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The Non-Prescription Products – Market-Profits and Public Health in Conflict
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
After the deadline expired, Panel deliberations began. Panels looked at the manufacturer-submitted data and gathered all available information from the published literature. Panels carried out an exhaustive examination of the available data to determine whether existing research was carried out in a proper manner, for example, appropriate sample sizes, correct statistical tests. Each ingredient was assigned to one of three categories: Category I – Sufficient evidence exists that the ingredient is safe and effective. The legal term for these ingredients is GRASE (generally recognized as safe and effective).Category II – Sufficient evidence exists that the ingredient is unsafe or ineffective, or both.Category III – There is insufficient evidence to judge the safety and/or efficacy of the ingredient.
The FDA New Animal Drug Approval Process
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
Jacob Michael Froehlich, Alice Ignaszewski, Anna O’Brien
Similarly, the Act defines the term “new animal drug” as “any drug intended for use for animals other than man” that is not generally recognized as safe and effective “for use under the conditions prescribed, recommended, or suggested in the labeling.”† Here, the word “new” does not necessarily mean novel to science or medicine, but that the product is not commonly recognized as safe and effective within the literature and scientific community. While new animal drugs and human drugs are both covered by the same Act, they are reviewed by different Centers within the FDA and fall under different regulations. However, both human and animal drugs are held to similar standards.
Unitetd States
Published in Rowena K. Richter, Herbal Medicine, 2013
Many botanicals and other products that were marketed before 1938 had been grandfathered into the FDC Act of 1938 under the Pure Food and Drugs Act of 1906, and therefore had previously been exempt from proving safety and efficacy. Since the OTC review in 1972, botanicals cannot be marketed as OTC drugs unless they qualify as either “old drugs” or “new drugs.” In either case, the botanical must be generally recognized as safe and effective (GRASE) in accordance with the OTC monographs. In addition, old drugs must have been marketed in the United States to a material extent and for a material time; until January 2002, foreign marketing experience was not considered. New drugs must have an approved NDA. Few botanicals have retained their OTC status as old drugs* and so far none have been approved as new drugs through an NDA.14 As discussed later in this chapter, difficulties with patenting, multiple active ingredients, and the exclusion of foreign (particularly European) market experience from material extent and material time have all played a role in limiting the number of botanicals approved as OTC drugs in the United States to date.
Cosmetic skin lightening use and side effects
Published in Journal of Dermatological Treatment, 2022
Natasha Masub, Amor Khachemoune
Hydroquinone remains very popular outside the United States for cosmetic skin lightening (44). Thus it is imperative that dermatologists are aware that their ethnic patients may be using this product, especially because many patients are unaware of potential side effects (45). Dermatologists should counsel patients on the risks of prolonged hydroquinone therapy, particularly the risk of exogenous ochronosis. Furthermore, as hydroquinone can rapidly oxidize and deactivate, patients should be advised to discard any discolored product (color change from white to yellow or brown). Due to concerns over these side effects, hydroquinone-containing products have been banned in the EU and Japan. In the US, hydroquinone has not been officially regulated by the Food and Drug Administration (FDA). In 2006, the FDA challenged the status of over-the-counter (OTC) 2% hydroquinone as generally recognized as safe and effective due to the risk of exogenous ochronosis (46).
Is Bioequivalence a Sufficient Measure of Equivalence?
Published in Journal of Legal Medicine, 2019
“Any drug … not generally recognized … as safe and effective”1 is considered a “new drug” (“brand name”) and subjected to extensive review by the U.S. Food and Drug Administration (FDA) before its manufacturer may market it to the public.2 Generic drugs, which are “identical—or bioequivalent—to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use,” are subject to a less extensive review process and must prove only that the generic drug is the “bioequivalent” (BE) of the brand drug.3 Generic drugs generally cost 80% to 85% less than brand drugs and comprise almost 80% of prescriptions filled in the United States today.4
Dispelling myths about sunscreen
Published in Journal of Dermatological Treatment, 2022
Sabrina Lichon Bennett, Amor Khachemoune
The U.S. FDA regulates sunscreen products and classifies them as over-the-counter drugs. In 2019, FDA proposed a new rule describing which sunscreen ingredients are generally recognized as safe and effective (GRASE) (41). The two ingredients found in physical sunscreens, titanium dioxide and zinc oxide, are currently classified as GRASE as studies have shown them to be safe and not systemically absorbed (41–43). Two ingredients that are not GRASE include PABA and tolamine salicylate, which you cannot find in any sunscreen sold in the United States (3,42). Some ingredients found in chemical sunscreens do not have sufficient data yet to determine their GRASE classification, and the proposed rule asks for more data to be provided to the FDA before ruling on their GRASE classification (41). Since the proposed rule, there have been two studies looking at the systemic absorption of certain chemical sunscreens (44–45). The first study looked at the systemic levels of four chemical UV filters (avobenzone, oxybenzone, octocrylene, and ecamsule) after maximal use conditions (application four times a day), while the second study looked at systemic levels of seven chemical UV filters (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate) after single application. Both studies found systemic levels of these UV filters exceeded the FDA threshold for safety testing (plasma concentration >0.05 ng/mL) under both protocols (44–45). While these ingredients are systemically absorbed, the FDA has not ruled these ingredients unsafe and does not explicitly say to stop using sunscreens with these ingredients as there is not enough data on the health effects of these ingredients (3). If individuals are concerned about the possible health effects of these ingredients, we recommend choosing physical sunscreen as the current studies show them to be safe (38–39).