Website claims, cGMP violations, and label claims: FDA warning letter round-up


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Website claims, cGMP violations, and label claims: FDA warning letter round-up
A new raft of warning letters for dietary supplement companies from the US Food and Drug Administration (FDA) shows that current Good Manufacturing Practice (cGMP) and label claims continue to cause problems for companies.

‘A tutorial on disease claims’

In a warning letter dated August 1, 2013 to Sarasota, Florida-based Lumina Health Products, Inc. and it’s president, Mark Rubin, the FDA alleges that an inspection of the company’s facilities revealed “significant violations of FDA’s Current Good Manufacturing Practice (CGMP)”​, as well as labeling violations for the company’s Cellfood products, including Cellfood, Cellfood Natural Weight Loss Formula, Cellfood SAM-e Liquid Formula, and Cellfood Essential Silica Formula.

In a Legal Alert​ from the American Herbal Products Association, the warning letter is described as a “tutorial on how FDA ferrets out disease claims”.

“Regarding cGMPs, this letter demonstrates why companies relying on contract manufacturers to manufacture and label their products must confirm that they received what they order,”​ added the AHPA alert.

To read the full warning letter, please click here​.

Examining liquid products

A warning letter dated Jul 11, 2013 to Indio, CA-based Precise Nutrition International, Inc. and its president Carl B. Silkensen, is described as “a good example of how FDA examines what appears to be liquid products”​ by AHPA.

“This company manufacturers VitalErotic Shot and FDA's investigation details alleged cGMP violations that the company failed to adequately address in their response to the FDA Form 483,”​ said AHPA.

According to the warning letter, FDA alleges the company failed to perform any identity testing of ingredients and the 483 response did not provide documentation showing an implementation of corrective action. In addition, the FDA inspection found that finished batch verification to meet product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch was not being performed. The company’s response was said to be “inadequate” by FDA:

“Although you stated that you had ‘increased’ testing frequency, your written procedures indicated that you will continue to test every tenth batch of your finished products and you provided no statistical basis for this sampling plan. You are required to verify that either every finished dietary supplement batch or a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan meet the finished product specifications for identity, purity, strength, and composition [21 CFR 111.75(c)].”

Other issues raised by FDA included supplier qualification to establish the reliability of the supplier’s COAs, questions over the firm’s Master Manufacturing Records (MMR) and batch production records (BPR) for VitalErotic Shot.

To read the full warning letter, please click here​.

Website claims

A warning letter dated August 12, 2013 to Herbal Papaya, LLC, of Murphy, TX, focused on website claims.

According to FDA, the website (accessed July 2013) promotes the company’s products “Papaya Seed Extract”, “100% Papaya Leaf (Paw Paw Twig)”, “and “Papaya Leaf with Rooibos Tea” as drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

Claims for the various products included “aid with malaria and dengue fever”; “helps to reduce the risk of various types of cancers [and] fights viruses”; “helps to regulate blood sugar and therefore can play a role in reducing the risk of Type 2 diabetes … ”; and “may help to reduce the risk of Alzheimer’s disease.”

According to AHPA: “This warning letter provides examples of claims that should not be made on a website. The website makes claims regarding intestinal parasites, anti-bacterial properties of papaya seeds, and traditional use of papaya leaves to "aid with malaria and dengue fever." These are just a few of the unlawful claims that prompted FDA to warn Herbal Papaya.  FDA also highlights unlawful testimonials.”

To read the full letter, please click here​.

‘Unapproved New Drugs’

Finally, a May 24, 2013 letter to Sundial Herbal Products in Bronx, NY, alleged that the company offers products that FDA considers to be disease claims. The letter also cites cGMP violations identified during an inspection between October 4th though November 15th 2012, including not identifying incoming components and not having master manufacturing records and batch production records. Sundial is also warned about misbranding violations that include no supplement facts.

 “The letter serves as a check list of what not to do,” ​said AHPA.

To read the full letter, please click here​.

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