Proper Nutrition Inc.
FDA issued a warning letter to Proper Nutrition Inc. (West Chester, PA) regarding four dietary supplement products — Colostrum 70/40, Intestive, Seacure, and SeaVive — whose website marketing claims established drug intent under the FD&C Act. The claims included treating wound healing, Crohn's disease, IBS, colitis, AIDS, chemotherapy side effects, and killing viruses and bacteria, rendering the products unapproved new drugs. FDA also found Seacure and SeaVive misbranded for lacking adequate directions for use, and warned that failure to correct violations may result in seizure or injunction.
Flagged claims (13)
Boswellia [an ingredient in Intestive] is a plant used for centuries … as an anti-inflammatory and anti-irritant.
. . . beneficial in treating digestive problems and wound healing and for conditions that cause a general malaise, such as AIDS, or treatments like chemotherapy.
. . . natural contents provide essential immunoglobulin and other powerful immune factors to kill, block and inhibit the daily threat from viruses and harmful bacteria, particularly in the digestive tract and lungs.
. . . proven to be very beneficial in wound healing . . ..
. . . health care practitioners report how pleased they are with Seacure®. Through their own clinical experience, they know that the bioactive peptides work directly in the gastrointestinal tract to reduce symptoms and restore gut integrity in patients with Crohn's, IBS, malabsorption and other gut related problems.
. . . trigger a sequence of events that . . . reduce inflammation.
. . . proven beneficial to wound healing
. . . supplies immune factors to the intestinal lining to ward off infection . . .
Colostrum 70/40® contains valuable immune factors that form antibodies to protect against infection. It also provides grown and immune factors, which are essential for … repairing wounds and tissue injuries.
SeaVive helps correct pathogenic bowel permeability and prevents hazards from passing through the gut membrane to infect internal organs.
The bioactive peptides found in products such as Seacure® and Seavive® work directly in your gastrointestinal tract to reduce the symptoms of digestive disorders …. These peptides have also shown to be beneficial in wound healing
Proper Nutrition's dietary supplements bring relief to patients suffering from a range of digestive disorders, including: o Irritable Bowel Syndrome – Also known as IBS, this intestinal disorder occurs in the colon and small intestine . . . o Colitis – A chronic illness in which the lining of the colon becomes inflamed and develops ulcers. o Leaky Gut Syndrome – This condition is . . . often associated with diseases such as Crohn's or Celiac.
. . . Colostrum 70/40® is a bovine colostrum that provides Growth Factors and Immune Factors, which are essential for . . . wound or tissue repair.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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