{"id":2146,"date":"2011-03-08T15:00:00","date_gmt":"2011-03-08T15:00:00","guid":{"rendered":"https:\/\/www.willclower.com\/blog\/2011\/03\/mama-mia-fda-busts-abba-pharmaceuticals-that-is.html"},"modified":"2016-09-21T09:12:49","modified_gmt":"2016-09-21T13:12:49","slug":"mama-mia-fda-busts-abba-pharmaceuticals-that-is","status":"publish","type":"post","link":"https:\/\/www.mymedwellness.com\/blog\/?p=2146","title":{"rendered":"Mama mia! FDA busts ABBA (Pharmaceuticals, that is)"},"content":{"rendered":"<div style=\"clear: left; float: left; margin-bottom: 1em; margin-right: 1em;\"><img data-opt-id=77099030  fetchpriority=\"high\" data-recalc-dims=\"1\" decoding=\"async\" src=\"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/merylstreep-tribute.com\/wp-content\/uploads\/2009\/05\/mamma_mia.jpg?w=735\" \/><\/div>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">The FDA has issued a warning letter to Florida-based dietary supplement manufacturer Abba Pharma because they are misrepresenting their products.<\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\"><br \/><\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\">Although these pill makers are urging you to <i>Take A Chance on Me<\/i>, they&#8217;re now in trouble because,&nbsp;<i>Mamma Mia!,<\/i>&nbsp;they&#8217;re pumping out pills like a <i>Super Trouper.&nbsp;<\/i><\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\"><i><br \/><\/i><\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\">But now they have to issue an&nbsp;<\/span><i>S.O.S. <\/i><span style=\"font-family: Arial, Helvetica, sans-serif;\">because of the multiple safety violations listed by the FDA. What happens next? Well, <i>Knowing Me, Knowing You<\/i>, there is nothing we can do because there is <i>Money, Money, Money <\/i>at stake here.&nbsp;<\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\"><br \/><\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\"><b>Bottom line?<\/b>&nbsp;<\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\">Kidding aside, Abba Pharma represents another reason why you should think very carefully about taking supplements at all because 1) the safety regulations are loose, and 2) their effectiveness is questionable anyway.&nbsp;<\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\"><br \/><\/span><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\">If you to take supplements, something you should do is to check out who is producing them. Safety actually is a concern and you should be aware of this.&nbsp;<\/span><br \/><i><br \/><\/i><br \/><span style=\"font-family: Arial, Helvetica, sans-serif;\">Here are the violations:&nbsp;<\/span><\/p>\n<div style=\"margin-bottom: 10px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><\/div>\n<ul style=\"margin-bottom: 10px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 15px; padding-right: 0px; padding-top: 0px; position: static;\">\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Failure to test every finished product batch or,&nbsp;<i style=\"outline-color: initial; outline-style: none; outline-width: initial; position: static;\">\u201ca subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan to determine whether the finished product meets established product specifications for identity, purity, strength, and composition of the dietary supplement\u201d<\/i><\/span><\/li>\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Failure to clarify Standard Operating Procedures for final product testing.<i style=\"outline-color: initial; outline-style: none; outline-width: initial; position: static;\">\u201cYour records indicate that you performed microbiological tests on the finished product, but this type of test does not verify the identity, purity, strength, and composition of the finished product.\u201d<\/i><\/span><\/li>\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Failure to establish component specifications for,&nbsp;<i style=\"outline-color: initial; outline-style: none; outline-width: initial; position: static;\">\u201cThiamine HCl, Riboflavin Phosphate, Pyridoxine HCl, Cyanocobalamin, Ascorbic Acid, Folic Acid, Niacinamide, D-Biotin, Calcium D-Pantothenate, Propylene Glycol USP, Glycerine 99.5%, Methylparaben, Propylparaben, Potassium Sorbate, Cremophor RH40, Triethanolamine, Aspartame, Orange Oil, and Purified Water\u201d.<\/i><\/span><\/li>\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Failure to identify ingredient identity testing protocols.&nbsp;<i style=\"outline-color: initial; outline-style: none; outline-width: initial; position: static;\">\u201cYour response does not specify, and you did not provide, supporting documentation on how you intend to ensure that you will verify the identity of each dietary ingredient used in the dietary supplements you manufacture.\u201d<\/i><\/span><\/li>\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Failure to establish and follow written procedures for,&nbsp;<i style=\"outline-color: initial; outline-style: none; outline-width: initial; position: static;\">\u201ccalibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement. Specifically, you did not have records of calibration for the scales used to weigh raw materials in the manufacturing of your dietary supplement products.