FDA Questions Health Claims;Agency Sends Warning Letters to 6 FirmsMargie G. Quimpo
2024年3月1日,美国食品药品监督管理局(FDA)在一封执法自由裁量书中宣布,FDA不反对某些食品厂家有关酸奶降低2型糖尿病风险的合格健康声明,前提是措辞不会误导消费者,并且符合使用该声明的其他因素。 换言之,美国FDA在一定程度上认可了酸奶降低2型糖...
Based on these claims, the products listed are intended for prevention of disease (e.g., “protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matter”) and are therefore devices within the meaning of the Act.1 基于这些声明,所列产品旨...
This collaboration between online information and professional healthcare services contributes to a more informed and engaged patient population. The inclination to seek health information online reflects the evolving landscape of healthcare in the digital age. The accessibility, empowerment through knowledge,...
− Electronic health record (EHR) data − Medical claims data − Product or disease registry data − Data obtained from digital health technologies − Data gathered from other sources that can inform on health status, such as questionnaires ...
Examples include: − Electronic health record (EHR) data − Medical claims data − Product or disease registry data − Data obtained from digital health technologies − Data gathered from other sources that can inform on health status, such as questionnaires 1 This guidance has been ...
Examples of claims observed on the MISSY KAY Premium Hand Sanitizer product label and labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following: 在MISSY KAY洗手液产品标签上观察到的声明示例,以及提供产品...
Jenny claims that the medicine has had no significant negative effects on her. There was signs of some very minor bleeding in the brain at one point, which was quite some time ago. It was at very low levels, in fact, Joe expressed concern about Jenny, but added that the physicians were...
structure/function claims disease claims health claims and qualified health claims nutrient content claims. Basically, dietary supplements cannot make 'disease' claims (for example: 'this supplement shrinks tumors'). Dietary supplements that make disease claims will be regulated by the FDA as drugs. ...
19 was “ethnically targeted” to spare Ashkenazi Jews and the Chinese. He has stated that ivermectin and hydroxychloroquine are effective COVID treatments, notwithstanding evidence to the contrary. Washington Post,10 RFK Jr. conspiracy theories and false claims, in his own words, Nov. 15, 2024....