(a)
(1)
The sale or distribution of any dietary supplement product containing ephedrine group alkaloids is prohibited unless the product label clearly and conspicuously contains the following statement:
“THIS PRODUCT HAS (INSERT THE AMOUNT OF PRODUCT) MILLIGRAMS OF CONCENTRATED EPHEDRINE GROUP ALKALOIDS PER SERVING IN THE FORM OF HERBAL EXTRACTS.”
(2)
The sale or distribution
of any dietary supplement product containing ephedrine group alkaloids is prohibited unless the product label clearly and conspicuously contains the following warning:
(A)
“WARNING: NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 18 YEARS. DO NOT USE IF PREGNANT OR NURSING. Consult a physician or licensed qualified health care professional before using this product if you have, or have a family history of, heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, or if you are using a monoamine oxidase inhibitor (MAOI) or any other dietary supplement, prescription drug, or over-the-counter drug containing ephedrine, pseudoephedrine, or phenylpropanolamine (ingredients found in certain allergy, asthma, cough or cold, and weight control products).”
(B)
“Do
not exceed recommended serving. Exceeding recommended serving may cause serious adverse health effects, including heart attack and stroke.”
(C)
“Discontinue use and call a physician or licensed qualified health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms.”
(D)
“Individuals who are sensitive to the effects of caffeine should consult a licensed health care professional before consuming this product.”
(E)
“KEEP OUT OF REACH OF CHILDREN.”
(b)
The sale or distribution of dietary supplements containing steroid hormone precursors is prohibited unless the product label for these dietary supplements clearly and conspicuously contains the following warning:
“WARNING: NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 18 YEARS. DO NOT USE IF PREGNANT OR NURSING. Consult a physician or licensed qualified health care professional before using this product if you have, or have a family history of, prostate cancer, prostate enlargement, heart disease, low “good” cholesterol (HDL), or if you are using any other dietary supplement, prescription drug, or over-the-counter drug. Do not exceed recommended serving. Exceeding recommended serving may cause serious adverse health effects. Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen. Discontinue use and call a physician or licensed qualified health care professional immediately if you experience rapid heartbeat, dizziness, blurred vision, or other similar symptoms. KEEP OUT OF REACH OF CHILDREN.”
(c)
The product label for any dietary supplement product containing ephedrine group alkaloids or steroid hormone precursors shall clearly and conspicuously display the following statement: “To report any adverse events call 1-800-332-1088.”
