January 21, 2020. We strongly oppose the approval of the modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.” This claim may encourage non-smokers to begin using tobacco. Using smokeless tobacco increases the risk of serious health issues.
Read More »Tag: FDA regulation
How Safe are Dietary Supplements?
In their quest for health and beauty, many American adults take dietary supplements to solve all sorts of problems. But do these products really work, and are they safe? Many aren’t. Don’t trust the claims that companies make about either the effectiveness or safety of their products. Even brand name products may not contain what they say they contain, so let the buyer beware.
Read More »NCHR Comments on Modernizing FDA’s 510(k) Program
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
Read More »Trying to Get Pregnant or Trying to Avoid it? Now, There Are Apps for Both!
Digital birth control apps are becoming more common. The FDA has now cleared two apps: Natural Cycles and Clue for preventing pregnancy. Read more about why these apps are unreliable for women looking to avoid pregnancy.
Read More »NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data
March 21, 2019. Patient perspectives and experience are important considerations for medical product development and regulation. Patients, caregivers, and patient and consumer groups can provide a valuable resource for product developers and the FDA. Transparency in how the FDA evaluates and uses proposed draft guidances as well as who and how they are developed will be important if they are to provide meaningful and accurate information about patients.
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