Comments Needed- Two FDA Proposals Could Have Negative Impact on Tobacco Production

tobacco-1792070_640Below are two Action Alerts concerning FDA proposals, which if ever enacted, would have major negative implications on tobacco production here. At the very least, the manner in which tobacco is grown and marketed would change significantly.

We ask you to comment on each proposal and personalize the comments to your farm and situation. Virginia Farm Bureau will submit additional comments.

You can use the links below to let FDA know what their proposals mean to you.

No later than July 16, 2018, comment on FDA’s proposed nicotine standard herehttps://www.regulations.gov/comment?D=FDA-2017-N-6189-0001.

No later than July 19, 2018, comment on FDA’s proposal to ban flavorings herehttps://www.regulations.gov/comment?D=FDA-2017-N-6565-0001.

ACTION ALERT 1 of 2, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

BACKGROUND

The Food and Drug Administration (FDA) is taking public comment on a potential new rule that would potentially remove 98% of nicotine from traditional combusted cigarettes. FDA is considering the elimination of nearly all nicotine in cigarettes, so they are “minimally addictive or non-addictive” to reduce exposure to toxicants found in combusted cigarettes. Further, FDA may elect to extend the nicotine standard to additional combusted tobacco products, including pipe tobacco and cigars. FDA’s goal is to reduce U.S. cigarette consumption which would significantly reduce demand here in Virginia for both flue-cured and burley tobacco. FDA’s proposal may be viewed at https://www.regulations.gov/document?D=FDA-2017-N-6189-0001

The potential new rule could limit U.S. cigarettes to 0.4-milligram nicotine per gram tobacco filler, or 0.04% nicotine. FDA is also considering other reduced nicotine levels. For comparison, the current nicotine level in U.S. cigarettes ranges from approximately 1.2% to 2.0%. Reducing nicotine content to 0.04%, or similar level is technically unachievable with current tobacco production and post-harvest management and technologies.

Using currently available commercial low-alkaloid varieties, withholding nitrogen fertilizer, and allowing full bloom, 0.04% nicotine cannot be achieved. GMO tobacco may be the only method of achieving the standard, but GMO tobacco will create challenges for U.S. leaf exports for which most foreign customers have zero-tolerance for GMO leaf.  Cigarettes using low-nicotine, or low-alkaloid, leaf, have no taste and lack consumer appeal.

If the low-nicotine standard becomes law and new varieties could be developed along with new production and curing techniques, nicotine content is influenced by weather and highly variable from year to year and from plant to plant within the same row in any given year. Nicotine helps protect the tobacco plant from pest damage. Low-alkaloid tobacco production will require additional pesticide applications to protect the crop from insect and worm damage.

If the low-nicotine standard becomes law, not only will demand for Virginia-grown leaf suffer, but flexibility in marketing a crop would be highly restricted and limited to its end-use. In other words, tobacco would be grown and sold for a specific market or manufacturer for either the domestic market or for export. Domestic leaf sales would be subject to both chemical testing for nicotine content as well as quality grade. If GMO low-nicotine varieties are developed to meet the possible U.S. standard, any grower raising a GMO tobacco crop will not receive a contract with any company that exports U.S. leaf. Furthermore, any, and all, tobacco entering a market would subject to chemical analysis for which there is no rapid test. This means a grower would have to wait days or weeks for test results before being paid for his tobacco, and depending on the test result, may not even be able to sell his tobacco due to its nicotine content or evidence of identified GMO material.

The Tobacco Control Act prohibits FDA from regulating tobacco growers, tobacco production and leaf tobacco not in possession of manufacturers. FDA is attempting to regulate tobacco growers and production by imposing this potential new rule on manufacturers who will not achieve the nicotine standard without imposing the requirement on tobacco growers.

The Tobacco Control Act prohibits FDA from reducing nicotine to zero in tobacco products. By restricting nicotine to 0.0004 grams per gram of tobacco filler (0.4mg/g), a nicotine content level believed to be undesirable by most smokers, FDA is banning nicotine to a level that is effectively zero.

Virginia Farm Bureau Federation will be submitting comments to FDA. However, it is very important that FDA receive comment from growers and consumers.

TALKING POINTS

Please contact FDA and let them know how regulating nicotine would hurt tobacco growers. Be sure to tell FDA how this rule will affect your farm.

