Food And Drug Administration Regulations Research Articles

Staying Out of Trouble: FDA Regulation of Orthobiologics and the Shoulder Surgeon

Food and Drug Administration (FDA) regulation of Orthobiologics can be challenging to interpret for the non-regulatory scientist. However, understanding how regulations apply to clinical use of these orthobiologic products is critical, as there are both ethical and legal ramifications to using orthobiologics in conflict with regulations. Recent FDA guidances have attempted to clarify these issues, although questions still remain regarding nuances in regulatory applications. FDA guidances, industry blogs, and relevant publications were searched for citations regarding recent orthobiologics and regulations. These sources were compiled into a current assessment of FDA regulations regarding the use of orthobiologics in the shoulder. Key to understanding these regulations is the FDA differentiation of human cellular and tissue based products (HCTPs) into 361 and 351 category products. While some controversy still exists, FDA has attempted to clarify these issues with several recent guidances. Of equal importance, FDA has ended enforcement discretion for many biologic products in June of 2021, creating a previously tolerated class of orthobiologics that now requires an Investigational New Drug (IND) application and subsequent Biologic License Application to legally market these orthobiologics. The Same Surgical Procedure Exception was further clarified in 2017 to exempt facilities from regulatory controls when specific guidelines are met. This article attempts to clarify the current thinking on FDA regulations and will allow the shoulder and elbow surgeon to stay within the current bounds of ethical and legal use of these products.

FDA Regulation of Menstrual Devices: Increased Innovation, Decreased Oversight, and Shifting Problems

Innovation in menstrual cups and panties addresses “period poverty” and ecological sustainability. However, menstrual cups and panties are not currently subject to Food and Drug Administration (FDA) review. We used data from three U.S. FDA databases and found an increase in adverse event reports associated with menstrual cups and that one-quarter of registered establishments have generic menstrual cups without brand names. Menstrual cups may be beneficial ecologically and economically because they replace single-use devices. However, there are health issues associated with cups, which may increase in incidence as their usage increases during a time when the FDA has reduced safeguards.

Signs and symptoms: Adverse events associated with a sterilization device

Sterilization is now the most common contraceptive method used by women of in the U.S., and sterilization devices have played an important role in its increased popularity. This mixed methods study examines a random sample of 2500 U.S. Food and Drug Administration (FDA) adverse event reports made between 2006 and 2017 about Essure, a sterilization device. Quantitative coding was used to examine patient problems; pain and bleeding were reported most frequently. Qualitative coding analyzed impacts of symptoms on patients' everyday lives and patients' healthcare experiences, including intimate relationships, mothering, and paid employment. Findings suggest that some patients struggled when their reported “subjective” symptoms didn't result in “objective” clinical signs of problems, and when physicians dismissed or deflected their concerns in diagnostic encounters. This paper raises important issues regarding the symptoms patients associated with Essure, the diagnosis of device-driven disease and injury, and the FDA's regulation of medical devices.

Over-the-counter hearing aids: implementations and opportunities

After decades of effort by shareholders, including government agencies, patient advocacy groups, and professional organizations, the U.S. Food and Drug Administration (FDA) established a new medical device category for over-the-counter (OTC) hearing aids on October 17, 2022. This FDA regulation allows adults aged 18 years or older with perceived mild-to-moderate hearing loss to purchase OTC hearing aids without a prescription or even a hearing test. The goal is to increase hearing aid accessibility, potentially leading to improved hearing and a better quality of life. In our analysis of the FDA Establishment Registration & Device Listing database, we found that the current OTC hearing aid market is still dominated by traditional hearing aid manufacturers, with limited disruptor from major consumer electronics and startup companies. Our technological analyses showed that the relatively high-level output specification without gain limitation allows sufficient amplification even for people with severe-to-profound hearing loss. Additionally, borrowing from the cochlear implant mapping strategy, we propose novel amplification algorithms for fitting OTC hearing aids without an audiogram. We argue that smartphones and true-wireless-stereo earbuds can functionally serve as OTC hearing aids, further increasing accessibility and affordability while reducing the stigma associated with hearing aids, especially in low- and mid-income countries. By treating more people at a younger age with less hearing loss than traditional prescription hearing aids, OTC hearing aids can potentially have a significant impact beyond hearing care, such as delaying or preventing cognitive decline in the elderly.

Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey.

Physicians' knowledge of Food and Drug Administration (FDA) approval processes is important in informing clinical decisions and patient discussions. Among a randomly selected national sample of 509 internists, cardiologists, and oncologists, 41percent reported moderate or better understanding of the FDA's drug approval process, and 17percent reported moderate or better understanding of the FDA's medical device approval process. Nearly all physicians thought that randomized, blinded trials that met primary endpoints should be very important factors required to secure regulatory approval. Also, nearly all physicians thought that the FDA should revoke approval for accelerated-approval drugs or breakthrough devices that did not show benefit in postapproval studies. Our findings suggest that physicians commonly lack familiarity with drug and medical device regulatory practices and are under the impression that the data supporting FDA drug and high-risk device approvals are more rigorous than they often are. Physicians would value more rigorous premarket evidence, as well as regulatory action for drugs and devices that do not demonstrate safety and effectiveness in the postmarket setting.

Identification and Characterization of Synthetic Nicotine Product Promotion and Sales on Instagram Using Natural Language Processing.

There has been a rapid proliferation of synthetic nicotine products in recent years, despite newly established regulatory authority and limited research into its health risks. Previous research has implicated social media platforms as an avenue for nicotine product unregulated sales. Yet, little is known about synthetic nicotine product content on social media. We utilized natural language processing to characterize the sales of synthetic nicotine products on Instagram. We collected Instagram posts by querying Instagram hashtags (eg, "#tobaccofreenicotine) related to synthetic nicotine. Using Bidirectional Encoder Representations from Transformers, collected posts were categorized into thematically related topic clusters. Posts within topic clusters relevant to study aims were then manually annotated for variables related to promotion and selling (eg, cost discussion, contact information for offline sales). A total of 7425 unique posts were collected with 2219 posts identified as related to promotion and selling of synthetic nicotine products. Nicotine pouches (52.9%, n = 1174), electronic nicotine delivery systems (30.6%, n = 679), and flavored e-liquids (14.1%, n = 313) were most commonly promoted. About 16.1% (n = 345) of posts contained embedded hyperlinks and 5.8% (n = 129) provided contact information for purported offline transactions. Only 17.6% (n = 391) of posts contained synthetic nicotine-specific health warnings. In the United States, synthetic nicotine products can only be legally marketed if they have received premarket authorization from the Food and Drug Administration (FDA). Despite these prohibitions, Instagram appears to be a hub for potentially unregulated sales of synthetic and "tobacco-free" products. Efforts are needed by platforms and regulators to enhance content moderation and prevent unregulated online sales of existing and emerging synthetic nicotine products. There is limited clinical understanding of synthetic nicotine's unique health risks and how these novel products are changing over time due to regulatory oversight. Despite synthetic nicotine-specific regulatory measures, such as the requirement for premarket authorization and FDA warning letters issued to unauthorized sellers, access to and promotion of synthetic nicotine is widely occurring on Instagram, a platform with over 2 billion users and one that is popular among youth and young adults. Activities include direct-to-consumer sales from questionable sources, inadequate health warning disclosure, and exposure with limited age restrictions, all conditions necessary for the sale of various tobacco products. Notably, the number of these Instagram posts increased in response to the announcement of new FDA regulations. In response, more robust online monitoring, content moderation, and proactive enforcement are needed from platforms who should work collaboratively with regulators to identify, report, and remove content in clear violation of platform policies and federal laws. Regulatory implementation and enforcement should prioritize digital platforms as conduits for unregulated access to synthetic nicotine products and other future novel and emerging tobacco products.

