Inspections, Compliance, Enforcement, and Criminal Investigations
Nutritional Counselors of America 09-Jun-08
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
June 9, 2008
WARNING LETTER NO. 2008-NOL-15
DELIVERY SIGNATURE REQUESTED
June M. Wiles, Owner
Nutritional Counselors of America
1267 Archie Rhinehart Parkway
Spencer, Tennessee 38585
Dear Ms. Wiles:
On December 3-4, 7, 2007 and January 3, 2008, an investigator with the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1267 Archie Rhinehart Parkway, Spencer, Tennessee. During this inspection, our investigator collected samples of your product labels. Our review of your labels found some of the products you manufacture are drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)(B)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. Examples of some of the claims on your product labels which demonstrate the products' intended use as drugs include:
• "[A]ids in healing of burns and wounds."
• "[H]elps prevent epilepsy, and has been used for bipolar disorder."
• "May be beneficial for relief of cooling fever . . . depression, virus attacks . . . ."
• "Hawthrone [sic] may help normalize blood pressure . . . ."
• "[S]uperior for killing flukes."
Olive Leaf Extract
• "[M]ay be beneficial against viruses, bacteria, strep and staph and is a strong antimicrobial."
Beta 1-3, 6D Glucan
• "[H]as shown positive effectiveness for surface healing . .. and sun bum."
Since these products are not generally recognized as safe and effective when used as labeled, they are "new drugs" under Section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 USC 355(a)]. Your "L-Glycine," "Graviola," "Hawthorne Berry," "Cloves," "Vanadyl Sulfate," "Olive Leaf Extract," and "Pine Bark Extract" products are also misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)], because their labeling does not bear adequate directions for use.
Further, your "Maturity" product is misbranded under Section 403(a)(1) of the Act [21 USC 343(a)(1)], because its labeling is false and misleading. Specifically, several of the nutrient daily value percentages are incorrect. For example, the amount of thiamin on the label, 50 mg, is declared as 33% of the Daily Value, which is calculated as a percent of the Reference Daily Intake (RDI). However, because the RDI for thiamin is 1.5 mg [21 CFR 101.9(c)(8)(iv)], 50 mg of thiamin is 3333% of the Daily Value.
Your "Maturity" and "Multivite" products are also misbranded within the meaning of Sections 403(a)(1) and 201(n) of the Act, because they contain iron for use as an iron source but fail to bear the warning statement required. under 21 CFR 101.17(e).
The issues and violations cited in this letter are not intended to be an all-inclusive list of violations which exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of Federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other Federal agencies may take this warning letter into account when considering the award of contracts.
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 timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
A description of the new drug approval process can be found on FDA's Internet website at www.fda.gov/cder/regulatory/applications/default.htm.
Please send your reply to Kari L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.
Patricia K. Schafer
Acting District Director
New Orleans District
Enclosure: Form FDA 483