|Company:||Prismic Light International, aka Sandent Co.|
|Issuer:||New Orleans District Office|
|Issued:||Aug. 14, 2008||Closed:||
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
August 14, 2008
WARNING LETTER NO. 2008-NOL-20
Delivery Signature Requested
Timothy M. Sanders, Owner
Prismic Light International, aka Sandent Co.
4711 Sulphur Springs Road
Murfreesboro, Tennessee 37129-7201
Dear Mr. Sanders:
On May 6-7, 2008, an investigator with the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 4711 Sulphur Springs Road, Murfreesboro, Tennessee. FDA has reviewed your product labels collected during the inspection and your websites at the Internet addresses www.prismiclight.com and www.sandentco.com. Based on this review, FDA has determined your CELL RENEW and CELL RENEW Essential Silica products are drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code 321(g)(1)(B)]. The therapeutic claims on your websites and on the product label for CELL RENEW Essential Silica establish your products are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. The marketing of these products with these claims violates the Act.
Specific examples of therapeutic claims observed on your websites and on your product label for CELL RENEW Essential Silica include:
CELL RENEW (Original Formula 1 fl. oz.)
• "CELL RENEW® provides optimal support for patients requiring chemotherapy and/or radiation. This extra support aids the body's ability to combat common chemotherapy side effects which include nausea, weight loss, and hair loss."
• ". . . relief from allergies . . . "
• "CELL RENEW® works for topical applications . . . . [S]upports the repair of tissue on contact at the cellular level. People using CELL RENEW® topically report optimal support when dealing with warts, . . . athlete's foot, fingernail and toenail fungus, diabetic ulcers and skin cancer."
CELL RENEW Essential Silica (Connective Tissue Support 4 fl. oz)
"CELL RENEW® Essential Silica has been formulated . . . to give maximum anti-inflammatory relief."
• "Reduction of pain & inflammation in the joints"
• "Anti-inflammatory and disinfectant"
• "Healing assistance and Pain Relief for burns"
• "Help with Alzheimer's by helping to remove aluminum"
Your websites also contain disease claims in the form of personal testimonials, including: "The biggest surprise was an immediate clearing of my sinuses. I have been struggling with allergies, which seem to keep me in a semi-stopped up state."
Your products are not generally recognized as safe and effective for the above referenced uses, and therefore, the products are "new drugs" under Section 201(p) of the Act [21 U.S.C. 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 U.S.C. 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective. Your products are also misbranded within the meaning of Section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] in which the labeling for these drugs fails to bear adequate directions for use.
In addition, based on the definition of the term "dietary supplement" under Section 201(ff)(2)(A) of the Act [21 U.S.C. 321(ff)(2)(A)], only products intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. Based on the claims for your CELL RENEW product observed on your websites, this product is intended for use in part as a topical treatment for various injuries (e.g., "CELL RENEW can be used, full strength or diluted, on cuts, scrapes or burns - including sunburned skin.") and for other non-ingested uses (e.g., "CELL RENEW may also be used in tepid bath or as a foot soak"). Therefore, CELL RENEW may not be marketed for these intended uses as a dietary supplement.
The violations cited in this letter are not intended to be an all-inclusive statement 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 or the occurrence of other violations. It is your responsibility to assure 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.
You are requested to 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.
During the inspection, our investigator observed unlabeled cardboard shipping cartons you identified as containing "CELLAID" for export to China. It is your responsibility under Section 801(e) of the Act [21 U.S.C. 381(e)] to ensure your product for export (1) accords to the specifications of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; (3) is labeled on the outside of the shipping package it is intended for export; and, (4) is not sold or offered for sale in domestic commerce.
Please send your reply to Karl 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.
H. Tyler Thornburg
New Orleans District
cc: John Sanford, Food Manufacturing Administrator
Tennessee Department of Agriculture
Ellington Agricultural Center - Porter Building
Box 40627, Melrose Station
Nashville, TN 37204