Department of Health and Human Services
Public Health Service
Baltimore District Office
April 21, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Robert Crim, CEO
SHS North America
9900 Belward Campus Dr #100
Rockville, MD 20850-3970
Dear Mr Crim:
The Food and Drug Administration (FDA) collected samples of XPhe Maxamum, a medical food product distributed by your firm and marnufactured by SHS International. Our analysis shows the product to be misbranded under the provisions of the Federal Food, Drug and Cosmetic Act (the Act). You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.
Our analysis of the product found the following:
SHS-XPhe Maxamum, lot # 4042?9A. MFD 11/2004, EXP 11/2007
Vitamin D: analysis found 231% of declared (original) and 31% (check analysis)
These findings cause your XPhe Maxamum product to be misbranded under section 403(a)(1) of the Act [21 USC 343(a)(1)] because the product label is false or misleading, in that it does not correctly represent the amount of nutrients present in the product.
The above violation is not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufactuers distributors of those products. You should take prompt action to correct these deviations and prevent their uture recurrernce. Failure to do so may result in enforcement action without further notice.
Because medical foods are sued for the dietary management of diseases and conditions with distinctive nutritional requirements, over- and under-declaration of nutrients in medical foods are of particular concern to FDA. We earlier collected and analyzed samples of the product Pediatric E28, a medical food distributed by your firm and manufactured by [redacted]. Our analysis found that the amount of Vitamin A (as retinyl palmitate) in the product was more than 200% of the amount declared on the label, and the amount of Vitamin C in the product was more than 1000% of the amount declared on the label. Excessive intake of certain nutrients can result in toxicity and serious adverse health consequences; for example, excessive intake of Vitamin A can cause anorexia, swelling of bones, and limitation of motion, among other symptoms. We strongly recommend that you review the nutrient content of all of your products as soon as possible.
Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violation noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Please send your reply to Kirk D. Sooter, Compliance Branch Director, at the address above. If you have questions regarding any issues in this letter, please contact Mr Sooter at 410-779-5412.
This page was revised on February 18, 2008.