Supplement firm still in operation despite slew of disease claims, GMP violations

By Hank Schultz contact

- Last updated on GMT

Supplement firm still in operation despite slew of disease claims, GMP violations

Related tags: Gmp violations, Dietary supplement

A warning letter issued last month to dietary supplement firm Sound Healing Arts illustrates what’s wrong with the current enforcement picture at FDA, says an industry observer.

The University Place, WA-based company, which does business as Grounds for Tea, was cited for a plethora of disease claims it was making on its products, including cancer claims. In addition, the company was dinged by regulators for a slew of GMP violations of the most basic sort.

Sound Healing Arts is listed as an acupuncture clinic that has been packaging a line of dietary supplements under the Grounds for Tea brand name. FDA inspected the company’s manufacturing operations in December 2014 and reviewed the company’s website in October of this year. The facility inspection resulted in a number of 483 observations which the agency says were inadequately addressed and the website review revealed a wide variety of non-compliant disease claims.

Marc Ullman, Of Counsel with the firm Rivkin Radler LLC, said the wide scope of the violations in this case makes him wonder just what a company has to do to elicit a vigorous enforcement action from FDA. Something beyond a letter, in other words.

“Everyone that I have spoken to in the trade who actually cares about what they do is outraged,” ​Ullman said. “How is it that three weeks after they got the warning letter their website is still up making the same egregious claims?”

Disease claims

When accessed today the website, www.naturaldoctor.com​, still had a header titled “Many Cures for Many Illnesses”​ and “cure yourself the natural way with our herbal medicines” ​and advertises products suitable for consumers undergoing chemotherapy or radiation.

It’s not clear if some of the most egregious disease claims are still featured on the website.  The claims the company makes on its products causes them to be classified as unapproved drugs. Among the claims that the agency cited in the warning letter are: 

  • “This remedy treats a variety of malignancies…including:…Breast…Cervix…Colon…”
  • “RELAXES MUSCLE SPASMS AND CRAMPS IN ABDOMEN AND UTERUS…RELIEVES HEADACHES…PREVENTS BLOOD CLOTS…
  • “TINNITUS…BLURRED VISION…LOWERS HIGH BLOOD PRESSURE… HEART PALPITATIONS…AIDS CHRONIC KIDNEY FAILURE…CHRONIC HEPATITIS OR LIVER CIRRHOSIS…”

GMP violations

In the warning letter FDA said that it found a number of GMP violations in the company’s manufacturing facility in which it repackages for sale a number of materials it receives from contract manufacturers. The company lacked written standard operating procedures (SOPs), master manufacturing records (MMRs) and batch production records. The company also failed to establish procedures for the proper logging of incoming material and did not quarantine products for approval by appropriate quality control personnel before releasing products for distribtution. 

And in perhaps the most basic failure, the agency said an inspector discovered that production machinery had not been cleaned.

“Our investigator observed the packaging/counting machine, used to count and repack bulk encapsulated dietary supplement material into smaller finished product containers, contained various different colored capsules indicating that the machine had not been cleaned after previous runs,” ​the warning letter says.

The company’s response to this GMP violation, as to all the others, was deemed inadequate.  In all cases, the agency said the company gave no indication of what it would do to comply in the interim.

“Although you promised to immediately begin appropriate cleaning measures after each run and record this in the appropriate manner, you did not describe specific steps that will be taken to ensure the quality and proper packaging and labeling of the dietary supplement. No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim,”​ the agency wrote.

Slow response

Ullman said that he’s perplexed that a company can be this far out of compliance and can still be in operation, given the company’s apparent half-hearted response to the numerous 483 violations which it has had in its hands since February.

“This is a company that had no GMP program in place. Nothing. Their response to the 483 was, OK, we’ll start cleaning our equipment. We’ll let you know when we get around to doing that,”​ he said.

“I work with companies that have worked hard to comply with regulations and then there are companies like this that are allowed to operate and don’t seem to give a hoot. They were making serious disease claims and had zero quality control programs in place and it took FDA seven months to spit out a warning letter. Where’s the administrative detention?  Where’s the injunction?”​ Ullman said.

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