  • Tell FDA you support adult consumer access to existing cigarette and other combusted tobacco product brands. You oppose restricting nicotine in cigarettes and other combusted tobacco products. Consumers should have the option of purchasing either traditional cigarettes or very low nicotine content cigarettes.
  • FDA’s proposal will dictate how US tobacco growers raise and cure tobacco leaf on their farms contrary to US law forbidding the regulation of tobacco farms. FDA’s notice lists several actions growers can take to reduce nicotine content in tobacco leaf, including variety selection and managing crop fertility, production, harvest, and curing. It was never the intent of Congress to regulate tobacco growers.
  • It is impossible to produce the proposed very low nicotine content tobacco crop using commercially available varieties adapted to my farm.  Low nicotine varieties that have been developed for research have no resistance to disease and insects. Low nicotine varieties are difficult, if not impossible, to cure using existing techniques.
  • Reducing nitrogen fertilizer, discontinuing topping and harvesting only the lower leaves will reduce leaf yield, quality, and my farm income. Agronomic experimentation with these practices under normal field conditions has failed to consistently lower tobacco leaf nicotine levels to FDA’s proposed level.     
  • Weather is a major determining factor in tobacco leaf nicotine content and is beyond the control of the tobacco grower. If a grower follows all of FDA’s proposed farming practices and produces a low nicotine crop that still exceeds FDA’s proposed nicotine limit due to weather conditions, the crop will be unmerchantable. The domestic market can’t use it and the export market will not want low nicotine content leaf.
  • FDA’s proposal for growers to raise genetically modified (GMO) low-nicotine tobacco plants will eliminate world markets for US tobacco. Seventy percent (70%) of Virginia’s tobacco production is exported to countries that do not want GMO tobacco leaf and have not approved any GMO tobacco leaf for import. Furthermore, foreign buyers do not want to purchase low-nicotine tobacco leaf from US Tobacco growers.
  • FDA’s proposal will force US tobacco growers to raise tobacco for either the proposed low nicotine domestic market or the export market for traditional tobacco leaf, but not both. It will be extremely difficult for tobacco leaf exporters to guarantee the absence of low nicotine and GMO tobacco leaf without limiting their purchases to growers that only raise traditional varieties. Likewise, domestic leaf buyers will only purchase leaf that achieves FDA’s proposed very low-nicotine standard.

SUBMIT COMMENTS

Electronic Comment Submission

Electronic comments must be submitted by Midnight EDT, JULY 16, 2018 at https://www.regulations.gov/comment?D=FDA-2017-N-6189-0001 . Comments may be typed in the Comment box provided or uploaded as a separate file which must include the Docket Number listed below (***). Under the Category drop-down box, select “Private Industry” or “Consumer”.

Written Comment Submission

Written comments postmarked no later than July 16, 2018, can be mailed to:

Dockets Management Staff (HFA-305), FDA

5630 Fishers Lane, Rm 1061

Rockville, MD 20852

***Written comments must include:

Docket No. FDA-2017-N-6189 for “Tobacco Product Standard for Nicotine Level of Certain Tobacco Products”

ACTION ALERT 2 of 2, Regulation of Flavors in Tobacco Products

BACKGROUND

The Food and Drug Administration (FDA) is taking public comment on a potential new rule that would severely limit or even ban menthol cigarettes and flavored tobacco products, including smokeless moist tobacco products. If FDA makes a new flavor rule, it will reduce consumer access to and demand for tobacco products, especially those containing burley and dark-fire leaf tobacco. This action would create financial hardship for many growers. FDA is seeking comments about how flavors attract underage smoking and whether flavors encourage adults to continue tobacco product use or help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products. FDA may establish regulations limiting the flavoring of tobacco products as well as restrict the sale and distribution of flavored tobacco products. The Tobacco Control Act forbids the sale of cigarettes with characterizing flavors (ex. fruit or sweet flavors) while specifically allowing the continued sale of menthol cigarettes. FDA’s proposal may be viewed at https://www.regulations.gov/document?D=FDA-2017-N-6565-0001 .

Virginia Farm Bureau Federation will be submitting comments to FDA. However, it is very important that FDA receive comment from growers and consumers.

TALKING POINTS

Please contact FDA and let them know how regulating flavors could hurt tobacco growers.

  • Tell FDA you oppose youth, or under age 18, use of tobacco products, but you also oppose FDA restricting flavors in any additional tobacco products consumed by adults in an attempt to curb illegal youth tobacco use. Consumers 18 years and older that prefer flavored tobacco products must not be denied the right to purchase flavored tobacco products.
  • Tell FDA that banning menthol cigarettes and adding new flavor regulations limiting adult tobacco product use would further reduce demand for the leaf tobacco grown on your farm. Tell FDA how this action would affect you and your community’s economic livelihoods. Explain the potential loss in terms of dollars, acres or pounds, jobs, etc.
  • By restricting flavors, FDA could create unintended safety consequences while preventing reduced harm tobacco product innovation. Consumers will find flavored black-market tobacco products and alternative methods, including high-risk methods, for flavoring their tobacco products at home without any FDA oversight. Adults should be given access to more legal products that reduce harm, including products with flavors that adults prefer.

SUBMIT COMMENTS

Electronic Comment Submission

Electronic comments must be submitted by Midnight EDT, JULY 19, 2018 at https://www.regulations.gov/comment?D=FDA-2017-N-6565-0001 . Comments may be typed in the Comment box provided or uploaded as a separate file which must include the Docket Number listed below (***). Under the Category dropdown box, select “Private Industry” or “Consumer”.

Written Comment Submission

Written comments postmarked no later than JULY 19, 2018 can be mailed to:

Dockets Management Staff (HFA-305), FDA

5630 Fishers Lane, Rm 1061

Rockville, MD 20852

*** Written comments must include:

Docket No. FDA-2017-N-6565 for “Regulation of Flavors in Tobacco Products”

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