US FDA notes recall over ‘too much lead’, issues COVID-19 claim warning

The US Food and Drug Administration (FDA) has published an announcement of a product recall made voluntarily by a company after tests suggested the CBD oil contained too much lead.

Summitt Labs said a batch of its Kore Organic Watermelon CBD oil was found by the Florida Department of Agriculture and Consumer Services to contain lead levels at 4.7 parts per million (ppm).

The company tested another sample from the same batch and lot and found only 500 ppb (0.5ppm) – within the legal limit as defined by the state of Florida. However, in the interests of safety it nonetheless decided to proceed with the recall, the company said.

“Based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services,” Summitt added.

Meanwhile, another company has been castigated by the FDA for making claims that CBD – among other products – could cure or alleviate COVID-19.

The FDA warning to AgroTerra, which trades under the name Patriot Hemp Company, follows the same form as many of the other warning letters over claims related to COVID-19 and assorted other medical claims issued by the agency.

The letter highlighted claims the FDA believed to be unsubstantiated, such as: “The best natural defence and treatment of Coronavirus (and viruses in general) is a strong immune system…When your body is chronically stressed, your immune system suffers. With the spread of this potentially deadly Coronavirus, stress will be high…consider CBD Oil.”

AgroTerra was also criticised for making claims about a host of other products, ranging from colloidal silver to elderberry syrup. It was told to make immediate changes to rectify the claims.

The FDA said it would add the company to a list of firms in trouble for unsubstantiated COVID-19 claims, which would be updated when the company took actions to rectify its website and other promotional activities.


What This Means: The FDA says in its publication of the voluntary recall that the post does not act as an endorsement – it is only a public service. But one wonders whether it will lead to greater scrutiny.

After all, Summitt itself says the label of its Kore Organic states: “benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress,” which surely could be considered to be a medical claim.

So will the company end up facing another FDA letter for trying to do the right thing?

Freddie Dawson CBD-Intel staff

Print Friendly, PDF & Email