
المشاركة الأصلية كتبت بواسطة 071071
يعطيك العافية ياكابتن ولكن عندي سؤال :
الخبر هو كالتالي :
أصدرت إدارة الغذاء والدواء الأمريكية اليوم رسائل تحذير إلى عشرة المصنعين والموزعين للمكملات الغذائية التي تحتوي على :
dimethylamylamine والمعروف باسم DMAA
1,3H,-dimethylamylamine
methylhexanamine
geranium
وبعد مابحث باسم المنتجات المحضوره مثل :
Hemo Rage Black
Lipo-6 Black Ultra Concentrate
Lipo-6 Black
Lipo-6 Black Hers Ultra Concentrate
Lipo-6 Black Hers
Oxy Elite Pro
Jack3D
ما حصلت من ضمن مكوناتهم المواد اللي مذكورة بالتحذير !!! كيييييييييييييييف ؟؟ ممكن توضيح لاهنت
و عليكم السلام و رحمة الله و بركاته
اخي لو تابعت قرأة صفحة التحذير الخاصة بجمعية إدارة الاغذية و العقاقير لكنت وصلت الى التالي :
"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.
هذا التنبيه موجه للشركات المذكورة و هو يتهمها بالغش كونها لم تقدم دليلا على سلامة منتوجاتها نتيجة إحتواءها على المواد المحظورة و المشكوك بأمرها
دون ان تذكر ذلك على الــ سبلمنت فاكت ! او المكونات
و الرسالة التحذيرية تتابع بوجوب إجراء و تأكد من سلامة منتوجاتهم قبل طرحها في منافذ البيع بــ 75 يوما
كما ان الوكالة اي إدارة الاغذية و العقاقير ليس لديها علم بأن إستخدام هذه المكونات في المكملات الغذائية آمن
كما تواصل إدارة الاغذية و العقاقير التنبيه ان عدم وجود تحذير على المنتوج من إحتواءه على الــ FDA و الـ DMAA خاصة يتسبب بتضييق الاوعية الدموية و التسبب بإرتفاع ضغط الدم
كما إنها عنصر غير مصرح بإستخدامه في المواد الغذائية ( فئة المكملات تحت هذا البند )
و هي بالتالي غير مؤهلة لإستخدامها كعنصر في المكملات الغذائية
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"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.
Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.
The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.
The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.
The companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues in the warning letters.
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