Tobacco Product Standard for N-Nitrosonornicotine Level in the Finished Smokeless Tobacco Products

There is a proposed tobacco product guideline in the US that would keep track of N-nitroso nor nicotine (NNN) component in smokeless tobacco products being sold in the United States of America. This proposal is by Food and Drug Administration agency, (FDA). Smokeless tobacco products have been found to contain NNN which is a potent carcinogenic agent. NNN is also associated with increased cancer risks. I opted for this proposed rule because of its potential to promote quality life years. Yearly, new cases of oral cancer to the tune of 12,700 are reported. Further reports attribute 2,200 deaths to oral cancer in the United States. FDA further estimates that after 20 years of effecting the proposed product standard will result in a total turnaround in these figures.

A substantial amount of authoritative research has shown that users of smokeless tobacco are prone to cancer. This is due to the carcinogenic nitrosamines majorly found in smokeless tobacco products. According to Boffetta at al, (2008) smokeless tobacco products in India and Sudan result to more than 50% of oral cancers. A 2007 monograph by IARC, (International Agency for Research on Cancer) authoritatively reckoned there was substantial proof that smokeless tobacco does cause oral and esophageal cancer in both human beings and experimental animal studies (WHO & IARC, 2007). This proposed rule seeks to reduce the growing numbers of fatal cancers and oral cancer mortality resulting from the toxicant in smokeless tobacco products. The rule seeks to achieve this by ensuring that manufacturers, sellers, and distributors of smokeless tobacco products are compliant to the accepted 1.0 microgram per gram mean level of NNN in any batch.

Some comments have been put forward in support for the rule as well in opposing the rule. These comments are majorly made from users of the products, manufacturers of the products and bodies of research on cancer. Key among them include years of a productive life resulting from a decrease in deaths among oral cancer patients. The annualized value of the gains in a span of 20 years at a 3 percent discount rate is estimated between the values of $228.66 million to $2.46 billion. It is also argued that the estimated cancer risks in smokeless tobacco population will significantly decrease by 65 percent.

Reduced risks of oral cancer are also expected to lead to more public health benefits. Survivors and patients of oral cancer face great problems when performing daily tasks such as talking and eating. This will no longer be so if the proposed rule is adopted. It will also cut the treatment costs associated with oral cancer.

FDA is a regulatory agency. It establishes and modifies the way it regulates several sectors in the US. The sectors include; drugs, foods, biologics, tobacco products, cosmetics, medical devices and radiation emitting electrical products. Its rules, therefore, impacts greatly on the nations economy, health, and industries. These rules also incorporate the publics help where anyone can submit a written comment through the mail or their website on any of the proposed rules. Typically, a substantial amount of time, usually 60 days is given to allow for public participation. In this respect, my comment is that the proposed rule should become law because its important in the realization of a healthy society beyond the millennium developmental goal of combating HIV, Malaria and other diseases.

Implementation of the proposed quantities of NNN per batch would mean that the daily usage of smokeless tobacco products may not have so much of the detrimental effects as there would be on lifetime usage as at current. A conclusion of the draft will be reached after a thorough consideration of the comments given by the public. The process the proposed rule has to go through reveals that regulations are not made in a vacuum or isolation.

References

World Health Organization, & International Agency for Research on Cancer. (2007). Smokeless tobacco and some tobacco-specific N-Nitrosamines. Smokeless tobacco and some tobacco-specific N-Nitrosamines.

Boffetta, P., Hecht, S., Gray, N., Gupta, P., & Straif, K. (2008). Smokeless tobacco and cancer. The lancet oncology, 9(7), 667-675.