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American Dental Education Association
Volume 2, No. 89, February 28, 2023
FDA Fines Vape Companies for Ignoring “Stop Selling” Orders
The Food and Drug Administration (FDA) has fined [ [link removed] ] four vape companies for ignoring its stop selling orders. The fines are the first of its kind using the Federal Food, Drug and Cosmetic Act’s premarket review requirements for new tobacco products. The FDA had previously warned the companies that they were in violation of the premarket review requirement and ordered them to stop selling products. However, the companies ignored the order.
This follows the FDA’s action four months ago when it took six other vape shops to court for selling illegal products. These actions come after significant criticisms of the FDA for its lack of appropriate oversight and enforcement of laws and regulations over vape and tobacco companies.
In response to the complaints, the companies must now either pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing by an administrative law judge. The companies risk a default order, which would impose the full penalty amount [ [link removed] ] —statutorily set at $19,192 for a single violation relating to tobacco products—if no action is taken within 30 days of receiving the complaint.
In August 2022, an investigation [ [link removed] ] found that more than half of the 120 companies that the FDA had already warned about selling illegal vapes were still selling their products.
Independent Review Recommends Congress Give New Opioid Authority to FDA
In August 2022, the Commissioner of Food and Drugs Robert Califf, M.D., commissioned an independent review of the Food and Drug Administration’s (FDA’s) programs responsible for improving oversight of opioids and helping to combat misuse. The Ohio State University, who conducted the independent review, recently released its findings [ [link removed] ] . One of its major recommendations was that the FDA should seek “from Congress certain additional authorities regarding opioid analgesic approvals and its review of the advertising and promotion for such products, as well as additional resources to implement such authorities.” Lack of resources, especially human capital, has hampered the FDA’s efforts for years.
The review specifically noted that if additional authorities were granted, the FDA would have the authority to require new opioid products show a benefit over painkillers already available. New opioid products would be required to show a “comparative advantage” over existing treatments.
Currently, the FDA does not have legal authority to do this.
Commenting on using “comparative advantage” as a basis for new opioid approval, Califf stated [ [link removed] ] that comparative advantage has the “. . . potential to, over time, improve the safety of opioid analgesics available to treat severe acute and chronic pain or drive research towards non-opioid alternatives to relieve pain.”
Utah Senate Votes to Increase Autonomy for Dental Hygienists in Public Health Setting
The Utah Senate passed legislation [ [link removed] ] that would increase autonomy for dental hygienists who practice in a public health setting. If signed into law, the bill would authorize the practice of dental hygiene in a public health setting without general supervision and without a collaborative practice agreement with a dentist under the following conditions:
• Prior to engaging in the practice of dental hygiene in a public health setting, the dental hygienist notifies the state’s Division of Professional Licensing that the dental hygienist will engage in the practice of dental hygiene in a public health setting.
• The dental hygienist assumes liability for the work done by the dental hygienist while engaging in the practice of dental hygiene in a public health setting.
• The dental hygienist has liability insurance for the work done by the dental hygienist while engaging in the practice of dental hygiene in a public health setting.
• The dental hygienist refers to a licensed dentist any patient with a dental need beyond the dental hygienist’s scope of practice encountered while engaging in the practice of dental hygiene in a public health setting.
• The dental hygienist sends to the licensed dentist all dental records for the patient generated by the dental hygienist.
The bill has been sent to the state’s House of Representatives for consideration.
Arizona House Passes Bill to Increase Dental Hygienist’s Scope of Practice
The Arizona House of Representatives passed a bill [ [link removed] ] that would include a dental hygiene assessment and hygiene treatment under the scope of practice for dental hygienists. The bill defines dental hygiene assessment as identifying an existing or potential oral health problem that dental hygienists are educationally qualified and licensed to treat. Dental hygiene treatment planning is defined as performing a prioritized sequence of dental hygiene interventions that is predicated on the dental hygiene assessment and that is limited to those services included in the scope of practice for dental hygienists.
The bill has been sent to the state’s Senate for consideration.
Virginia General Assembly Sends Bills on Licensure and Botox to Governor
The Virginia General Assembly passed a pair of bills in late February that, if signed or allowed to become law by Gov. Glenn Younkin (R), could impact the practice of dentistry in the Commonwealth.
HB 2251 [ [link removed] ] would create a workgroup to study issues related to licensure reciprocity for dentists and dental hygienists. The bill would require the workgroup to do the following:
• Compare licensure requirements for dentists and dental hygienists in the Commonwealth with such requirements in other states and the District of Columbia.
• Analyze the number of licensed dentists in the Commonwealth relative to population growth and geography.
• Identify the risks and benefits to the public if a licensure by endorsement pathway were to exist in the Commonwealth.
• Identify any other licensure pathways that would serve the public good.
SB 1539 [ [link removed] ] would allow a dentist to possess and administer botulinum toxin injections for cosmetic purposes, provided that the dentist has completed training and continuing education in the administration of botulinum toxin injections for cosmetic purposes.
ADEA Advocacy in Action
This appears weekly in the ADEA Advocate to summarize and provide direct links to recent advocacy actions taken by ADEA. Please let us know what you think and how we might improve its usefulness.
Issues and Resources
• Applications open [ [link removed] ] for Ryan White Part F Dental Reimbursement Program
• Applications open [ [link removed] ] for HRSA Dental Public Health Research Fellowship
• ADEA report [ [link removed] ] on teledentistry
• ADEA report [ [link removed] ] on the Impact of the COVID-19 Pandemic on U.S. Dental Schools
• ADEA policy brief [ [link removed] ] regarding overprescription of antibiotics
• For a full list of ADEA memos, briefs and letters click here [ [link removed] ] .
Key Federal Issues [ [link removed] ]
ADEA U.S. Interactive Legislative and Regulatory Tracking Map [ [link removed] ]
Key State Issues [ [link removed] ]
The ADEA Advocate [ [link removed] ] is published weekly. Its purpose is to keep ADEA members abreast of federal and state issues and events of interest to the academic dentistry and the dental and research communities.
©2023
American Dental Education Association
655 K Street, NW, Suite 800
Washington, DC 20001
Tel: 202-289-7201
Website: www.adea.org [ [link removed] ]
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B. Timothy Leeth, CPA
ADEA Chief Advocacy Officer
Bridgette DeHart, J.D.
ADEA Director of Federal Relations and Advocacy
Phillip Mauller, M.P.S.
ADEA Director of State Relations and Advocacy
Brian Robinson
ADEA Program Manager for Advocacy and Government Relations
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