06/11/2019

06/04/2019

Spectrum Laboratory Products

Division of Pharmaceutical Quality Operations IV

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

FDA is Committed to Sound, Science-based Policy on CBD

Science forms the basis for decisions at the U.S. Food and Drug Administration (FDA) and is paramount when it comes to making decisions that will impact the health and safety of the American public. We apply this rigorous, science-based approach to matters large and small that come before the Agency – including with respect to products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD). We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise. At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.

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Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than 300,000 containers of dietary supplements, including tablets, capsules, and teas from Life Rising Corporation. The seized goods, which were held by Life Rising or manufactured in the company’s facility located in Willowbrook, Ill., consisted of more than 500 products bearing brand names Life Rising, Holicare, or HopeStream, and are valued at approximately $3.5 million. The U.S. District Court for the Northern District of Illinois determined there was probable cause that the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements.    “This seizure underscores the agency’s commitment to taking aggressive action when manufacturers distribute adulterated dietary supplements that have the potential to ...

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