Chart: Dietary Supplement Claims Subject To FDA "Courtesy" Letters
This article was originally published in The Tan Sheet
Executive Summary
Dietary Supplement Claims Subject To FDA "Courtesy" Letters
<table border="1" cellspacing="1" bordercolor="#c0c0c0" cellpadding="7" width="672"> <tr> <td valign="top"> <br /> <br /> <p> <b><font face="Times" size="5">Dietary Supplement Claims Subject To FDA "Courtesy" Letters</font></b> </p> </td> </tr> <tr> <td valign="top"> <p> <b><i><font face="Times" size="1">"Courtesy" letters, or "letters of objection," are sent by FDA to notify dietary supplement companies of claim provision violations under the Dietary Supplement Health & Education Act; F-D-C Reports, Inc. compiled the redacted list from information recently made available by the agency.</font></i></b> </p> </td> </tr> </table> <table border="1" cellspacing="1" bordercolor="#808080" cellpadding="7" width="670"> <tr> <td width="32%" valign="top" bgcolor="#ffffff"> <p> <b><font face="Helvetica Condensed" size="1">Company</font></b> </p> </td> <td width="53%" valign="top" bgcolor="#ffffff"> <p> <b><font face="Helvetica Condensed" size="1">Product/Ingredient</font></b> </p> </td> <td width="15%" valign="top" bgcolor="#ffffff"> <p> <b><font face="Helvetica Condensed" size="1">Date</font></b> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">A&A Customs Brokerage Services</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Long Life Colostrum Gold Plus</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/12/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Increased 100% effectiveness. Helps support immune function while helping to fortify the health and maintenance of the gastrointestinal system"; "Supports immune function. Helps to increase vitality and stamina. Powerfully naturally anti-aging."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Beutlich Pharmaceuticals</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Periden-C</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/12/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Assists in wound healing."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Biotech Corp.</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Prostate Gold</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">5/1/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Lessen nocturnal urination and help to restore normal function."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Enzymatic Therapy</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">MygraClear with patented Petadolex (purple butterbur)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Dietary supplement for proper blood vessel structure and blood flow in the brain"; "Doctor recommended MygraClear with Petadolex features a patented extract of butterbur to support healthy blood vessel tone in the brain, as well as healthy blood flow in the brain."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Enzymatic Therapy</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">MygraClear with patented Petadolex (purple butterbur)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Dietary supplement for healthy blood vessel tone in the brain"; "Dietary supplement for healthy blood vessel tone and blood flow in the brain; "Studies demonstrate MygraClear with Petadolex is safe and well tolerated"; "It has been the subject of two placebo-controlled clinical studies. In the most recent, participants reported a 71% improvement"; "71% improvement reported"; "It has been the subject of two placebo-controlled clinical studies. In the most recent, participants reported a 62% improvement."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Enzymatic Therapy/PhytoPharmica</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">MygraHealth with Patented Petadolex (purple butterbur root extract)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"62% improvement reported."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Enzymatic Therapy/PhytoPharmica</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">MygraPreve with Patented Petadolex (purple butterbur root extract)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Dietary supplement for healthy blood vessel tone in the brain"; "Dietary supplement for healthy blood vessel tone and blood flow in the brain"; "Studies demonstrate MygraPreve with Petadolex is safe and well tolderated"; "Dietary supplement for proper blood vessel structure and blood flow in the brain"; "Doctor recommended MygraPreve with Petadolex features a patented extract of butterbur to support healthy blood vessel tone in the brain, as well as healthy blood flow in the brain."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Enzymatic Therapy</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Petadolex Patented Brain Support (purple butterbur root extract)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">5/6/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">""Neurologist recommended Petadolex contained patented extract of butterbur that supports healthy blood vessel tone and normal blood flow in the brain"; "Patented brain support"; "Healthy brain function is characterized by lack of headache, lack of auras, lack of nausea or vomiting, and lack of sensitivity to light and sound; promotes leg vein health"; "Normal blood vessel tone in the brain is characterized by lack of headache, lack of auras, lack of nausea or vomiting, and lack of sensitivity to light and sound"; "In a recent placebo-controlled clinical study participants reported a 62% improvement."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Enzymatic Therapy/PhytoPharmica</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">FlexAgility (ginger, greater galangal)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">1/2/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Reduces joint pain and stiffness due to everyday activity"; "Reduces joint pain and stiffness due to occasional overuse"; "This unique combination gives FlexAgility the triple-action power to reduce joint pain and stiffness due to occasional overuse, and protect the integrity of cartilage"; "Clinical studies have shown significant effects after two weeks of using this formula, and even more significant results after six weeks of use."