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Good Herbs Warned for GMP, Claim Violations
July 5, 2012
3 Min Read
DETROITFDA warned Good Herbs Inc. CEO Brett C. Bashawaty that the company's facility operates in violation of cGMP (current good manufacturing practice) regulations and that company literature contains illegal marketing claims. The agency sent the company a warning letter on May 24, 2012.
cGMP Violations
FDA inspected the Good Herbs' facility, located in Troy, MI, for more than a monthfrom Nov. 16, 2011, to Jan 12, 2012and said it found significant cGMP violations, including:
Failure to establish quality control (QC) specifications.
Failure to provide documentation of identity specifications and failure to conduct identity testing of dietary ingredients
Failure to provide documentation for product specifications for the identity, purity, strength and composition of finished supplements. FDA noted that once the company has this documentation, it must also provide documentation that the specs have been met.
Several supplement master manufacturing records (MMRs) did not establish procedures to ensure each batch of dietary supplements meets the specifications.
The batch production records (BPRs) did not include required information, such as the identity of the equipment and processing lines used; the date and time of the maintenance, cleaning and sanitizing of equipment; the identity and weight of each component used; a statement of the actual yield and percentage of theoretical yield; documentation that the finished dietary supplement meets specifications; and documentation of dates and initials of employees that showed products met specs.
Failed to establish written procedures for packaging and labeling.
FDA said it received a response from the company on Jan. 25, but found it to be inadequate because the company did not provide documentation supporting its proposed corrective actions.
Marketing Claims
In addition, FDA reviewed the book titled, "A Practical Guide to Herbs" that the company distributes to its members. The company requires a membership to purchase products. FDA's review of this book found a several health claims for products that cause them be drugs because they were marketed as a cure, mitigation, treatment or prevention of disease.
FDA reported Good Herbs' AquaActive Tablets were promoted for treating high blood pressure and diabetes, its Capsicum was promoted for treating heart damage and heart attacks, and IMB-T and PO-K were promoted for treating bacterial and viral infections. The agency also noted other products such as HR-2, IMB-T PLUS and PARA-2-L also used drug claims in the book.
FDA noted the company seeks to avoid making drug claims by stating in its Member Wholesale Catalog (November 2011) These products are not intended for diagnosis, treatment, cure or prevention of any disease." However, FDA said such a disclaimer does not negate the drug claims the company makes.
INSIDER's Take
Good Herbs is one in a line of companies that are being cited by FDA for having both GMP and marketing violations (others include ABCO Labs, Caribe Natural LLC and Himalayan Institute of Buffalo). The point here is if FDA is going in for GMPs, it's also going to look at claims.
As far as GMPs, companies need to have documentation, MMRs and BPRs. Their QA employees need to be initialing these documents showing checks have been completed.
Companies also need to watch their claims no matter where they are made, be in online, in advertising or, as in this case, in a book supplied with products. Also of note here is that a disclaimer that a product isn't intended to treat diseases does not erase drug claims made elsewhere in the literature.
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