The order was announced yesterday by the US Food and Drug Administration. It was issued against Rahsan Hakim and Adoniiah Rahsan, principals of the firm Sundial Herbal Products, which is based in Bronx, New York. The company had a history of non compliance with FDA enforcement actions stretching back to at least 2012.
Long list of violations
The company’s regulatory history includes a laundry list of violations found on inspections from 2012 to 2017. Foremost among the violations are non compliant disease claims Sundial was making on its products.
- Clearing the intestines of parasites and cancer.
- Breaking up abnormal cysts and fibroids.
- Suppressing the growth of cancer
- Preventing heart disease, HIV/AIDS and other conditions.
In addition, the company had a history of noncompliance with GMP mandates. Those failures include a lack of specifications, deficiencies in master manufacturing records and batch product records, poor record keeping on equipment cleaning schedules and so forth.
The company was also cited for labeling violations, in that its products did not display a Supplement Facts panel as mandated by law.
After the 2017 inspection federal prosecutors filed a case in 2018 in the Southern District of New York against the pair, who reportedly described themselves as ‘bush doctors.’
“The defendants are the modern incarnation of snake oil salesmen, selling the unsuspecting public unapproved or misbranded drugs that they claim, without basis, will cure cancer, diabetes and other serious illnesses,” said prosecutors at the time.
The permanent injunction means Hakim and Rahsan would need to recall their products, hire competent quality personnel to ensure they make the needed changes to their processes and receive written permission from FDA before resuming operations. Industry observers say that while that pathway is offered as part of every injunction issued within the industry, few firms actually take the steps needed to resume operations.
Long time lines in regulatory enforcement
Larisa Pavlick, vice president of global regulatory and compliance for the United Natural Products Alliance, said while she’s not familiar with the specifics of the Sundial case, that long time lines in compliance actions can arise for a number of reasons. One issue that can gum up the works, she said, is if a reinspection to check on whether a company was implementing the promised changes was conducted by an inspector who was both unfamiliar with the particular case or even the product category, as with a seafood inspector looking at a dietary supplement operation. In those cases, things might get missed, and the company might get a clean bill of health, so to speak, and cycle back into an earlier stage of the regulatory process without really having achieved a sufficient level of compliance.