\u201d<\/i><\/span><\/li>\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Failure to follow a written master manufacturing record (MMR) for each formulation and batch size<\/span><\/li>\n<li style=\"margin-bottom: 5px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><span style=\"font-family: Arial, Helvetica, sans-serif;\">Water use did not meet GMP requirements<\/span><\/li>\n<\/ul>\n<div style=\"margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"margin-bottom: 10px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial; background-position: initial initial; background-repeat: initial initial; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: scroll; background-clip: initial; background-color: transparent; background-image: url(http:\/\/www.nutraingredients-usa.com\/design\/news_site\/images\/sprites\/boxes_pix.gif); background-origin: initial; background-position: 50% 0%; background-repeat: repeat no-repeat; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: scroll; background-clip: initial; background-color: transparent; background-image: url(http:\/\/www.nutraingredients-usa.com\/design\/news_site\/images\/sprites\/boxes_pix.gif); background-origin: initial; background-position: 100% 50%; background-repeat: no-repeat repeat; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: scroll; background-clip: initial; background-color: transparent; background-image: url(http:\/\/www.nutraingredients-usa.com\/design\/news_site\/images\/sprites\/boxes_pix.gif); background-origin: initial; background-position: 50% 100%; background-repeat: repeat no-repeat; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: scroll; background-clip: initial; background-color: transparent; background-image: url(http:\/\/www.nutraingredients-usa.com\/design\/news_site\/images\/sprites\/boxes_pix.gif); background-origin: initial; background-position: 0% 50%; background-repeat: no-repeat repeat; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: scroll; background-clip: initial; background-color: transparent; background-image: url(http:\/\/www.nutraingredients-usa.com\/design\/news_site\/images\/sprites\/boxes.png); background-origin: initial; background-position: 0% -5px; background-repeat: no-repeat no-repeat; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\">\n<div style=\"background-attachment: scroll; background-clip: initial; background-color: transparent; background-image: url(http:\/\/www.nutraingredients-usa.com\/design\/news_site\/images\/sprites\/boxes.png); background-origin: initial; background-position: 100% -5px; background-repeat: no-repeat no-repeat; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: none; outline-width: initial; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; position: static;\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><span style=\"font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; font-weight: bold;\"><br \/><\/span><br \/><span style=\"font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; font-weight: bold;\"><br \/><\/span><br \/><a href=\"http:\/\/www.nutraingredients-usa.com\/Regulation\/Mama-mia!-FDA-busts-Abba-for-GMP-and-labeling-violations\/?c=d%2BEjT%2BDm97CSZvl03IBNog%3D%3D&amp;utm_source=newsletter_weekly&amp;utm_medium=email&amp;utm_campaign=Newsletter%2BWeekly\">Mama mia! FDA busts Abba for GMP and labeling violations<\/a><\/p>\n<p><a href=\"http:\/\/feeds.feedburner.com\/~r\/WillClowerRecipes\/~6\/6\" target=\"_blank\"><img data-opt-id=484575033  fetchpriority=\"high\" data-recalc-dims=\"1\" decoding=\"async\" alt=\"Will Clower Recipes\" src=\"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/feeds.feedburner.com\/WillClowerRecipes.6.gif?w=735\" style=\"border: 0;\" \/><\/a><a href=\"http:\/\/feeds.feedburner.com\/~r\/WillClowerOnTheCultureOfHealth\/~6\/5\" target=\"_blank\"><img data-opt-id=1945063305  data-opt-src=\"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/feeds.feedburner.com\/WillClowerOnTheCultureOfHealth.5.gif\"  class=\"optimole-lazy-only \"  data-recalc-dims=\"1\" decoding=\"async\" alt=\"Will Clower Health Articles\" src=\"data:image/svg+xml,%3Csvg%20viewBox%3D%220%200%20100%%20100%%22%20width%3D%22100%%22%20height%3D%22100%%22%20xmlns%3D%22http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%22%3E%3Crect%20width%3D%22100%%22%20height%3D%22100%%22%20fill%3D%22transparent%22%2F%3E%3C%2Fsvg%3E?w=735\" style=\"border: 0;\" \/><\/a><\/p>\n<div><a href=\"http:\/\/willclowerblog.blogspot.com\/\" layout=\"button_count\"><\/a><a href=\"http:\/\/willclowerblog.blogspot.com\/\"><\/a><a href=\"http:\/\/willclowerblog.blogspot.com\/\"><\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has issued a warning letter to Florida-based dietary supplement manufacturer Abba Pharma because they are misrepresenting their products.Although these pill makers are urging you to Take A Chance &hellip; <\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":true,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[494,256],"tags":[],"class_list":["post-2146","post","type-post","status-publish","format-standard","hentry","category-articles","category-supplements"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7Qv5g-yC","jetpack_likes_enabled":true,"jetpack-related-posts":[{"id":2206,"url":"https:\/\/www.mymedwellness.com\/blog\/?p=2206","url_meta":{"origin":2146,"position":0},"title":"FDA Deflates Male Enhancement Claims","author":"Will Clower","date":"December 16, 2010","format":false,"excerpt":"FDA warns consumers to avoid sexual enhancement pills(please share this with anyone who might consider this particular brand of crazy)The\u00a0Food and Drug Administration\u00a0is\u00a0warning men who\u00a0take\u00a0Man Up Now\u00a0capsules to stop\u00a0taking them immediately.