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A Sampling of CAM Therapies and Philosophies
Published in Lillian R. Brazin, The Guide to Complementary and Alternative Medicine on the Internet, 2020
GRAS is a compilation of all botanicals appearing on the Food and Drug Administration’s list of food additives generally recognized as safe by a consensus of scientific opinion. Read the introduction, which explains why some herbal products are safe, even though they might not appear on the GRAS list. GRAS is excerpted from the Code of Federal Regulations (CFR Title 21, Parts 172, 182, 184, and 186). Henriette’s Herbal Homepage<http://www.ibiblio.org/herbmed/index.html>
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).
Food Additives
Published in Dongyou Liu, Handbook of Foodborne Diseases, 2018
For a substance other than those considered as “prior-sanctioned substances” or GRAS to be approved for use in food preparation, a manufacturer or sponsor must provide evidence that the substance is safe for the ways in which it is to be used (e.g., maximum concentrations recommended) [2]. However, existence of a 5% loophole (i.e., if an ingredient makes up <5% of the complete food product, it does not have to be listed) may potentially compromise the integrity of the regulation system specifically designed for food additives [4].
Patho-physiological and toxicological aspects of monosodium glutamate
Published in Toxicology Mechanisms and Methods, 2019
In the United States, the GRAS concept is one way in which the regulatory authority to use a food ingredient (other than color additives) can be determined with the other key path being through an application to the Food and Drug Administration for food additive status. GRAS status may be achieved either through the FDA’s voluntary GRAS notification program (FDA 1997) or through a properly conducted GRAS determination made by a private party. Over the years, FDA has received reports of symptoms such as headache and nausea after eating foods containing MSG. These adverse event reports helped trigger FDA to ask the independent scientific group Federation of American Societies for Experimental Biology (FASEB) to examine the safety of MSG in the 1990s. FASEB’s report concluded that MSG is safe. The FASEB report identified some short-term, transient, and generally mild symptoms, such as headache, numbness, flushing, tingling, palpitations, and drowsiness that may occur in some sensitive individuals who consume 3 g or more of MSG without food. However, a typical serving of a food with added MSG contains less than 0.5 g of MSG. Consuming more than 3 g of MSG without food at one time is unlikely (Kazmi et al. 2017).
Therapeutic challenges in ocular delivery of lipid based emulsion
Published in Egyptian Journal of Basic and Applied Sciences, 2018
Rahul Tiwari, Vikas Pandey, Saket Asati, Vandana Soni, Dharmendra Jain
Safety considerations of any formulations intended for the cure or diagnosis of diseases or other conditions should be considered to be absolutely essential in formulations development. Safety assessment and potential consequences of different biopharmaceutical factors on the drug or lipid excipients and their interaction should be explored. Though, it becomes difficult to correlate in vitro results obtained through conventional dissolution methods for predicting the in vivo performance of a lipid based dosage form [73]. The lack of proper certainty for product quality and its performance may be caused by nature of empirical and irrelative processes traditionally used. So, only the product which has been considered generally recognized as safe (GRAS) by the FDA should be used. As all excipients (Table A2) are not inert substances, and may results in some unwanted and toxic features at higher concentrations. One of the most important and crucial aspect of any topical ophthalmic formulation is to examine non-irritant property which should shows the ocular tolerance on instillation into eye. In vitro, ex vivo, and in vivo evaluations should be done on both drug and drug bearing ocular LEs [74].The parameters discussed below needs to be considered well thoughtout the design and development of the ocular lipid based preparations (Table A3).
3D printing for enhanced drug delivery: current state-of-the-art and challenges
Published in Drug Development and Industrial Pharmacy, 2020
Melissa Wallis, Zaisam Al-Dulimi, Deck Khong Tan, Mohammed Maniruzzaman, Ali Nokhodchi
It should be noted that parameters to be considered when designing a safe dosage form for 3D printing are entirely dependent on the type of 3D printing technique being used, hence there is not one official guideline as there is a wide range of 3D printing technique which are very different. In general, the materials that are used must be Generally Recognized As Safe (GRAS) by the FDA to ensure the safety of the dosage forms. The design of dosage forms is still required to comply with the current Good Manufacturing Practice (GMP) regulations, as with other pharmaceutical manufacturing processes. The use of any toxic solvents should be avoided, and the printing temperature should not be too high to prevent any thermal degradation of the pharmaceutical products.