FDA Hands Life Support Development Warning Letter for Sale of Unapproved Drugs
The FDA has hit Life Support Development, a dietary supplement manufacturer and distributor, with a warning letter because its purported “hangover relief” product is considered an unapproved new drug.
The Columbus, Ohio-based company has claimed that its Life Support Hangover Relief aids “in the recovery from alcohol intoxication,” and “Life Support can protect the liver and brain from damage,” according to the Sept. 17 warning letter.
Even if the product wasn’t an unapproved new drug, it still would be an adulterated dietary supplement, the FDA says.
The company also failed to prepare and follow written master manufacturing records to ensure uniformity in finished batches and failed to follow written procedures for manufacturing operations and quality control, investigators noted during the Dec. 16, 17, 22 and 30, 2014, inspection.
Life Support’s batch production records also lacked complete information about the production and control of each batch, and the company failed to prepare a BPR every time a batch was produced. Complaint handling procedures were nonexistent, an employee told investigators, adding that there is no outline for investigating product complaints.
In addition, there were no procedures to ensure employees are qualified to conduct job functions. Employees also said that written procedures for packaging, holding and distributing were nonexistent. Further, the plant was not in a clean and sanitary condition, as product residue was on equipment, walls and the floor from a previous production run.
Failure to address and correct the violations may result in further FDA action, the letter says, including seizure of products and injunction.
Supplement makers are increasingly coming under fire for selling unapproved drugs and making unsubstantiated claims. Earlier this month, the Department of Justice, FDA and other federal partners announced a nationwide sweep that resulted in the filing of criminal and civil cases against 89 makers of dietary supplements.
In each of the cases, federal agencies alleged the supplements contained ingredients other than those listed on the label or made claims that were unsupported by adequate scientific evidence.
The FDA also has cracked down on online pharmacies for making false claims about products.
The company didn’t respond to a request for comment by press time.
To read the warning letter, go to www.fdanews.com/11-20-15-LifeSupport.pdf.