[131377]
Consumer has malignant melanoma which is under treatment and must rely on special tightly woven high spf protective clothing whenever he goes outside. Previously, he had been purchasing clothes from a firm called whetmore associates, who market spf 30 clothing under the brand name "solumbra". Investigator confirmed from the fda website that this firm got fda clearance to make the spf 30 claims on their clothing due to submissions to the agency. Consumer's concern is that the referenced catalog sales co makes spf 30 claims on page 420 of their latest catalog. He ordered a shirt and pants but there were no tags or other info on the spf 30 claim. When he called the distributor he got no answer and basically got the run around. They did say the products were assembled in china but refused to divulge the name of the mfr. He would like fda to be aware of this situation and to follow-up as this is a serious health hazard situation for people like him not to mention the long term affects on other people seeking to protect themselves from the sun, giving them a false security. He stated that the clothing weave does not appear to be tightly woven enough to make the spf 30 claim as does solumbra. Investigator told him that he would call the dist and attempt to get some info, but follow-up may have to made initially at another branch. On 5/25, investigator called dist, and spoke to a rep. The rep checked with the buyer: cabela did their own testing, and their results support a claim of spf 30 protection. Investigator asked if this was submitted to the fda. She did not believe it was and stated that they would not divulge "info". The investigator told her he would forward complaint.
Patient Sequence No: 1, Text Type: D, B5