FDA warns North Idaho business of ‘serious violations’ with its sale of mineral supplements

A business in Kooskia that sells supplements, such as colloidal silver, violated federal law and regulations, according to a warning letter issued by the Food and Drug Administration.

The FDA inspected C R Supplements last year, between Dec. 6 and Dec. 10. That inspection and a review of the business’s website and Facebook page found “serious violations” of federal law and regulations, according to the letter, sent to owner Susan Hull on April 20.

C R Supplements sold several misbranded “new drugs,” according to the warning letter, which cited the products labeled Calcium, Copper, Molybdenum, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack. 

The company crossed a line into selling the substances as “new drugs” because they aren’t “generally recognized as safe and effective” for the uses marketed on the business’s Facebook page, the FDA said. 

The Idaho Capital Sun called and emailed Hull, who declined to comment.

Supplements are not regulated by the FDA — unless they are marketed and sold for uses that are FDA-regulated, such as to treat COVID-19 or cancer.

The FDA cited several claims made by C R Supplements in its marketing, such as, “Sorry, No Flu Shots Here! Try These Instead … Natural Flu Shots” with a photo of various supplements; and a claim that calcium would “keep your blood stream and other body liquids alkaline. … Harmful bacteria, virus and other disease causers do not thrive in an alkaline environment.”

During the pandemic, the health misinformation that already had roots in Idaho came to the forefront and began to have serious consequences. Idaho businesses and individuals began to target the sale of supplements like herbal products and silver, as false remedies and prophylactics for COVID-19. 

Silver has long been advertised as a natural remedy for many health issues like acne, herpes, weak immune system, low libido and hundreds more ailments, but the federal government’s National Center for Complementary and Integrative Health says colloidal silver may do more harm than good. 

Hull’s business last year had a bright yellow “Get your Colloidal Silver HERE” sign in the lawn out front.

The FDA said C R Supplements’ products were also misbranded because they “fail to bear adequate directions for its intended use,” meaning directions specific enough that nearly anyone could safely use the product as intended.

A Facebook post from June 18, 2020, markets C R Supplements’ products as the essential nutrients a healthy body needs in the form of ionic liquid mineral concentrates. Its post claims a lack of nutrients in the soil from modern industrial farming is causing a variety of health complications.

C R Supplements ships the mineral supplements internationally and sells wholesale, according to the website. 

The FDA’s inspection found that C R Supplements failed to specify every stage in the manufacturing process of the supplements to ensure quality, did not establish and follow written procedures for quality control operations, did not ensure packages were labeled to standard and failed to keep sufficient batch production records.

Even if the supplements did meet the legal criteria for drugs, they would be considered adulterated because of the business’s laboratory practices, the FDA said. And as supplements, the products were not properly labeled. For example, the silver and magnesium containers didn’t specify how much of the product children could take, the FDA said. 

The FDA letter said Hull responded to its findings in January but failed to show that she had fixed the violations. It gave her 15 business days to respond to the April warning letter. The FDA did not respond to a query from the Idaho Capital Sun. The letter warned Hull that if she does not address the violations, it could lead to legal action such as seizing or halting the business.

At the bottom of every product description on C R Supplements’ website as of June was a notice that states, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”