June 14, 2019 Update:
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.
For more information about this seizure, please read the FDA press release.
The FDA is advising consumers not to use certain Life Rising dietary supplements because they may be contaminated with lead. These supplements were sold mostly in the Chicago area at HoliCare clinics and in limited quantity through mail order.
Samples of the following products tested positive for lead during FDA testing:
- Holder-W Holder Warmer
- Metabolism Cleansing (MET-CLS)
- Neck-ND Neck Clear
The FDA recently sampled and tested targeted dietary supplement products as part of a follow-up inspection to a previous company recall involving lead contamination and a related Warning Letter issued to the company in 2017. The FDA notified the company, Life Rising Corporation, that their products were contaminated with lead and the company has agreed to issue a voluntary recall.
Lead is a naturally occurring heavy metal found in the environment and is poisonous to humans. Lead can contaminate foods through contact with the growing environment, in the case of raw ingredients, or through the manufacturing process. Exposure to lead can result in serious health risks. Lead affects people of any age or health status and can be especially harmful to vulnerable populations including infants, young children, pregnant women and their fetuses, and others with chronic health conditions.
Exposure to lead can result in harm to the organs, brain, and nervous system. Lead poisoning can be diagnosed through clinical testing.
Consumers who have these brands of Rising Life dietary supplements in their home should stop using them and return them to the retailer for a full refund. Contact information for the retailer can be found in their recall announcement.
Consumers who believe they are experiencing symptoms of lead poisoning should call a medical professional. Health care professionals and consumers are also encouraged to report any adverse events potentially related to Life Rising dietary supplements to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178
The FDA is advising consumers not to use any of the following products:
- Neck-ND Neck Clear – clear capsules
- Holder-W Holder Warmer – tablets
- Metabolism Cleansing (MET-CLS) – clear capsules