Early Introduction of Novel and Less-Studied Food Allergens in the Plant-Based Era: Considerations for US and EU Infant Formula Regulations

Early life feeding practices may affect the long-term health of individuals, particularly in terms of the development of non-communicable diseases, such as metabolic and allergic diseases. Accumulating evidence suggests that the interplay of breastfeeding and/or formula feeding followed by the introduction of solids plays a role in the occurrence of non-communicable diseases both in the short and long term. International food allergy guidelines recommend that breastfeeding women do not need to avoid food allergens and do not recommend any infant formula for allergy prevention. Guidelines regarding solid food introduction for food allergy prevention recommend the introduction of well-cooked eggs and peanuts around 4–6 months of age, and not to delay the introduction of other food allergens. There is also an increasing trend to feed infants a plant-based or plant-forward diet and have access to infant formulas based on plant-based ingredients. The use of novel plant-based infant formulas raises a few questions reviewed in this paper: (1) Do fortified, plant-based infant formulas, compliant with US Food and Drug Administration (FDA) regulations and European Food Safety Authority (EFSA) (European) guidelines, support adequate infant growth? (2) Are plant-based infant formulas suitable for the management of cow’s milk allergy? (3) Does feeding with novel, plant-based infant formulas increase the risk of food allergies to the food allergens they contain? (4) Does feeding infants plant-based food allergens in early life increase the risk of allergic and severe allergic reactions? The review of the literature indicated that (1) plant-based formulas supplemented with amino acids and micronutrients to comply with FDA regulations and EFSA guidelines, evaluated in sufficiently powered growth studies, can support adequate growth in infants; (2) currently available plant-based infant formulas are suitable for the management of CMA; (3) an early introduction and continuous intake of food allergens are more likely to prevent food allergies than to increase their risk; and (4) an early introduction of food allergens in young infants is safe.

LC-MS/MS Investigation of nitrosamine impurities in certain Sartan group medicinal products available in Istanbul, Türkiye

Nitrosamines (NAs) are molecules that include the nitroso functional group. In 2018, the US Food and Drug Administration (FDA) received its first report of NAs in pharmaceuticals. The fact that NA impurities are likely human carcinogens is relevant to these compounds. Furthermore, prolonged exposure to NA contaminants above safe limits may raise the risk of cancer. The goal of this article was to assess the amounts of six different NAs in Sartan group medicines purchased from formal pharmacies in Istanbul, Türkiye, using a validated LC-MS/MS assay. An LC-MS/MS-based analytical assay was undertaken. The separation was performed with a HR ODS 150mm×3.0mm and 5-analytical columns, providing effective separation of major peaks from NA impurities. In mobile phase A, formic acid was 0.10% in water, while in mobile phase B, formic acid was 0.10% in methanol. The flow rate was 0.4mL/minute, and the total runtime was 18minutes with the gradient elution mode. The validation was conducted in line with ISO/IEC 17025 requirements. Up to 100μg/L, linearity was determined using correlation coefficients (r2>0.995) for all NAs. The limit of quantification values for all NAs analyses were below 1.0μg/L. The mean recovery value obtained during the spike experiment was 95.18%, demonstrating the accuracy of the procedure. In addition, the accuracy was shown by a certified reference analysis, which yielded relative standard deviation and relative error values of 1.82% and 3.34%, respectively. During the intermediate precision testing, bias and relative standard deviation were 0.96 and 2.87%, respectively. Of the 75 study samples involving Sartan group medical products, no nitrosamine impurities were detected, demonstrating that pharmaceutical companies have adequate medication safety precautions in place in accordance with FDA and European Medicines Agency (EMA) regulations published to prevent NA contaminants in human medicinal products.

Poster 378: The Availability and Price of Orthobiologic Injections in the Chicagoland Area: A Market Assessment Study

