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Tobacco Retailer Warning Letters. Recipient: Recipient Name. BMPEA is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, BMPEA is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake.
Finally, BMPEA is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Declaring BMPEA in your product labeling as a dietary ingredient causes your product marketed as a dietary supplement to be misbranded under section a 1 of the Act [21 U. We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your Phoenix Extreme product or other products marketed by your firm that contain BMPEA.
It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. Cannot wait to try it in a smoothie. Anonymous verified owner — January 11, I love taking this supplement, especially in the mornings as I usually workout super early!
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By Brand. Featured Items. Better Body Sports Nutrition Products. Articles Health Tip: Snack After Sports As you're packing your child's bag with sports gear, don't forget some healthy snacks. These foods play an essential role in keeping your child fit and fueled on the field. Tennis Anyone? It May Prolong Your Life If you want to try to extend your life, a new study suggests that taking up racquet sports might help.
Navigating Ski Slopes Safely Many people head for the slopes at the first sign of snow, but it's important to get into shape and take other safety precautions to ensure winter sports are fun and injury-free, the National Ski Areas Association NSAA cautions.
Boys More Likely to Hide a Concussion Than Girls When it comes to reporting a sports-related concussion, high school boys are less likely to speak up than high school girls, new research reveals. But there's a risk of infections if certain safety measures aren't followed, a new report from the American Academy of Pediatrics AAP warns.
We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your Phoenix Extreme product or other products marketed by your firm that contain BMPEA. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
Failure to immediately cease distribution of your Phoenix Extreme product, and any other products you market that contain BMPEA, could result in enforcement action by FDA without further notice. Sections and of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U. Additionally, BMPEA is not approved as a food additive or prior sanctioned for use in dietary supplements.
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response.
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