\u00a0\u00a0The supplement contains a variation of\u00a0an active ingredient found in Viagra that can lower blood pressure to dangerous levels, the\u2026","rel":"","context":"In &quot;Articles&quot;","block_context":{"text":"Articles","link":"https:\/\/www.mymedwellness.com\/blog\/?cat=494"},"img":{"alt_text":"","src":"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/3.bp.blogspot.com\/_HAl9r2q_-j0\/TQlHweMJuII\/AAAAAAAAC1M\/r1r54NncLrQ\/s320\/FDA-Recall-Button.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":4472,"url":"https:\/\/www.mymedwellness.com\/blog\/?p=4472","url_meta":{"origin":2146,"position":1},"title":"Taking Supplements Is Like Charlie Brown Trying To Kick The Football &#8230; Again.","author":"Will Clower","date":"September 1, 2016","format":false,"excerpt":"FDA investigating high lead levels in supplements.\u00a0 Here's a quote; \"I'm so surprised that there are high lead levels in dietary\u00a0supplements taken for better health,\" said no one ever. How many reports have to come out about the irrelevance or outright harm that they can do? It doesn't really seem\u2026","rel":"","context":"In &quot;Articles&quot;","block_context":{"text":"Articles","link":"https:\/\/www.mymedwellness.com\/blog\/?cat=494"},"img":{"alt_text":"All bottles of Chicago-based Ton Shen Health's Life Rising DHZC-2 tablets were recalled last week after the FDA identified elevated levels of lead in product samples. (FDA)","src":"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/www.willclower.com\/blog\/wp-content\/uploads\/2016\/09\/ct-fda-herbal-supplement-recall-300x169.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2205,"url":"https:\/\/www.mymedwellness.com\/blog\/?p=2205","url_meta":{"origin":2146,"position":2},"title":"Good News! FDA: It&#8217;s now safe to dump your Sweet-n-Low down the drain","author":"Will Clower","date":"December 16, 2010","format":false,"excerpt":"Saccharine -- the synthetic sweetener of Sweet-n-Low -- has always been considered a potential carcinogen BUT, and I did not know this, also an environmental hazard!(please share this with any who still consume synthetic sweeteners of any stripe)\u00a0Just recently, however, the \"Calorie Control Council\" petitioned the Environmental Protection Agency to\u2026","rel":"","context":"In &quot;Articles&quot;","block_context":{"text":"Articles","link":"https:\/\/www.mymedwellness.com\/blog\/?cat=494"},"img":{"alt_text":"","src":"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/2.bp.blogspot.com\/_HAl9r2q_-j0\/TQoNbDvDrDI\/AAAAAAAAC1Y\/eeXd_bfdHR8\/s320\/Sweet-n-Low.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2675,"url":"https:\/\/www.mymedwellness.com\/blog\/?p=2675","url_meta":{"origin":2146,"position":3},"title":"Red Wine Pill: FDA takes a closer look","author":"Will Clower","date":"October 31, 2008","format":false,"excerpt":"Good for the FDA. 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Incredible.FDA weighs options to reduce painkiller overdoseshttp:\/\/m.apnews.com\/ap\/db_7731\/contentdetail.htm?contentguid=trS4c0e4Sent from my iPhone","rel":"","context":"In &quot;Articles&quot;","block_context":{"text":"Articles","link":"https:\/\/www.mymedwellness.com\/blog\/?cat=494"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":2393,"url":"https:\/\/www.mymedwellness.com\/blog\/?p=2393","url_meta":{"origin":2146,"position":5},"title":"FDA Yanks Kids&#8217; Meds","author":"Will Clower","date":"May 6, 2010","format":false,"excerpt":"The FDA did the right thing by pulling these meds, because they identified raw material containers tainted with bacteria that could make immune-compromised people even sicker.Turns out, though, that the bacteria were brought in from one of the suppliers, the contamination has still not be identified in ANY of the\u2026","rel":"","context":"In &quot;Articles&quot;","block_context":{"text":"Articles","link":"https:\/\/www.mymedwellness.com\/blog\/?cat=494"},"img":{"alt_text":"Bookmark and Share","src":"https:\/\/mlcmmqmgggev.i.optimole.com\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/i0.wp.com\/s7.addthis.com\/static\/btn\/v2\/lg-share-en.gif?resize=350%2C200","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/2146","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2146"}],"version-history":[{"count":1,"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/2146\/revisions"}],"predecessor-version":[{"id":3141,"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/2146\/revisions\/3141"}],"wp:attachment":[{"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.mymedwellness.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}