Objectives: Orthobiologic therapies have recently gained popularity in orthopaedic surgery as potential treatment options that can be used to manage the symptoms of musculoskeletal conditions. However, the market for these products remains unregulated by the Food and Drug Administration (FDA), giving rise to a wide range of available yet untested products. There are growing concerns related to patient safety and product efficacy, but also in regard to the amount of money being charged by providers for these treatments Thus, the purpose of this study was to investigate the current market for orthobiologic injections for knee osteoarthritis in a large, metropolitan city and determine 1) the willingness of providers to disclose the cost of an injection prior to an appointment; 2) the cost of injections if disclosed; 3) the cellular source of injections being advertised as “stem cell” products; and 4) whether there are differences in the market for orthobiologics within and outside of orthopaedic sports medicine practices. Methods: Orthopaedic sports medicine providers in the Chicagoland area were identified through the American Orthopaedic Society for Sports Medicine (AOSSM) and Arthroscopy Association of North America (AANA) registries of sports medicine physicians seeing patients in at least one location within the Chicagoland area. Non orthopaedic clinics (including chiropractors, pain management physicians, and self-advertised “regenerative medicine” clinics) offering orthobiologic injections were compiled using Yelp! and Google search for listings and reviews containing the following key words: “PRP” or “platelet-rich plasma” or “platelet rich plasma,” “SCT” or “stem cells” or “amniotic tissue injections” or “adipose stem cell injections,” and “BMAC” or “bone marrow aspirate concentrate.” A single author [BLINDED] contacted every clinic via a common telephone script, which was modified from an existing study. Data was collected for each site on the types of injections offered, whether price was disclosed over the phone, the price of injections offered, and the source of alternative “stem cell” injections if they were provided. Prices were explicitly specified as being for one injection of one joint. Results: A total of 25 orthopaedic sports medicine practices (comprising 80 AOSSM/AANA surgeons) and 40 non orthopaedic clinics offered at least one of either PRP, “stem cell,” and/or BMAC injections over the phone (Table 1). There was no difference in the likelihood of providing PRP injections (p = 0.698) or BMAC injections (p = 0.340). However, non orthopaedic clinics were significantly more likely to offer “stem cell” injections (p < 0.001). There was no difference in the willingness to disclose the price of PRP without an appointment (p = 0.269), willingness to disclose the price of “stem cell” injections (p = 0.302), willingness to disclose price of BMAC (p = 0.528), or willingness to disclose the source of what each clinic advertised as “stem cell” injections (p = 0.302). While the average price of a BMAC injection was not different between provider types (p = 0.238), the average price of a single PRP injection was significantly higher (p = 0.011) and significantly more variable (F statistic = 0.139; p < 0.001) at non orthopaedic clinics (Figure 1). Similarly, the average price of a single “stem cell” injection was significantly higher (p < 0.001) and significantly more variable (F statistic = 0.080; p = 0.025) at non orthopaedic clinics. Most commonly, alternative “stem cell” products included amniotic-based injections, which are currently discouraged for distribution or use based upon the most recent FDA guidance document. Conclusions: When compared to orthopaedic sports medicine providers, non orthopaedic clinics providing orthobiologic treatments in the Chicagoland area are more likely to offer alternative “stem cell” injections and charge a significantly greater and more variable amount per PRP and “stem cell” injection. Unfortunately, there was liberal use of the terms “regenerative medicine” and “stem cell” therapies in the face of increased scrutiny related to the FDA’s current position on cell-based therapies. Future studies should examine these trends on a national scale to assess compliance with FDA regulations on orthobiologics, as well as establish standards of price for these treatments. [Table: see text]

Data transparency and demographic representation in approval packages of FDA-approved oncology drugs from 2012-2021.

