The Food and Drug Administration (FDA) is proposing to limit the content of N-Nitrosonornicotine (NNN) in finished smokeless tobacco products (STP) in order to reduce the risk of cancer associated with STP use. The proposed standard would limit NNN levels to 1.0 mg/g (1 ppm) or less in moist smokeless tobacco, chewing tobacco, dry snuff and other STP throughout the finished product’s labeled expiration date. According to FDA and other data most STP sold in the U.S. do not meet this standard.
Nicotine conversion to NNN can occur during all steps in delivering STP to the consumer from field to retail shelf. Technology does not exist that will allow growers and manufacturers to meet this proposed standard consistently. This proposed standard, if implemented, would force STP manufacturers to test and purchase bales with reduced NNN content. Here in Virginia, this selection process would result in the elimination of contracted dark fire-cured tobacco production and further depress demand for burley tobacco.
FDA is accepting public comment on its proposed standard through July 10, 2017. Please contact FDA and tell them you OPPOSE the proposed standard because it cannot be achieved with current technology and ask them to withdraw the proposed rule.
Virginia Farm Bureau submitted comment earlier this month opposing this proposal. FDA’s standard would damage the livelihoods of dark tobacco and burley growers. Please help us tell FDA to withdraw its proposed standard. You can submit comments by mail or electronically with your smart phone or computer. The proposed rule can be found in its entirety at https://www.regulations.gov/docket?D=FDA-2016-N-2527. Please refer to the talking points and comment instructions below.
Talking Points: Be sure to tailor these talking points to your farm operation.
- FDA must withdraw its proposed standard to limit NNN level in finished smokeless tobacco products.
- NNN conversion in tobacco is highly variable within a given field from year to year and is greatly influenced by warm temperatures and high humidity during production and curing. Tobacco growers have no control over weather conditions.
- FDA’s proposed standard of 1.0 mg/g or less NNN in finished smokeless tobacco products is technically unattainable on a consistent basis. Growers already plant low-converter tobacco varieties and implement soil fertility and curing practices intended to reduce NNN levels with inconsistent, but improved, results. NNN levels remain highly variable and mostly exceed the proposed standard even when using the best available farming practices.
- FDA’s proposed standard will damage the tobacco grower’s economic livelihood and drive growers out of business.
- Tobacco that exceeds the proposed NNN standard will be of little market value or worthless (In many case there are no alternative markets.). Growers will not know if their crop is even marketable until after they have incurred all of their production and curing costs.
- Dark fire-cured and burley growers cannot switch to other tobacco types without incurring significant costs for labor and new specialized curing facilities and equipment. FDA has suggested that growers could switch from raising burley and dark fire-cured tobacco to flue-cured tobacco in order to reduce NNN levels in finished product.
- FDA’s proposed standard will promote the use of foreign tobacco and benefit foreign tobacco farmers at the expense of U.S. tobacco growers. Manufacturers will have to select and purchase reduced NNN level tobacco from foreign countries with dry climates to make up for supply shortfalls of U.S. grown reduced NNN level tobacco.
Paper Submission: Written comments must be postmarked no later than July 10, 2017. Paper submissions must be addressed to and include the following information:
Division of Dockets Management (HFA-306)
Food and Drug Administration
5603 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. FDA-2016-N-2527: Tobacco Product Standard for N-Nitrosonornicotine (NNN) Level in Finished Smokeless Tobacco Products
Electronic Submission: Electronic comments must be submitted before or on July 10, 2017. Comments can be submitted using a smartphone, tablet or computer.
- Go to: https://www.regulations.gov/document?D=FDA-2016-N-2527-0286
- Click on COMMENT NOW!
- Enter your comments into the Comment text box (required)
- Under CATEGORY (required), select Private Industry
- All other text boxes are optional
- Click CONTINUE
- Complete the Preview information
- Click SUBMIT COMMENT
- The next screen should display a confirmation code for comment submission