ORLANDO – At the Interim Meeting of the American Medical Association (AMA) House of Delegates, physicians and medical students adopted new policies addressing a range of health and safety issues, including protecting the public against unapproved synthetic peptides, modernizing sunscreen regulations, improving electric bike and scooter safety, and preventing lung disease among workers who fabricate engineered stone countertops.
The policies include:
Protecting the public against unapproved synthetic peptides and enforcing patient safety
With the synthetic peptide market expanding quickly, the AMA adopted policy to address mounting concerns that synthetic peptides that have not been approved by the Food and Drug Administration (FDA) lack the safety, efficacy, and quality evidence necessary to support their use.
Under its new policy, the AMA will urge the U.S. Department of Health and Human Services (HHS), the FDA, and relevant federal regulatory authorities to immediately rescind administrative policies, or directives that ease restrictions on compounding and distributing synthetic peptides that lack FDA approval.
“By allowing pharmacies to compound unapproved synthetic peptide substances without sufficient evidence of their safety and efficacy, patients are at increased risk of serious harm. These substances have not undergone the rigorous testing required of FDA-approved drugs, and expanding access without adequate safeguards and oversight could expose patients to serious, preventable harm,” said AMA Board Member Ilse R. Levin, DO, MPH & TM. “We are committed to making sure physicians, other healthcare professionals, and the public are aware of the severe safety risks, lack of clinical data on efficacy, and lack of FDA oversight associated with unapproved synthetic peptide compounds.”
Under the policy, the AMA will also collaborate with federal agencies, state medical boards and state boards of pharmacy to enforce strict regulatory oversight and pursue swift enforcement actions against compounding pharmacies, direct-to-consumer telehealth platforms, and online dispensaries distributing unapproved synthetic peptide formulations that lack FDA regulatory review.
Modernizing sunscreen regulation to help prevent skin cancer
Skin cancer is the most common cancer in the United States; approximately 1 in 5 Americans will develop skin cancer in their lifetime. Furthering its efforts to prevent the risk of skin cancer, the AMA adopted new policy aimed at modernizing the FDA’s review of sunscreen.
Specifically, the policy calls for the AMA to advocate for timely implementation of federal reforms for new sunscreen active ingredient applications, including appropriate consideration of real-world evidence, international safety data, post-market experience, and scientifically validated alternative testing methods as they gain acceptance.
Any reforms should maintain rigorous standards for safety and effectiveness and existing environmental review requirements.
The policy also supports clear and efficient regulatory pathways and other policies that promote the development, evaluation, availability, and adoption of safe and effective broad-spectrum sunscreens in the U.S. Under the new policy, the AMA will support continued post-market surveillance and real-world safety monitoring of newly approved sunscreen active ingredients as an integral component of a modernized regulatory framework.
“Ultraviolet radiation is a major preventable risk factor for skin cancer, including melanoma,” said AMA Board Member and board-certified radiation oncologist Sheila Rege, MD, FASTRO. “We should be able to modernize the way we evaluate new sunscreen ingredients without compromising safety. Giving Americans greater access to safe and effective broad-spectrum sunscreens is a practical step we can take to help prevent skin cancer.”
Improving safety regulations for electric bike and scooter riders
With a rapid increase in the use of micromobility devices such as e-bikes and e-scooters, along with related injuries, the AMA adopted policy aimed at strengthening safety regulations to prevent injuries among riders and others who share the road.
A recent study published in JAMA Pediatrics showed a 33% increase in e-bicycle, and a 15% increase in e-scooter, accidents, emergency room visits and fatalities among children. The study also noted that e-bike and e-scooter injuries are more likely to be more severe than nonmotorized devices.
Under the new policy, the AMA will advocate for Congress to establish a task force to develop recommendations on how states should regulate e-bikes and e-scooters, which would recommend minimum federal standards while allowing states to establish more stringent standards. This includes:
- classification and labeling of electric bikes and scooters,
- licensing and registration requirements,
- age restrictions,
- universal helmet use,
- required rider safety education and public education,
- motor power limits and maximum assistance-speed capabilities,
- night visibility requirements including lighting and reflectors,
- braking performance,
- battery and electrical safety,
- and safeguards against tampering or modification that allows a device to exceed its permitted class, power, or performance limits.
“As more people ride e-bikes and e-scooters, we’re seeing a significant increase in injuries and deaths associated with their use, particularly among children under age 12. To help address this growing public health issue, we must place a greater focus on improving safety regulations, and enforcing them, to prevent more injuries and deaths,” said AMA Board Member Ilse R. Levin, DO, MPH & TM.
The new policy also calls on the AMA to advocate for roadway and transportation infrastructure improvements demonstrated to improve the safety of all roadway users, including traditional and e-bike and scooter users, motorists, and pedestrians. Additionally, the AMA will advocate for parity of enforcement of safety regulations for e-bikes and scooters, including citations and other enforcement actions.
Preventing lung disease in workers who fabricate engineered stone countertops
Engineered stone is the most common countertop material in the U.S. Studies show it poses a severe health risk to fabrication workers and other people who work with the material. Engineered stone contains over 90% crystalline silica. Cutting or dry-grinding this material can create a very fine dust that can be breathed deep into the lungs. This dust can cause silicosis, an incurable occupational lung disease caused by inhaling particles of respirable crystalline silica.
With an increase in silicosis among countertop fabricators across the globe, the AMA adopted policy in support of prohibiting the use of engineered stone countertops and similar products containing more than 1% crystalline silica. Under the policy, the AMA also opposes the manufacturing, importing, distribution, sale, fabrication, and installation of engineered stone products containing more than 1% crystalline silica across the U.S.
“Workers are developing an incurable lung disease that can progress to respiratory failure and sometimes, death, often at a young age among workers,” said AMA Board Member and board-certified radiation oncologist Sheila Rege, MD, FASTRO. “Silicosis is preventable, and the most effective way to prevent silicosis is to use safer countertop materials containing less than 1% crystalline silica with appropriate dust control measures.”
The AMA also supports strengthening silicosis surveillance, improving access to screening and care, and advancing higher-order prevention strategies related to engineered stone countertops.
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