified chemistry   - For focus & concentration
    -  socially acceptable    - The "PREMIER" of chewing
    .  Can be used anywhere       tobacco
    .  Tobacco satisfaction at less cost
    -  A slice of "Americana"
    -  Clean, refined, high tech. for
       educated, sophisticated people
    -  The next generation for
       tobacco Satisfaction
     Can be used discretely
    
CONCEPT PRIORITIZATION & GROUPINGS
    
    We next reviewed come regulatory issues for the purpose of
    guiding our product concept prioritization exercise. These
    included the legal definitions of "smokeless tobacco". "food" and "drug". We Also reviewed the case history of Pinkerton Tobacco's Masterpiece Tocacs As wall as some patent issues,

(B&W) PROTECTED BY MINNESOTA TOBACCO LITIGATION PROTECTIVE ORDER
    
                                           -3-
    
        Following this exercise some product concepts were excluded as likely possibilities. The remaining viable product concepts fell into 4 major groupings. These were ranked according to conformance to attributes of a socially acceptable tobacco product, regulatory considerations anticipated development time, and anticipated investment into new technology,
    
CELLULOSE, NICOTINE FLAVOR
    
        This product would be essentially a clean paper-like sheet with purified tobacco extract containing nicotine and added flavor.  Nicotine concentration would be controlled such that expectoration would not be required with product use. This represents the purist 6 cleanest farm of a novel chewing tobacco product. It satisfies the greatest number of desirable attributes. It Is anticipated that such a product could be derived entirely from tobacco. However, it would take an estimate of greater than 3 years of development time. It would also require new technology in tobacco extraction, separation and reconstitution technology.
    
CHEWABLE FILMS & SHEETS
    
        These products could include various forma of reconstituted tobacco shear or dissolvable, gel-type films containing tobacco extract and flavor.  Nicotine concentration would be controlled such that expectoration would not be required with product use. It is anticipated that such a product could be derived entirely from tobacco. These products war& intermediate In conforming to desirable attributes.  Assuming that such a product was made with no prior base sheet or extract clean up, development time for products is estimated to be in the range of 2 to 5 years. Some extraction separation and reconstitution technology may be needed depending upon the specific, product concept.
    
CHEWABLE STICK PRODUCTS
    
        These products could include various forms of a chewable stick
which could be fabricated from extruded tobacco, rolled reconstituted tobacco sheet, pressed tobacco fiber. Nicotine concentration would be controlled such that expectoration would not be required with product use. It is anticipated that such a product could be derived entirely from tobacco. These products were intermediate in conforming to desirable attributes. Assuming that such a product was made with no prior base sheet or extract clean up, development time for products is estimated to be in the range of 2 to 5 years. Some extraction, separation and reconstitution technology may be needed depending upon the specific product concept.


    
MODIFICATIONS OR REPOSITIONING OF CURRENT STP PRODUCTS
    
        These concepts mostly involve repositioning of conventional   smokeless tobacco products. Such a product could be. developed in less than 2 years. It is possible that no now technology would be needed a number of alternate "smoking" products were discussed. These fell largely in the category of vaporizers or aerosol inhalers, -They were not pursued in detail due to Chit relatively large technology investment anticipated and- the existing patent coverage already existing for such products.

(B&W) PROTECTED BY MINNESOTA TOBACCO LITIGATION PROTECTIVE ORDER
    
NEXT STEPS
    
        Next steps might involve talking to Marketing about the viability of the various product concepts and positioning. Focus groups could be held with consumers to determine potential interest. Such focus groups would be most productive if product prototypes were available. it is anticipated that such prototypes could be made in R&D.

S. Appleton