December 3, 2021
- Consumers who have purchased Fulvic Care Powder and Tablets from Black Oxygen Organics should immediately stop using the products themselves, other household members or pets and throw them away.
- Products: Fulvic Care Powder and Tablets from Black Oxygen Organics
- Distribution Information: Sold online at www.blackoxygenorganics.com
The United States Food and Drug Administration (FDA) is advising consumers to not use Fulvic Care Powder and Tablets from Black Oxygen Organics or give the products to pets due to elevated levels of lead and arsenic. Fulvic Care Powder and Tablets were distributed by Black Oxygen Organics based in Ontario, Canada and sold online at www.blackoxygenorganics.com. The firm’s website is no longer in service. People who have Fulvic Care Powder and/or Tablets should immediately stop using the products and throw them away.
Exposure to Elevated Levels of Lead and Arsenic
Metals like lead and arsenic are found in the environment and enter our food supply through our air, water, and soil. The FDA monitors the levels of lead and arsenic in foods, dietary supplements, and cosmetics, because of their potential to cause serious health problems at elevated levels, and takes regulatory action when appropriate. Continued exposure to elevated levels of these metals can result in serious health risks and can affect people or animals of any age or health status. It can be especially harmful to vulnerable populations including infants, young children, pregnant women and their fetuses, others with chronic health conditions, and pets. Lead and arsenic poisoning can be diagnosed through clinical testing.
Summary of Problem and Scope
The FDA sampled Fulvic Care Powder at the Canadian border and found elevated levels of lead and arsenic. The FDA detained the shipment and put the product on Import Alert 99-42. Additional shipments of the Fulvic Care Powder were administratively detained after September 14, 2021, but the firm released those shipments into commerce without the FDA’s knowledge when they should have been held. When discovered, the FDA pursued a recall, however, the firm went out of business on November 23, 2021 before performing the product recall. The Canadian Food Inspection Agency (CFIA) conducted a recall of the Fulvic Care Powder and Tablets in September 2021, based on their own evidence and concerns with Black Oxygen Organics products. Because the Fulvic Care Powder and Tablets contain the same ingredients, the FDA is advising consumers to immediately discard both the Fulvic Care Powder and Tablets.
The FDA is issuing this Public Health Alert to advise consumers of the hazards of using Black Oxygen’s Fulvic Care Powder and Tablets or giving them to pets and recommends that consumers throw the products away. The FDA will continue to work with state and local partners to remove all contaminated products from the market.
Recommendations for Consumers
Consumers who have symptoms of lead or arsenic poisoning should contact their health care provider to report their symptoms and receive care.
To report a complaint or adverse event (illness or injury), you can
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Visit www.fda.gov/fcic for additional consumer and industry assistance.