1594 Background: Over the past decade, the U.S. Food and Drug Administration (FDA) has leveraged regulations and guidance documents to accelerate improvements in demographic reporting and encourage adequate representation of minorities in clinical trials. This cross-sectional study aims to assess the impact of these interventions by characterizing demographic data reporting and representation by sex, age, and racial and ethnic identity in pivotal trials supporting novel cancer therapeutics approved by the FDA from 2012 through 2021. Methods: Study demographic data were abstracted from FDA drug approval packages and US cancer population demographic data was abstracted from US Cancer Statistics. The percentages of trials reporting sex, age, racial and ethnic identity of participants in drug approval packages were calculated and participation to prevalence ratios (PPRs) were calculated by dividing the percentage of participants in each demographic by the percentage of the US cancer population in each group. PPRs were constructed for each pivotal trial by cancer type. Adequate representation was defined as PPR 0.8-1.2 and the proportion of trials which were adequately representative of each demographic was calculated and trended over time. Results: From 2012 through 2021, the FDA approved 118 cancer therapeutics, based on 131 pivotal trials. For drugs approved 2012-2016, the majority of associated pivotal trials reported participation based on sex (100% of trials), age (100%) and White (98%), Black (75%) or Asian (84%) racial identity, but not American Indian or Alaskan Native racial identity (18%) or Hispanic ethnic identity (41%). For drugs approved 2017-2021, there were no significant improvements in demographic data reporting, although there was a trend towards increased reporting on Hispanic ethnic identity from 2012-2016 (41%) to 2017-2021 (65%) (p= 0.06). For drugs approved 2012-2016, most pivotal trials adequately represented female participants (78% of trials) and participants identifying as White (87%), but few pivotal trials adequately represented older adults (7%), participants identifying as Black (11%), American Indian or Alaskan Native (0%), Asian (18%) or Hispanic (5%). Representation in pivotal trials did not significantly improve for any demographic for drugs approved 2017-2021 (p>0.05). Conclusions: This study found that the last decade’s efforts to improve demographic data transparency and representation in clinical trials have not yet borne fruit for novel cancer therapeutics. More consequential FDA regulations may be necessary. Beyond the FDA, demographic data transparency and adequate minority representation in oncology clinical trials is an all-stakeholder responsibility. A more just clinical trial infrastructure requires greater collaboration between the FDA, sponsors, enrollers, contract research organizations and cooperative groups.

Tobacco Product Use Among Adults – United States, 2021

Commercial cigarette smoking among U.S. adults has declined during the preceding 5 decades (1,2); however, tobacco product use remains the leading cause of preventable disease and death in the United States, and some populations continue to be disproportionately affected by tobacco use (1,2). To assess recent national estimates of commercial tobacco use among U.S. persons aged ≥18 years, CDC, the Food and Drug Administration (FDA), and the National Cancer Institute analyzed 2021 National Health Interview Survey (NHIS) data. In 2021, an estimated 46 million U.S. adults (18.7%) reported currently using any tobacco product, including cigarettes (11.5%), e-cigarettes (4.5%), cigars (3.5%), smokeless tobacco (2.1%), and pipes (including hookah)* (0.9%).† Among those who used tobacco products, 77.5% reported using combustible products (cigarettes, cigars, or pipes), and 18.1% reported using two or more tobacco products.§ The prevalence of current use of any tobacco product use was higher among the following groups: men; persons aged <65 years; persons of non-Hispanic other races; non-Hispanic White (White) persons¶; residents of rural (nonmetropolitan) areas; financially disadvantaged (income-to-poverty ratio=0-1.99); lesbian, gay, or bisexual (LGB) persons; those uninsured or enrolled in Medicaid; adults whose highest level of education was a general educational development (GED) certificate; who had a disability; and who had serious psychological distress. Continued surveillance of tobacco product use, implementation of evidence-based tobacco control strategies (e.g., hard-hitting media campaigns, smoke-free policies, and tobacco price increases), conducting linguistically and culturally appropriate educational campaigns, and FDA regulation of tobacco products will aid in reducing tobacco-related disease, death, and disparities among U.S. adults (3,4).

FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate.

Technological progress in digital therapeutics-and, in particular prescription digital therapeutics (PDTs)-has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Digital therapeutics have entered the health care ecosystem so rapidly that substantial misunderstandings exist about how they are evaluated and regulated by the FDA. This review briefly explains the relevant regulatory history of software as medical devices (SaMDs) and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are developed and approved for use. These are important issues because PDTs, and digital therapeutics in general, are an explosively growing field in medicine and offer many advantages over conventional face-to-face treatments for the behavioral dimensions of a wide range of conditions and disease states. By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity. But clinicians, payers, and other healthcare stakeholders must appreciate the rigor of the regulatory frameworks within which PDTs are approved for use.

Narrative Review: The FDA's Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events.

