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    FDA expands its authority over tobacco products

     

    Additionally, there are provisions that restrict youth access to tobacco products, including:

    • Disallowing products to be sold to persons under the age of 18 years (both in-person and online)

    • Requiring age verification by way of photo ID

    • Disallowing the sale of tobacco products in vending machines (unless in an adult-only facility)

    • Disallowing distribution of free samples

    FDA has authority over tobacco products, which is derived through statute. The final rule was issued to deem the products within the statutory definition of  “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the FDA by regulation deems to be subject to the law. With this final rule, FDA is extending its “tobacco product” authorities in the FDCA to all other categories of products that meet the statutory definition of “tobacco product” in the FDCA, except accessories. 

    As described, the final rule also prohibits the sale of “covered tobacco products” to individuals under age 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. In accordance with the Tobacco Control Act, FDA considers and intends the extension of its authority over tobacco products and the various requirements and prohibitions established by this rule to be severable, which means that if a court should strike down one regulation, it is the intent of the FDA that other regulations would remain in force.

    Ned Milenkovich is chair of the healthcare law practice at Much Shelist PC and vice chair of the Illinois State Board of Pharmacy. Call him at 312-521-2482 or [email protected]

     

    Key Points

    . This article raises pharmacists’ awareness of the expanded role FDA now has over tobacco.

    . In the long-term, this law is intended to curb tobacco use. The pharmacist can educate patients on the dangers of tobacco use and point to the now much more expansive laws and regulations that cover tobacco products.

     

     

     

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...

    2 Comments

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    • [email protected]
      So because of a past Supreme Court's interpretation of the "general welfare" clause in the 30's, we have a central government that regulates everything, including tobacco. Does this sound like a "free country"? So what if tobacco is harmful, we should have the freedom to decide if we want to use it or not. Tobacco regulation (or regulation for most things) does not fall under the enumerated powers of the federal government in the Constitution. Because of the Supreme Court's interpretation, we not have a dictatorial, huge, bloated, debt ridden federal government and our Republic is headed towards socialism and eventually totalitarianism. Thank you, "Men in Black"!
    • [email protected]
      So because of a past Supreme Court's interpretation of the "general welfare" clause in the 30's, we have a central government that regulates everything, including tobacco. Does this sound like a "free country"? So what if tobacco is harmful, we should have the freedom to decide if we want to use it or not. Tobacco regulation (or regulation for most things) does not fall under the enumerated powers of the federal government in the Constitution. Because of the Supreme Court's interpretation, we not have a dictatorial, huge, bloated, debt ridden federal government and our Republic is headed towards socialism and eventually totalitarianism. Thank you, "Men in Black"!