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Regulatory Focus™ > News Articles > 2019 > 10 > Warning Letters: FDA Cites Radiopharmaceuticals Firm, Chinese API Maker and CBD Seller

Warning Letters: FDA Cites Radiopharmaceuticals Firm, Chinese API Maker and CBD Seller

Posted 22 October 2019 | By Michael Mezher 

Warning Letters: FDA Cites Radiopharmaceuticals Firm, Chinese API Maker and CBD Seller

In warning letters released Tuesday, the US Food and Drug Administration (FDA) cites Virginia-based radiopharmaceuticals firm Sofie Co. for fungal contamination issues, Chinese drugmaker Jiangsu NHWA Pharmaceutical for product testing deficiencies and Florida-based Rooted Apothecary for making unsubstantiated health claims about its cannabidiol (CBD) products.
Sofie Co.
In its warning letter to Sofie, FDA calls out the company for repeated instances of fungal contamination in parts of its facility used to manufacture sterile positron emission tomography (PET) drugs.
Following a 10-day inspection of the company’s Dulles, VA facility in April, FDA says the company’s environmental monitoring program found several fungal species in ISO 5 areas from September 2018 to March 2019.
“The persistent, adverse trend of fungal contamination indicates that you did not have adequate control over these critical areas,” FDA writes, noting that the company continued manufacturing operations without adopting adequate measures to address the issue.
FDA also points out that fungal contamination is a repeat issue from a warning letter sent to another related company, N-Molecular Inc. (which does business as Sofie), last year.
“These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” FDA writes.
Jiangsu NHWA
FDA’s warning letter to Jiangsu comes after a five-day inspection of the company’s Jiawang facility last April that uncovered issues with the company’s product testing procedures and investigations into out-of-specification (OOS) test results for active pharmaceutical ingredients (APIs) distributed to the US.
According to FDA, Jiangsu NHWA followed stability testing protocols from the 2015 Chinese Pharmacopoeia for one of its APIs and was “not able to demonstrate that the tests used are equivalent to or better than the current [United States Pharmacopoeia] 42 compendial methods.”
FDA also says that the forced degradation studies used for another product were not validated.
Additionally, FDA says Jiangsu failed to adequately investigate OOS test results after two investigations failed to identify the source of foreign materials found in batches of one of the company’s APIs.
In response to the citations, Jiangsu said it will stop distributing products manufactured at the site until it has completed a corrective and preventative action (CAPA) plan, which FDA says it will need to verify before resuming distribution.
Rooted Apothecary
In a joint warning letter from FDA and the Federal Trade Commission (FTC), the two agencies cite Rooted Apothecary for making unsubstantiated claims that their CBD products can treat a range of health conditions from minor ailments such as teething pain to serious conditions including cancer and Alzheimer’s disease.
The warning letter comes as FDA considers how it will regulate CBD-based products and other products derived from cannabis after the Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill, legalized the cultivation and sale of hemp (cannabis containing less than 0.3% delta-9 tetrahydrocannabinol (THC)).
CBD-based products have proliferated amid the regulatory uncertainty, with major pharmacy chains and retailers including CVS, Walgreens, Rite Aid and Urban Outfitters announcing plans to carry CBD products in their stores.
“We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” said Acting FDA Commissioner Ned Sharpless, noting that the agency has sent dozens of warning letters to other companies making similar claims about CBD-based products over the last few years.
The warning letter itself cites Rooted Apothecary for claims made on its website and Facebook page that include various unsubstantiated claims such as “CBD may reduce the risk of cancer or help cancer treatment” and “CBD can have rapid and sustained antidepressant-like effects.”
The FTC also adds to the citations in the warning letter noting that it is unlawful “to advertise a product that can prevent, treat, or cure human disease unless you posses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”
As in previous warning letters to CBD-sellers, FDA has taken the stance that CBD is excluded from the definition of a dietary supplement as CBD is the active ingredient in an approved drug and “has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted.”
Sofie: Warning Letter
Jiangsu NHWA: Warning Letter
Rooted Apothecary: FDA, FTC, Warning Letter

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