Background: The Food and Drug Administration (FDA) originated from the passage of the 1906 Pure Food and Drugs act aimed to rein in the long-standing abuse in the consumer product marketplace. The act was passed to prohibit interstate commerce of misbranded and adulterated foods, drinks, drugs. Thus, promoting the FDA's mission to protect the public health by regulating human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco to ensure safety, efficacy, and security. Progressing further in 1994, the Dietary Supplement Health and Education Act (DSHEA) was established designating specific label requirements, providing regulatory framework, and authorizing the FDA to promulgate good manufacturing practices for dietary supplements. This act defined and classified "dietary supplements" and "dietary ingredients" as food requiring all over the counter products (OTC) products to consist of labeling that is easy to understand and meets the FDA quality, effectiveness, and safety standards. However, under the umbrella of OTC products, the FDA fell short in its regulation of the expansive dietary supplement market. The objective of this study is to discern how the lack of efficacy in the FDA's regulations of OTC dietary supplements inevitably inspired more harm than benefit. Methods: This review comprised of case studies including young adolescents and adult consumers who experienced adverse events from the use of dietary supplements. Products which showed highest prevalence in adverse event reports through the Food and Drug Administration CFSAN Adverse Event Reporting System (CAERS) included but not limited to; Vitamin E (vitamin derivative), Beta-sitosterol (plant sterol) Yohimbine, Kava Kava Kratom, Garcinia Cambogia, (herbal products) and OxyElite Pro (marketed weight loss product). The primary endpoint was evaluating the FDA's regulations on dietary supplement safety protocols. The secondary endpoint was assessing the actions of the FDA in response to these case events. Results: Overall, between 2004 to 2021, a total of 79,071 adverse events related to the use of dietary supplements were reported to the Center for Food Safety and Applied Nutrition. Vitamin E products for example, marketed for decades for their antioxidant benefits in turn have shown significant evidence of toxicity and an increased risk of bleeding outweighing its potential benefit. The FDA's response was simply implementing a label guideline update, yet this update had evidence of minimal effect as the number of cases gradually continued to increase. Likewise, herbal products such as Kava Kava, Yohimbine, Kratom, and Garcinia Cambogia, in addition to weight regulating products, such as OxyElite Pro and HydroxyCut, have been linked to organ failure, hepatic, renal, cardiac toxicity, and death respectively. The FDA merely responded through instating public consumer warnings of their effects with consumption and limited recalls of certain products. Conclusion: With the easy accessibility of these products, the general public is more inclined to its use without proper guidance and monitoring from their healthcare team, posing as a major concern for possible interactions, contraindications and unfavorable outcomes. With proper implementation of stringent regulations post findings from increased studies on efficacy and safety, cases of adverse events could have been reduced significantly or averted completely. The FDA's minimalistic efforts consisting of only post-marketing monitoring and retrospective actions of label modifying have time and time again shown flaws as seen in the growing series of reports. By emending the over-the-counter supplement review process to reflect that of prescription medication, the magnitude of adverse events can be diminished. The process should include preclinical research in addition to clinical research, FDA thorough examination of data prior approval and post marketing surveillance.

Public Perceptions of the Food and Drug Administration's Proposed Rules Prohibiting Menthol Cigarettes on Twitter: Observational Study.

On April 28, 2022, the Food and Drug Administration (FDA) proposed rules that prohibited all menthol-flavored cigarettes and other flavored cigars to prevent the initiation of tobacco use in youth and reduce tobacco-related diseases and death. The objective of this study was to investigate public perceptions of the FDA's proposed menthol cigarette rules on Twitter. Through the Twitter streaming application programming interface, tobacco-related tweets were collected between April 28, 2022, and May 27, 2022, using a set of keywords, such as smoking, cigarette, and nicotine. Furthermore, 1941 tweets related to the FDA's proposed menthol cigarette rules were extracted. Based on 300 randomly selected example tweets, the codebook for the attitudes toward the FDA's proposed rules and related topics was developed by 2 researchers and was used to label the rest of the tweets. Among tweets related to the FDA's proposed menthol cigarette rules, 536 (27.61%) showed a positive attitude, 443 (22.82%) had a negative attitude, and 962 (49.56%) had a neutral attitude toward the proposed rules. Social justice (210/536, 39%) and health issues (117/536, 22%) were two major topics in tweets with a positive attitude. For tweets with a negative attitude, alternative tobacco or nicotine products (127/443, 29%) and racial discrimination (84/536, 16%) were two of the most popular topics. In general, the public had a positive attitude toward the FDA's proposed menthol cigarette rules. Our study provides important information to the FDA on the public perceptions of the proposed menthol cigarette rules, which will be helpful for future FDA regulations on menthol cigarettes.

