China
Africa
Explore chapters and articles related to this topic
Nutraceuticals and Functional Foods
Published in Robert E.C. Wildman, Richard S. Bruno, Handbook of Nutraceuticals and Functional Foods, 2019
The potential functions of nutraceutical/functional food ingredients are so often related to the maintenance or improvement of health that it is necessary to distinguish between a food ingredient that has function and a drug. The core definition of a drug is any article that is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” (21 U.S.C. 321(g)(1)(B)). At the same time, certain health claims can be made for foods and ingredients that are associated with health conditions.11 In the U.S., such health claims are defined and regulated by the U.S. Food and Drug Administration (FDA). Health claims related to foods and ingredients include an implied or explicit statement about the relationship of a food substance to a disease or health-related condition (21 U.S.C.343(r)(1)(B) and 21 C.F.R.101.14(a)(1)). The major categories of health claims are listed in Table 1.1 with examples of each.
The Concept of Nutritional Status and Its Measurement
Published in James M. Rippe, Lifestyle Medicine, 2019
Johanna T. Dwyer, Regan L. Bailey
Two major types of health claims exist: health claims that meet “significant scientific agreement” and “qualified health claims.” Health claims are graded by the FDA on the quality and amount of the scientific evidence provided to support the claim. The claims are not endorsed by the FDA below the level of an A rating (an A meaning the claim has strong scientific agreement). There currently are only 12 approved health claims that meet significant scientific agreement. These include claims about the role of nutrients and foods on health and disease. For example, a claim regarding folic acid and neural tube defects might be worded as follows: “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.” This statement is allowed on packages of food containing 100% or less of the DV for folate.
Nutritional and Alternative Medicine
Published in Aruna Bakhru, Nutrition and Integrative Medicine, 2018
In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA). Part of that legislation allowed for “health claims” in association with foods. The DSHEA expanded those provisions to dietary supplements in 1993. A “health claim” is a claim made on the label or in labeling of a food or supplement that expressly or by implication characterizes the relationship of any substance to a disease or health-related condition. Health claims are limited to claims concerning disease risk-reduction. In other words, health claims focus on disease prevention. A health claim cannot include language purported to diagnose, cure, mitigate, or treat disease. Under the NLEA, the FDA must preapprove any claim before it enters the market. Those limitations apply to all commercial statements concerning dietary supplements or foods. The failure to obtain FDA preapproval for a health claim would render any product bearing such a claim an “unapproved new drug.”
Participant perspectives on a phase I/II ocular gene therapy trial (NCT02077361)
Published in Ophthalmic Genetics, 2019
Stephanie P. Brooks, Shelly Benjaminy, Tania Bubela
The participants in our study appreciated a balanced communication approach during the informed consent process. However, the use of 6-month safety data from the Oxford University CHM gene therapy trial (NCT01461213) gave the impression that the intervention had already proven safe and efficacious, which influenced participation decisions. Our trial offered the only available six-month safety data on record at the time of enrollment. Its information sheet only presented the lack of adverse events in the Oxford trial, but trial staff discussed the associated preliminary publication, which emphasized early signs of benefit in two patients (14). This preliminary study, published in The Lancet, received widespread media coverage, and participants accessed and accounted for these published results in their decisions to enroll in the Canadian trial. The considerable media coverage of the Oxford trial, like other coverage of biomedical research, highlighted benefits and failed to adequately report the risks of clinical research (12,19–22). Such exaggerated or unfounded health claims in the media may impact patient perceptions of the immediacy and magnitude of benefits of investigational products (33,12,22–24). Our study therefore highlights (1) the ethical imperative to publish clinical trial results, because these inform not only the scientific community, but also future clinical trial participation and (2) the need for clinical trial staff to support potential participants in their interpretation of the risks and benefits identified in prior studies.
Is it time to be concerned about the effects of e-cigarettes on cardiovascular health?
Published in Expert Review of Cardiovascular Therapy, 2018
Giuseppe Lippi, Fabian Sanchis-Gomar
According to the World Health Organization (WHO), an e-cigarette (also called electronic nicotine delivery system; ENDS) is defined as a device which does not directly burn tobacco, but vaporizes a solution which can then be inhaled by the user [1]. The leading components of this solution usually include nicotine, propylene glycol, vegetable glycerin, and flavoring agents. Recent statistics attests that the global worldwide market of ENDSs amounted to approximately 11.5 billion US$ in 2016, but is predicted to undergo a double-digit growth up to 2025, with up to 30% of current cigarette smokers predicted to shift to using e-cigarettes [2]. These notable figures prompt many international, national healthcare and consumer organizations to raise safety issues about the possible harm caused by ENDSs use. Among these, the WHO has recently endorsed a number of official warnings aimed to: (i) prevent initiation of ENDS and/or electronic non-nicotine delivery systems use among nonsmokers, young people, and vulnerable groups; (ii) minimize health risks associated with the use of ENDS; (iii) prevent unconfirmed health claims made about ENDS; and (iv) protect people from particular interests connected with ENDS industry [1]. Regardless of these straightforward advices, it may be useful to briefly summarize here the recent scientific evidence on the potential impact of ENDSs on cardiovascular health. Although the research is still rudimentary due to the relatively recent commercialization of ENDSs, some preliminary findings have been published.
The cannabis conundrum: steering policy and medicine with insufficient data
Published in International Review of Psychiatry, 2018
The allowance of cannabis to be used as a medicine in the absence of adequate data to inform basic clinical decision-making is rooted in compassion for individuals with life-threatening illness, or substantially debilitating illness, and no other course for treatment. However, this relatively simple tenet has now morphed into a large-scale for-profit industry that is fraught with public health concerns. Access to cannabis has been expanded to include treatment for a multitude of health conditions, many of which are neither life-threatening nor debilitating, and for which effective alternative treatments exist. Data from which to determine the risk-benefit for an individual considering the use of cannabis is sparse at best. Quality control issues abound in this industry as there are no established standards for cultivating, processing, testing, or labeling cannabis products. There is also concern over advertisements and product labeling that include misleading or unsubstantiated health claims, as these products have not been vetted by traditional drug development methods. The speed in which cannabis policies are changing is rapid, and the fact that these are happening as a direct result of legislation or by voter referendum is reckless given the absence of consensus standards and, in many cases, appropriate regulatory oversight. The impact of revised cannabis laws, both with respect to medicinal use for a variety of health conditions, and for non-medicinal (aka ‘recreational’) use of cannabis by adults, will likely have a substantial impact on psychiatry.