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Regulatory Focus™ > News Articles > 2019 > 7 > FDA Warns CBD Seller, HCT/P Maker and Indian Drugmaker

FDA Warns CBD Seller, HCT/P Maker and Indian Drugmaker

Posted 23 July 2019 | By Michael Mezher 

FDA Warns CBD Seller, HCT/P Maker and Indian Drugmaker

In the latest batch of warning letters from the US Food and Drug Administration (FDA), the agency warns a major cannabis seller for making unsubstantiated therapeutic claims about its cannabidiol (CBD) based products, a US-based biotech company over human cell, tissues, and cellular and tissue-based products (HCT/P) violations and an Indian drugmaker for good manufacturing practice (GMP) violations.
Curaleaf Holdings
In its warning letter to Curaleaf Holdings, FDA says the company marketed products containing CBD on its website and social media with unsubstantiated claims that the products could treat a range of diseases including cancer, Alzheimer’s disease, chronic pain and anxiety.
Curaleaf became the world’s largest legal cannabis seller after buying rival firm Grassroots Cannabis in an $875 million deal announced last week.
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 in recent years, with major pharmacy chains and retailers including CVS, Walgreens, Rite Aid and Urban Outfitters announcing plans to carry CBD products in their stores.
In addition to citing the firm for marketing its CBD products as unapproved new human and animal drugs, FDA takes issue with the company’s claim that the products are dietary supplements.
According to FDA, CBD is excluded from the definition of a dietary supplement as it “has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.” FDA also notes that three of the products are intended to be administered topically, via a transdermal patch or via inhalation, which would further preclude those products from being considered dietary supplements as the Federal Food, Drug, and Cosmetic Act only allows for dietary supplements that are intended to be ingested.
Last year, FDA approved GW Pharmaceuticals’ CBD-based drug Epidiolex (cannabidiol) to treat two rare forms of epilepsy.
In response, Curaleaf said Tuesday it plans to address the issues raised in the warning letter and defended the quality of its products. “We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the company’s cultivation and manufacturing processes,” noting that all of its CBD products are derived from hemp and “meet the requirements” of the Farm Bill.
Stratus BioSystems
FDA’s warning letter to Stratus BioSystems cites the company for HCT/P violations related to its Amniotic Membrane Patch Allograft product. The warning letter also specifies that the agency has not evaluated the compliance status of two of Stratus’s other products.
According to FDA, the firm manufactured the allograft patch without adequately validating its manufacturing processes to ensure that any contamination is removed, and that processing prevents the introduction, transmission or spread of communicable diseases. FDA says the company has distributed its Amniotic Membrane Patch Allografts without a validated process since March 2018.
FDA says the company failed to clean, sanitize and maintain a piece of equipment used to sterilize processing equipment and supplies used to manufacture its Amniotic Membrane Patch Allograft products, noting that the company had not performed certain maintenance on the equipment “since [it] began operations in March 2018.”
FDA also says Stratus failed to discard donor materials that tested positive for Staphylococcus aureus and Clostridium perfringens. FDA notes that the company’s procedures call for discarding samples that test positive for either organism.
Additionally, FDA cites the company for failing to document donor eligibility for donors of amniotic membrane, failing to retain records for some of its HCT/Ps and failing “to establish and maintain procedures appropriate to meet core current good tissue practice (cGTP) requirements for all steps that [it] perform[s] in the manufacture of HCT/Ps.
FDA acknowledges that the company has since ceased processing HCT/Ps as it works to implement new procedures and conduct staff re-training.
Indoco Remedies Limited
In a letter dated 9 July, FDA warned Mumbai, India-based Indoco Remedies Limited over GMP and data integrity violations at its Goa facility following a nine-day inspection earlier this year.
According to the warning letter, the company failed to generate batch production and control records with all necessary values for products intended for the US market.
Specifically, FDA says that values for the company’s compression machine process controls were written by hand in records used to release product, while values recorded by the machine’s programmable logic controller were “frequently outside [the firm’s] established process parameters.” FDA notes that this is a repeat issue from a 2018 inspection.
FDA also says that Indoco failed to thoroughly investigate unexplained discrepancies in batches of its products and on several occasions was found to have repeated analyses following an out-of-specification (OOS) test result until a passing result was obtained.
“These analyses included water content tests on a Karl Fischer instrument and an assay test on an auto titrator instrument. We reviewed the electronic data on these instruments and found OOS testing results which were not reported in the analytical records. Only passing results were ultimately included in the data presented for batch review and disposition decisions,” FDA writes.
Curaleaf Statement, Warning Letter
Stratus BioSystems Warning Letter
Indoco Warning Letter

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