Improving Drug Therapy for Pediatric Patients: Unfinished History of Pediatric Drug Development.

Improving Drug Therapy for Pediatric Patients: Unfinished History of Pediatric Drug Development.

CBD Retailers in NC Promote CBD Online to Treat Pain Violating FDA Rules About Medical Claims and Offer Low-CBD/High-Price Products.

Cannabidiol (CBD) products are available nearly nationwide in the US and can coexist with medical or recreational programs. North Carolina (NC) is an example of a state with a program dedicated to integrating hemp cultivation and medicinal CBD exclusively, containing a multitude of retailers selling it as a primary product. The Food and Drug Administration (FDA) mandates that non-FDA approved CBD products cannot be marketed using medical or health-related claims and has sent warning letters to retailers violating these terms. We aim to characterize the online content of the NC CBD market by analyzing retailers' websites to determine whether hemp/CBD shops comply with FDA regulations in terms of medical claims and analyze the claimed CBD content and price of products offered online. We randomly selected three CBD retailers from the ten most populated cities of NC. We analyzed their website content: product type, medical claims, other disclaimers, price, and CBD content. We found that edible, oral, inhalable, and topical products are offered in similar proportions. Word analysis of product description revealed that "pain" and "pain relief" were the most common medical claim, followed by inflammation and anxiety. Health claims were mostly related to wellbeing. Other attributes indicate that products are associated with pleasant flavors or sensations (ie, cool, lavender, delicious, honey, menthol), which resembles the strategies used for tobacco advertisement. Most products (61%) claimed to contain less than 1000 mg of CBD. The median price of products ranged from $15-30 per 300 mg. We found a positive correlation between CBD content and price. Our data demonstrate that the NC online CBD market does not comply with FDA regulations, primarily targets patients with pain, inflammation, or anxiety, and offers products with low CBD concentration and high prices. New policies should limit the access and online promotion of non-pharmaceutical grade CBD products.

Recommendations for inversion table therapy

In the USA, low back pain related illness accounts for approximately 149 million workdays lost each year. Initial management of back pain typically involves allied healthcare professionals who implement various treatments, such as chiropractic manipulation, physiotherapy, and acupuncture which have varying outcomes and levels of supporting evidence. Another passive treatment for back pain is inversion table therapy (ITT). It is a form of spinal traction which is thought to have a role in relieving low back pain due to the gravity-facilitated traction of the spine which distracts the lumbar vertebrae. However, ITT is not without risk. According to the Food and Drug Administration (FDA) Medical Device Reporting Events Database, ITT has resulted in serious injuries including spinal cord injury, fractures, lacerations, and death. The FDA has regulated ITT for only manufacturers that indicated medical use; however, most manufacturers have not made such medical claims and were exempt from FDA regulation. This article discusses the risks of ITT, the current regulatory process for ITT, and the need for a better understanding of the role of ITT in the treatment of spinal pain while optimizing consumer safety. Implications for rehabilitation Inversion table therapy (ITT) is a form of spinal traction which is thought to have a role in relieving low back pain due to the gravity-facilitated traction of the spine which distracts the lumbar vertebrae. According to the Food and Drug Administration (FDA) statistics, injuries due to non-powered traction from various medical devices have been rising since 2011. The FDA has regulated ITT for only manufacturers that indicated medical use; however, most manufacturers have not made such medical claims and were exempt from FDA regulation. This article discusses the risks of ITT, the current regulatory process for ITT, and the need for a better understanding of the role of ITT in the treatment of spinal pain while optimizing consumer safety.

Tobacco Product Use Among Middle and High School Students - United States, 2022.

