Recalls & Warnings
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Posted October 18, 2016
Seller of Sublingual Vitamins Warned for Drug Claims
On August 31, 2016, the FDA issued a warning letter to Bio-Stasis International, Inc., following a review of the company's website which found statements made about its sublingual tablets, ViraPress, Vitamin D-3 and Vitamin B-12. to be drug claims.
For example, ViraPress was promoted with statements such as "a new and effective sublingual tablet which enhances the immune system and may increase protection while reducing fever symptoms from various viral infections." Vitamin B-12 was promoted with statements such as "enhances production of antibodies, so critical in any infection," and Vitamin D-3 was promoted with statements such as "Researchers have found that vitamin D ... signals an antimicrobial response to some infections."
In addition, the FDA noted that these products are not dietary supplements because they are taken sublingually - made to dissolve under the tongue rather than swallowed. Dietary supplements must be intended for ingestion.
See Are lozenges and sublingual pills considered dietary supplements? for more about this.
See Related Warnings:
To read the FDA's warning letter, use the link below.