Essay Example on The Food and Drug Administration FDA has proposed a Rule

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The Food and Drug Administration FDA has proposed a rule on April 25 2015 to change certain products to be listed as tobacco products This memo will list the way 1 the rule will regulate the newly named tobacco products by implementing the Federal Food Drug and Cosmetic Act s and the Tobacco Control Act s regulations 2 the rule will greatly impact companies involved in the electronic cigarette and hookah industry and businesses attempting to distribute and profit from electronic cigarettes and hookahs and 3 the impacted companies will financially be affected by the restrictions on the sale and distribution of tobacco products POINT 1 RULE SUMMARY The Food and Drug Administration FDA has proposed a rule that will force tobacco products to follow the Federal Food Drug and Cosmetic Act the FD C Act as amended by the Family Smoking Prevention and Tobacco Control Act The Tobacco Control Act allows the FDA to regulate tobacco products that they believe are subject to the law Cigarettes smokeless tobacco and roll your own tobacco are under the FDA's regulatory authority


The FDA wishes to regulate electronic cigarettes cigars pipe tobacco nicotine gels water pipe tobacco certain dissolvables and hookahs Tobacco products include products that contain tobacco and are made for human consumption The regulations that affect tobacco products are restrictions on the sale and distribution of the product The rule s objectives are to include items believed to be tobacco products under the jurisdiction of the FD C Act and to implement provisions on tobacco products in order to protect the public's health Products that are seen to be tobacco products will have to follow the rules implemented by the FD C Act These rules include the prevention of misbranded products of using words such as light or mild and of free samples The rules require that tobacco products come with an ingredient list and that tobacco products meet the premarket review requirements Tobacco products would also have to follow certain Tobacco Control Act regulations These regulations include the need for a minimum age of 18 for purchase required health warnings on the product and advertisements and the prohibition of tobacco vending machines in places where people under the age of 18 have access The FDA has proposed two options to meet both criteria Option 1 would allow the FDA s authorities to regulate all current and future products meeting the tobacco product definition except for the accessories of a tobacco product Components and parts of a finished tobacco product will also be included for regulation under the rule Option 2 would exclude premium cigars from being affected by this proposed rule It has been suggested that different kinds of cigars may have different effects on public health 


This is based on the different number of children consuming premium cigars and how often young adults consume premium cigars The FDA is searching for comments on these options in order to determine whether cigars should be exempt from the rule and to determine what regulations should be imposed on different kinds of cigars On June 24 2014 the FDA extended the comment period for the proposed rule The FDA has decided to extend the deadline due to requests from individuals that have yet to submit a comment POINT 2 IMPACTED COMPANIES RESPONSIBILITIES The big tobacco companies and the small companies involved will have to abide by the regulations of the rule if the rule is implemented Small companies selling electronic cigarettes include VaporFi Halo Cigs and Mig Cigs Small companies selling hookahs include Starbuzz Fantasia and Romman Big tobacco companies in the electronic cigarette business include Philip Morris USA R J Reynolds and Lorillard They will have to follow the regulations under the FD C Act and three rules under the Tobacco Control Act These companies will have to be conscientious of the brands they give their products they must be careful over the wording they place on the product such as light or mild they are prohibited from giving free samples their product must come with an ingredient list and they must meet premarket review requirements Under the Tobacco Control Act the companies are required to impose a minimum age of 18 for purchase their products and advertisements must come with health warnings and the location of tobacco vending machines in areas accessible to people under the age of 18 is prohibited


These rules prevent the companies from making their products flavored a huge part of revenue They also affect businesses selling these products by making it harder to buy for their customers Businesses such as hookah bars and smoke shops will need to make sure the buyer is of age before completing a transaction POINT 3 IMPACTED COMPANIES COSTS The execution of this rule will cause a number of companies and industries to reshape and rethink their infrastructure The rule will elicit an increased burden and make distribution of the product difficult There would be immediate costs because companies would have to follow the registration submission and labeling requirements including warning label provisions and their costs There would also be costs due to the restrictions on advertising and vending machines Option 1 has a primary estimate of 171 1 million for the upfront costs and a primary estimate of 30 6 million for the costs in the following years Option 2 has a primary estimate of 132 8 million for the upfront costs and a primary estimate of 25 million for the costs in the following years


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