Inspections, Compliance, Enforcement, and Criminal Investigations
F. H. G. Corporation 22-Aug-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
August 22, 2007
Lloyd E. Slabach, CEO/Co-Owner
Timothy J. Romero, President/Co-Owner
F. H. G. Corporation
dba Integrity Nutraceuticals International
201 Field End Street
Sarasota, Florida 34240
Dear Messrs. Slabach and Romero:
This letter is in reference to your firm's manufacture and distribution of your NutraVitals™ Cinnulin PF® product identified during our inspection conducted on March 23 through April 11, 2007, at your facility located at the above listed address. This inspection was conducted to determine your firm's compliance with the Federal Food, Drug and Cosmetic Act (the Act) and applicable implementing. regulations contained within Title 21 of the Code of Federal Regulations (21 CFR). In addition, the Food and Drug Administration (FDA) has reviewed labeling and/or promotional materials collected during the inspection and from your web sites at the Internet addresses http://www.integritynut.com, http://www.cinnulinpf.com and http://www.nutravitals.com and has determined that the product NutraVitalsTM Cinnulin PF® is promoted for conditions that cause this product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §321(g)(1)].
We acknowledge that you are attempting to implement corrections to your web sites by placing your web site for the product at the Internet address http://www.integritynut.com and http://www.cinnulinpf.com into the status of "Under Construction" and also removing therapeutic claims from your web site at the Internet address http://www.nutravitals.com following the inspection. However, the therapeutic claims you make for your product continue to establish that it is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act. You can find the Act and implementing regulations through links on FDA's Internet home page at http://www.fda.gov.
Examples of some of the disease claims observed in promotional materials for your, product include:
In your NutraVitals™ Cinnulin PF® ...an all-natural, patented water extract of cinnamon product. brochure, under the section "WHAT ARE THE ACTIVE COMPONENTS IN CINNULIN PF©?":
•"The active components in Cinnulin PF® are water-soluble Type-A Polymers. These polyphenol polymers or proantho-cyanidins are. . . known for their. . . anticancer. . . functions . . . ."
•"The polyphenolic polymers in cinnamon bark. . . may provide synergistic benefits to persons with various forms of diabetes."
Further, under the section "BENEFITS OF CINNULIN PF®"
• "Studies have shown that compounds in Cinnulin PF® not only stimulate insulin receptors, but also inhibit an enzyme that inactivates them, thus significantly increasing cells' ability to use glucose."
• "Cinnamon extract may also benefit pro-diabetics or individuals with impaired glucose tolerance that have not yet developed diabetes or other associated ailments. If you have any of these symptoms you could be at risk for prediabetes: * increased thirst * increased urination * increased appetite * fatigue * blurred vision * slow-healing infections * male impotence."
In your NutraVitais™ "Cinnulin PF- Blood Sugar got you, down" brochure, examples include:
• " . . .[C]innamon also has significant health benefits for Type II diabetics, including increased glucose metabolism and cholesterol management."
As a result of the foregoing disease claims, NutraVitals™ Cinnulin PF® is a misbranded drug under section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. Furthermore, insofar as the brochures quoted above accompany NutraVitals™ Cinnulin PF®, it is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use under the conditions suggested in the labeling. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violations are not meant to be an all-inclusive list of deficiencies in your products. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your web site, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative, products and/or injunction against the manufacturers and distributors of violative products:
We acknowledge receipt of a letter dated April 2, 2007 from your firm's legal counsel and also a letter dated April 19, 2007 from Mr. Romero. and Jean M. Trimbo, QC Coordinator, submitted to this office in response to our inspection. These letters do not alleviate our concerns with regard to the inspectional findings in that they do not provide sufficient information about corrective actions made with respect to the disease claims cited above.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over-time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Food and Drug Administration, Attention: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact Ms. Shambaugh at (407) 475-4730.
Emma R. Singleton
Director, Florida District