Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[LutherTiggs]

Response from FDA to my inquiry:

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC) has prepared a response for case number xxxxx.




Response:



Thank you for taking the time to contact the U.S. Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN). I am able to provide you with information available at www.fda.gov that will direct you to the resources, guidance and regulations that will assist you in determining how to apply them to your unique product, circumstance, question or concern.



You may find it beneficial to review all of the information provided about dietary supplements.



For information related to Anatabloc, you will have to contact the manufacturer directly.



Dietary supplements are not FDA approved, as FDA does not approve or test dietary supplements or their ingredients for safety or effectiveness before they are marketed nor does the agency conduct testing at the requests of consumers. However, the agency has the authority take dietary supplements off the market if they are found to be unsafe, adulterated, or if the claims on the products are false and misleading.



The Federal Food, Drug, and Cosmetic Act (FD&C Act), requires manufacturers to ensure that their products are safe and properly labeled. Properly labeled includes labeling that is truthful and not misleading, which provides ingredient and nutritional information.



To learn more about FDA please visit: Center for Food Safety and Applied Nutrition (CFSAN), Contact FDA, Submit Questions and Comments, Print Publications, Is It Really FDA Approved?, What does FDA Do? and What doesn’t FDA regulate? How do I contact the agencies that do.


Thank you for contacting FDA’s FCIC.




**Please do not reply to this email box. If you would like to submit a follow-up question or need clarification to this inquiry, please click here http://cfsan.force.com/Inquirypage and reference this inquiry’s case number.