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Traditional Medicines for Mental Health
Published in Abhai Kumar, Debasis Bagchi, Antioxidants and Functional Foods for Neurodegenerative Disorders, 2021
Smita Singh, Anup Singh, Abhai Kumar, Rameshwar Nath Chaurasia
The global acceptance of the traditional or complementary alternative medicines is increasing nowadays; still the regulation and legal status vary from country to country. In the United States, the herbal medicines are regulated by Center for Food Safety and Applied Nutrition, an agency Food and Drug Administration (FDA) under dietary supplement category (Swann, 2016). Another NIH agency National Center for Complementary and Alternative Medicine is dedicated to develop an understanding of dietary supplements by evaluating scientific information, supporting research based on complementary and alternative medicines, and strengthening and disseminating the knowledge for improving health care. The source, manufacturing, quality control, dispensation, and permission to administer treatments are key question which needs to be answered in a regulated manner. The standard of application of traditional medicines could also vary so as the performance from one place to other depending upon the indigenous region, culture, faith, environmental changes, and other external factors (WHO, 2001). The countries such as India and China face the same challenges of having few evidence-based research and dose-specific reports for indigenous traditional medicines and therapies. A study conducted on paper The Lancet and Lancet Psychiatry’s Series about the China–India Mental Health Alliance shows the complications and makes the effectiveness of traditional medicine lucid.
Champion Microalgal Forms for Food and Health Applications
Published in Gokare A. Ravishankar, Ranga Rao Ambati, Handbook of Algal Technologies and Phytochemicals, 2019
Chiara Toniolo, Marcello Nicoletti, Paola Del Serrone, Ambati Ranga Rao, Gokare A. Ravishankar
For the FDA, any substance which has been added intentionally to food is a food additive and is subject to premarket review and approval by the FDA, except when the substance is generally recognized, among qualified experts, as safe (GRAS) under the conditions of its intended use. As per the center for food safety and applied nutrition, Spirulina, Dunaliella, Schizochytrium, P. cruentum Chlorella are used as food sources falling under Generally Recognized As Safe (GRAS). Some other algal products granted GRAS status are oils from Schyzochitrium and Ulkenia, whole algal protein powder, and a lipid ingredient derived from Chlorella (FDA, 2010).
Testing for Reproductive Hazards from Dermal Exposure
Published in Francis N. Marzulli, Howard I. Maibach, Dermatotoxicology Methods: The Laboratory Worker’s Vade Mecum, 2019
For cosmetic components, the Food and Drug Administration (FDA) guidelines in the Center for Food Safety and Applied Nutrition (CFSAN) Redbook (US FDA, 1993) should be followed for color additives, but this testing is not required for other ingredients. Both developmental toxicity and multigeneration reproduction tests are described in the Redbook.
Haff disease associated with consumption of buffalofish (Ictiobus spp.) in the United States, 2010–2020, with confirmation of the causative species
Published in Clinical Toxicology, 2022
Jonathan R. Deeds, Robert A. Literman, Sara M. Handy, Karl C. Klontz, Karen A. Swajian, Ronald A. Benner, Henry L. Bart
Upon initial interview, patients were asked if meal remnants, defined as any remaining edible portion, cooked or uncooked, from the exact fish consumed from the illness event, were available and if so were asked to freeze the sample for pick up by either state or FDA personnel. In some cases, state or local health agencies collected additional associated samples, defined as whole fish or fish portions from the same commercial lot as the fish that caused illness, from retail. All samples were transferred frozen to the FDA Center for Food Safety and Applied Nutrition and stored frozen at −80 °C until analysis. When possible, traceback analysis was performed to determine the original harvest location of all collected samples.
On healthcare by popular appeal: critical assessment of benefit and risk in cannabidiol based dietary supplements
Published in Expert Review of Clinical Pharmacology, 2019
It is fair to ponder just how many adverse events would be reported regarding CBD were there a robust system in place to collect such data. The FDA Center for Food Safety and Applied Nutrition (CFSAN) houses an Adverse Events Reporting System (CAERS) through which reports of injury due to dietary supplements are logged [12]. While CBD is not recognized federally as a dietary supplement and thus data on it are not reliably captured by CAERS, pertinent observations have been made regarding the system which speak to the importance of obligatory federal regulation of ingested supplements. The Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) was passed in 2006, partly in response to the supplement industry intentionally suppressing roughly 14,000 reports of adverse events during hearings regarding the safety of ephedrine [87]. Before passage of this act, CAERS only collected data on dietary supplement adverse effects through voluntary reporting, primarily from consumers and health-care providers. Between 2004 and 2013, such voluntary reporting yielded an average of 552 annual cases (4972 over nine years) of suspected harm due to the ingestion of dietary supplements [88]. In 2007, the DSNDCPA implemented new mandatory reporting guidelines by which supplement manufacturers and distributers would be obliged to report to CAERS all serious adverse events brought to their attention, with ‘serious adverse events’ being defined as those requiring medical intervention to prevent serious injury or death. Due to this change in reporting requirements, 10,327 mandatory reports of serious events were received between 2007 and 2013, a 6-year span which yielded more than double the number of voluntary reports seen over the inclusive nine years. Further assessment of the CAERS data suggests that such reporting represents only 2% of the total number of dietary supplement adverse events based on an estimated 23,000 annual emergency room visits attributed to the use of dietary supplements. Once again, such outcomes make clear the risk of presuming safety based on the absence of meaningful data that is only identified through its active collection.