视角:个性化营养在当前美国监管框架中的挑战和未来的机遇
Sharon M Donovan1, Mariette Abrahams2, Joshua C Anthony3
1Department of Food Science and Human Nutrition, and Personalized Nutrition Initiative, Carl R. Woese Institute for Genomic Biology, University of Illinois Urbana-Champaign, Urbana, IL, United States.
Advances in nutrition (Bethesda, Md.)
|January 26, 2025
概括
个性化营养 (PN) 使用新技术提供量身定制的健康建议,但需要更新安全,隐私和清晰沟通的规定. 未来的创新取决于调整当前的美国监管框架.
科学领域:
- 营养科学 营养科学
- 监管科学 监管科学
- 医疗卫生技术 技术 技术
背景情况:
- 个性化营养 (PN) 集成个人数据,以提供量身定制的饮食建议和行为改变.
- 技术进步,如可穿戴设备,人工智能和新的生物标志物正在迅速发展PN领域.
- 目前的PN计划引起了人们对用户安全,隐私和监管监督的担忧.
研究的目的:
- 解决当前个性化营养计划的监管影响.
- 在现有的美国监管框架内探索未来的创新机会.
- 检查各种PN组件的监督的复杂性.
主要方法:
- 一个研讨会召集了专家,讨论了个性化营养调节的挑战和机遇.
- 在PN中分析食品,补充剂,诊断和设备的监管方面.
- 讨论适应新兴PN技术的监管框架.
主要成果:
- PN计划往往结合了多个组件,需要不同的监管方法.
- 监管指导的关键领域包括测试/设备准确性,专家认证,明确的沟通,索赔证明和隐私保护.
- 适应现有的监管框架对于整合人工智能和机器学习等新技术至关重要.
结论:
- 对PN的监管指导必须优先考虑用户安全,数据隐私和科学有效性.
- 与监管机构的合作对于个性化营养的透明度,信任和创新至关重要.
- 随着PN的不断变化的性质,需要一种适应性和全面的监管方法.
相关概念视频
Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K
Drug Control Governance: Regulatory Bodies and Their Impact
138
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
138
Cancer Prevention
6.0K
Several factors can increase the risk of cancer in an individual. About 50% of cancer cases can be prevented by adopting a healthy lifestyle, regular exercise, eating healthy, and following a modest cancer prevention diet. Epidemiological studies have consistently shown that populations with vegetable and fruit-rich diets have reduced the incidence of cancer. On the other hand, populations who have a diet rich in animal fat, red meat, junk food, or high calories are predisposed to cancer.
Some...
Some...
6.0K
Regulation of Food Intake
182
Short-term regulation of food intake primarily involves neural signals from the gastrointestinal (GI) tract, blood nutrient levels, and GI tract hormones. Communication between the gut and brain via vagal nerve fibers plays a significant role in evaluating the contents of the gut. Clinical studies have shown that protein ingestion produces a more prolonged response in these nerve fibers compared to an equivalent amount of glucose. Additionally, the activation of stretch receptors caused by GI...
182
Key Elements for Plant Nutrition
18.6K
Like all living organisms, plants require organic and inorganic nutrients to survive, reproduce, grow and maintain homeostasis. To identify nutrients that are essential for plant functioning, researchers have leveraged a technique called hydroponics. In hydroponic culture systems, plants are grown—without soil—in water-based solutions containing nutrients. At least 17 nutrients have been identified as essential elements required by plants. Plants acquire these elements from the...
18.6K
Prescription, Nonprescription and Orphan Drugs
683
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
683


