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.

A new perspective on the pharmacoeconomics of colchicine.

BACKGROUND: Gout is a common inflammatory arthritis that affects ∼4% of the US population. Most patients with gout are >50 years of age and have multiple comorbidities. Gout is caused by the deposition of monosodium urate crystals in joints secondary to hyperuricemia. Gout typically presents as an acute painful inflammation (flare) involving one or more joint. Left untreated it can progress into a more chronic polyarthritis. Acute gout flare treatment options include colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), and corticosteroids. The safety and efficacy of colchicine, especially in the presence of comorbidity and potential contraindications, has only recently been systematically investigated. METHODS: Through the use of a systematic computer-based literature analysis, this pharmacoeconomic review evaluated costs, risks, and benefits of Colcrys (colchicine) compared with other treatments for gout in the US. RESULTS: Both colchicine and NSAIDs are historically associated with gastrointestinal (GI) adverse events (AEs). Colchicine has very low risk for AEs, even in patients with GI disorders; whereas, NSAIDS are contraindicated in patients with GI disorders, renal insufficiency, and heart failure. The monthly cost of treating 100 patients with Colcrys was $33,100 compared with $3000 for NSAIDs. However, hospitalization for GI complications (1.8%) and heart failure (1.9%) is common with NSAIDs and can increase the monthly cost of treating 100 patients with NSAIDs to $161,000, considering $15,000-20,000 per day of hospitalization. CONCLUSIONS: Considering high costs associated with treating patients with gout, it seems prudent to choose the treatment with greatest benefit, lowest cost, and least risk. Despite higher cost per dose, colchicine appears to be more cost effective for management of gout flares than NSAIDs.

Dietary supplement use among academic pharmacists

United States sales of dietary supplements exceeded $18 billion in 2002, indicating that dietary supplement use is common among the American public. This report describes a survey of academic pharmacists and their use of dietary supplements and herbs. To date, most data comes from retail or community pharmacists, so a survey was developed to collect information regarding dietary supplement and herb usage from academic pharmacists. Academic pharmacists are probably the most knowledgeable group in regards to assessing the clinical value of supplements. Our results showed that 54% of academic pharmacists have used dietary supplements or herbs. However, it is interesting to note that most of the dietary supplements listed were not in the top ten most commonly used supplements. In addition, there was no excessive use of supplements or herbs by this group of pharmacists since the majority of respondents listed multivitamins (AU)

Las ventas en Estados Unidos de suplementos dietéticos superan los 18.000 millones de dólares, lo que indica que el use de suplementos dietéticas es común entre el público americano. Este informe describe una encuesta a farmacéuticos académicos y su uso de suplementos dietéticas y plantas medicinales. Hasta la fecha, la mayoría de los datos vienen de farmacias comunitarias o de detallistas, por lo que se desarrolló una encuesta para recoger información sobre el uso de suplementos dietéticas y plantas medicinales por los farmacéuticos académicos. Los farmacéuticos académicos son probablemente el grupo más reconocido para evaluar el valor clínico de los suplementos. Nuestros resultados muestran que el 54% de los farmacéuticos académicos ha usado suplementos dietéticos o plantas medicinales. Sin embargo, es interesante referir que la mayoría de los suplementos dietéticas listados no aparecen entre los 10 más comúnmente utilizados. Además, no hubo excesiva utilización de suplementos o plantas medicinales en este grupo de farmacéuticos ya que la mayoría de los respondentes relató multi-vitamínicos (AU)

Dietary supplement use among academic pharmacists.

United States sales of dietary supplements exceeded $18 billion in 2002, indicating that dietary supplement use is common among the American public. This report describes a survey of academic pharmacists and their use of dietary supplements and herbs. To date, most data comes from retail or community pharmacists, so a survey was developed to collect information regarding dietary supplement and herb usage from academic pharmacists. Academic pharmacists are probably the most knowledgeable group in regards to assessing the clinical value of supplements. Our results showed that 54% of academic pharmacists have used dietary supplements or herbs. However, it is interesting to note that most of the dietary supplements listed were not in the top ten most commonly used supplements. In addition, there was no excessive use of supplements or herbs by this group of pharmacists since the majority of respondents listed multivitamins.