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Health From the Sun</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Basikol Capsules</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">1/4/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Helps maintain healthy cholesterol levels"; "Maintain a healthy heart system"; "Beneficial effects to maintain a healthy heart and normal cardiovascular system"; "Supplying 800 mg phytosterols, shown to maintain healthy cholesterol levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Herb Pharm</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Artichoke Liquid Herb Extract</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/19/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Helps maintain a healthy cholesterol level."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Lifeline Technologies</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">ChoLESStolife</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">5/3/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Lowers cholesterol absorption in the small intestine to help retain healthy cholesterol levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">NBTY</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Glucosamine/MSM</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Perfect for individuals experiencing minor joint aches."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Natural Factors Nutritional Products</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">B6 500 (Pyridoxyne); B6 100 mg (pyridoxine HCl)</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Deficiency of vitamin B6 is characterized by depression, glucose intolerance, anemia, impaired nerve function, cracking of the lips and tongue and seborrhea or eczema."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Natural Factors Nutritional Products</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Betaine Hydrochloride</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Help[s] maintain healthy blood sugar levels"; "Maintains blood sugars levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Natural Factors Nutritional Products</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Chromium & Vanadium</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Helps control the blood sugar level and help maintain healthy cholesterol levels"; "Helps maintain healthy blood sugar levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Natural Factors Nutritional Products</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Chromium GTF</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Helps the body maintain a normal blood sugar level"; "Helps maintain a healthy cholesterol level"; "Maintains healthy blood sugar levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Natural Factors Nutritional Products</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Magnesium Oxide; Magnesium Chelate</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/21/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Signs of magnesium deficiency include fatigue, mental confusion, irritability, heart disturbances, muscle cramps, insomnia and a predisposition to stress"; "For optimal magnesium levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Novartis</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Maalox DS Softchews</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">1/14/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Builds and maintains strong healthy bones"; "Relief of occasional heartburn"; "May reduce the risk of osteoporosis."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">NOW Foods</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Total Maintenance</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/13/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Supports healthy blood glucose levels."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Pharmavite Corp.</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Folic Acid</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">4/17/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"A deficiency of folic acid during pregnancy has been linked to several birth defects, such as the neural tube defect spina bifida. Therefore, it is critical for women of child-bearing age to consume 400 mcg of folic acid per day."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Solgar Vitamin & Herb</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Gold Specifics Cholesterol Support</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">1/28/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Cholesterol support"; "Circulatory."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Solstice Medicine Company</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Ryukakusan Herbal Candy</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">1/9/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Supports the health of the respiratory system and refreshes at the same time."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Source Naturals</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Beta Sitosterol Complex</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/13/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Maintain normal cholesterol levels when consumed as part of a low cholesterol dietary program."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Source Naturals</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Calcium Citrate</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/13/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Helps support and maintain a healthy skeletal system, especially during the menopausal years when bone loss increases."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Standard Process</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">For-Til B12</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">2/4/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Support normal glucose and cholesterol at normal levels with a well balanced diet."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Tom's of Maine</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Natural Bronchial Syrup for Children; Natural Bronchial Syrup for Adults</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/13/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Sooth[es] dry throat."</font> </p> </td> </tr> <tr> <td width="32%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Tsunami Supplements</font> </p> </td> <td width="53%" valign="top"> <p> <font face="Helvetica Condensed" size="2">Wakame Heart Health Formula</font> </p> </td> <td width="15%" valign="top"> <p> <font face="Helvetica Condensed" size="2">3/12/02</font> </p> </td> </tr> <tr> <td valign="top" colspan="3"> <p> <font face="Helvetica Condensed" size="2">"Neutralizing 'bad' cholesterol (LDL) by minimizing oxidation. Oxidized LDL is known to cause plaque build-up in the blood vessels."</font> </p> </td> </tr> </table> |