Tobacco use* is the leading cause of preventable disease, disability, and death among adults in the United States (1). Youth use of tobacco products in any form is unsafe, and nearly all tobacco use begins during youth and young adulthood (2). The Food and Drug Administration (FDA) and CDC analyzed data from the 2022 National Youth Tobacco Survey (NYTS) to estimate current (past 30-day) use of eight tobacco products among U.S. middle (grades 6-8) and high school (grades 9-12) students. In 2022, approximately 11.3% of all students (representing 3.08 million persons) reported currently using any tobacco product, including 16.5% of high school and 4.5% of middle school students (2.51 million and 530,000 persons, respectively). Electronic cigarettes (e-cigarettes) were the most commonly used tobacco product among high school (14.1%; 2.14 million) and middle school (3.3%; 380,000) students. Approximately 3.7% of all students (representing 1 million persons) reported currently smoking any combustible tobacco product. Current use of any tobacco product was higher among certain population groups, including 13.5% of non-Hispanic American Indian or Alaska Native (AI/AN)† students; 16.0% of students identifying as lesbian, gay, or bisexual (LGB); 16.6% of students identifying as transgender; 18.3% of students reporting severe psychological distress; 12.5% of students with low family affluence; and 27.2% of students with low academic achievement. Implementation of comprehensive evidence-based tobacco control strategies, combined with FDA regulation, is important for preventing and reducing youth tobacco product use (1,2).

Comparison of Permanent Hair Removal Procedures before Gender-Affirming Vaginoplasty: Why We Should Consider Laser Hair Removal as a First-Line Treatment for Patients Who Meet Criteria.

IntroductionPermanent genital hair removal is required before gender-affirming vaginoplasty to prevent hair-related complications. No previous studies have directly compared the relative efficacy, costs, and patient experiences with laser hair removal (LHR) vs electrolysis treatments. Food and Drug Administration (FDA) oversight of medical devices is poorly understood and commonly misrepresented, adversely affecting patient care.AimThis study compares treatment outcomes of electrolysis and LHR for genital hair removal and investigates FDA regulation of electrolysis and LHR devices.MethodsPenile-inversion vaginoplasty and shallow-depth vaginoplasty patients completed surveys about their preoperative hair removal, including procedure type, number/frequency of sessions, cost, and discomfort. Publicly available FDA-review documents and databases were reviewed.Main Outcomes MeasureCompared to electrolysis, LHR was associated with greater efficiency, decreased cost, decreased pain, and improved patient satisfaction.ResultsOf 52 total (44 full-depth and 8 shallow-depth) vaginoplasty patients, 22 of 52 underwent electrolysis only, 15 of 52 underwent laser only, and 15 of 52 used both techniques. Compared to patients that underwent LHR only, patients that underwent only electrolysis required a significantly greater number of treatment sessions (mean 24.3 electrolysis vs 8.1 LHR sessions, P < .01) and more frequent sessions (every 2.4 weeks for electrolysis vs 5.3 weeks for LHR, P < .01) to complete treatment (defined as absence of re-growth over 2 months). Electrolysis sessions were significantly longer than LHR sessions (152 minutes vs 26 minutes, P < .01). Total treatment costs for electrolysis ($5,161) were significantly greater than for laser ($981, P < .01). Electrolysis was associated with greater pain and significantly increased need for pretreatment analgesia, which further contributed to higher net costs for treatment with electrolysis vs laser. Many LHR and electrolysis devices have been FDA-cleared for safety, but the FDA does not assess or compare clinical efficacy or efficiency.Clinical ImplicationsFor patients with dark-pigmented hair, providers should consider LHR as the first-line treatment option for preoperative hair removal before gender-affirming vaginoplasty.Strength and LimitationsThis is the first study to compare electrolysis and LHR for genital hair removal. The discussion addresses FDA review/oversight of devices, which is commonly misrepresented. Limitations include the survey format for data collection.ConclusionWhen compared with electrolysis, LHR showed greater treatment efficiency (shorter and fewer treatment sessions to complete treatment), less pain, greater tolerability, and lower total cost. Our data suggests that, for patients with dark genital hair, providers should consider recommending laser as the first-line treatment for permanent genital hair removal before vaginoplasty.Yuan N, Feldman A, Chin P, et al. Comparison of Permanent Hair Removal Procedures before Gender-Affirming Vaginoplasty: Why We Should Consider Laser Hair Removal as a First-Line Treatment for Patients Who Meet Criteria. Sex Med 2022;10:100545.

Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try.

For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.