2 hours ago
While all drugs sold to American consumers face a rigorous approval process, that's not the case when it comes to supplements. The Food and Drug Administration (FDA) does not approve supplements, and while there are some limits to the claims that can be made by companies in this ******* e, there's a fair amount of latitude.
"The manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a 'disclaimer' that FDA has not evaluated the claim," according to the FDA website.
Supplement makers can make certain structure/function claims without FDA preapproval, as long as they have substantiation that the claims are truthful and not misleading, and that they meet the agency's other requirements.
"The disclaimer must also state that the dietary supplement product is not intended to 'diagnose, treat, cure or prevent any disease,' because only a drug can legally make such a claim," the federal agency shared.
It's a legal grey area that allows supplements to advertise that they can help with fitness, hair growth, sleep, and your ability to focus.
#claims #dietary
"The manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a 'disclaimer' that FDA has not evaluated the claim," according to the FDA website.
Supplement makers can make certain structure/function claims without FDA preapproval, as long as they have substantiation that the claims are truthful and not misleading, and that they meet the agency's other requirements.
"The disclaimer must also state that the dietary supplement product is not intended to 'diagnose, treat, cure or prevent any disease,' because only a drug can legally make such a claim," the federal agency shared.
It's a legal grey area that allows supplements to advertise that they can help with fitness, hair growth, sleep, and your ability to focus.
#claims #dietary
16 hours ago
While all drugs sold to American consumers face a rigorous approval process, that's not the case when it comes to supplements. The Food and Drug Administration (FDA) does not approve supplements, and while there are some limits to the claims that can be made by companies in this **** e, there's a fair amount of latitude.
"The manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a 'disclaimer' that FDA has not evaluated the claim," according to the FDA website.
Supplement makers can make certain structure/function claims without FDA preapproval, as long as they have substantiation that the claims are truthful and not misleading, and that they meet the agency's other requirements.
"The disclaimer must also state that the dietary supplement product is not intended to 'diagnose, treat, cure or prevent any disease,' because only a drug can legally make such a claim," the federal agency shared.
It's a legal grey area that allows supplements to advertise that they can help with fitness, hair growth, sleep, and your ability to focus.
#must #drug #substantiation
"The manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a 'disclaimer' that FDA has not evaluated the claim," according to the FDA website.
Supplement makers can make certain structure/function claims without FDA preapproval, as long as they have substantiation that the claims are truthful and not misleading, and that they meet the agency's other requirements.
"The disclaimer must also state that the dietary supplement product is not intended to 'diagnose, treat, cure or prevent any disease,' because only a drug can legally make such a claim," the federal agency shared.
It's a legal grey area that allows supplements to advertise that they can help with fitness, hair growth, sleep, and your ability to focus.
#must #drug #substantiation
