In a move to protect consumers against tobacco-induced diseases, the FDA finalised a rule to obtain greater regulation on all tobacco products. Such products include e-cigarettes, pipe tobacco, cigars and hookah tobacco. The rule, which became effective on 8 August 2016, serves as a response to products presently being without full ingredient reviews, correct age restrictions and manufacturer details.
What does the rule mean?
The FDA has been regulating the majority of tobacco products since 2009; however, the new rule gives it further authority to regulate illegal sales to minors, marketing and distribution. The new rule plans to cut down on sales to minors by not allowing tobacco products to be sold in vending machines available to under 18s and by placing stricter measures on photo ID requirements. Additionally, the FDA will now ban free samples of tobacco products and health warnings will be required for cigarette tobacco, roll-your-own tobacco and other newly-released products. Products that have been introduced to the market since 15 February 2007 will need to demonstrate that they meet legal health standards.
A crucial implication of the new rule is the FDA’s regulatory authority for the wider range of tobacco products that are now available. Products including e-cigarettes, nicotine gels and dissolvable tobacco will now be under the remit of the FDA to monitor correct practice.
How will it affect you?
The new rule has a variety of implications for manufacturers, retailers and consumers. There is an increased amount of information available on products and online to help consumers make informed health decisions when purchasing products. If the rule affects your line of work, there are plenty of companies to help with FDA 510k, such as http://www.fdathirdpartyreview.com/.
Manufacturers are expected to continue selling their products for up to two years while submitting; an additional year will be given for the FDA to review new product applications. The authority plans to prevent any new tobacco products being marketed; however, there may be exceptions where the manufacturer can validate that health standards are being met.
Retailers that mix, make or modify products will also be classified as manufacturers. As of 10 May 2018, it will be illegal for retailers to sell, display or distribute any tobacco products without health warnings on the package.