|
Public Health Service Food and Drug Administration |
| Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
Department of Health and Human Services
July 15, 2013
Ref: 2013-DAL-WL-041
WARNING LETTER
UPS OVERNIGHT MAIL
Evan Reynolds, President
The Magni Group, Inc.
dba Magnilife
7106 Wellington Point Road
McKinney, TX 75070-5705
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the information on your website http://magnilife.com for your marketed products which include, but are not limited to, "Diabetic Neuropathy Foot Cream," "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Fat Dissolver Cream," "Fibromyalgia Relief Tablets," "Lung Cream," "Sciatica Relief Tablets," "Sciatica Pain Relief Cream," "Shingles Recovery Cream," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets." As described below, the marketing of these products violates the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Homeopathic Drugs
FDA reviewed the labeling claims on your website http://magnilife.com for your products "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets;" and determined they are misbranded under sections 503(b) and 301(a) of the FD&C Act [21 U.S.C. §§ 353(b) and 331(a)]. Labeling claims observed for "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets" on your website include, but may not be limited to, the following:
Diabetic Neuropathy Foot Cream
• "Diabetic Neuropathy Foot Cream"
• "Neuropathy pain in feet? Calms …sensations caused by diabetic nerve pain ..."
• "Gelsemium sempervirens 6X HPUS …Acts upon nerves"
• "I have had neuropathy for 5 years. The tingling and burning in my feet and legs has been terrible …I tried your Magnilife Diabetic Neuropathy Cream …within 5 minutes the pain eased."
• "It helps ongoing neuropathy, both from Type II diabetes and from cancer treatment ..."
• "My wife is a diabetic and has severe neuropathy in her feet…[t]his foot cream …immediately took the pain away."
Fibromyalgia Relief Tablets
• "Fibromyalgia Relief Tablets"
• "Fibromyalgia Relief Tablets help relieve the chronic, widespread pain in the shoulders, back, neck, arms, and legs usually accompanied with extreme fatigue."
• "Aconitum napellus 30C HPUS ...Relieves inflammation and pain in joints and tendons"
• "Belladonna 30C HPUS …Acts upon nerve centers that produce pain"
• "Coniinum 30C HPUS ...Affects nerves and muscles"
• "Gelsemium sempervirens 30C HPUS …Relieves muscular weakness, twitching, and paralysis"
• "Hypericum perforatum 30C HPUS ...Reduces pain and nerve sensitivity"
• "Kali bichromium 30C HPUS ...Relieves pain, stiffness, and swelling in joints"
• "Lacticum acidum 30C HPUS . . .Relieves rheumatic pains"
Sciatica Relief Tablets
• "Sciatica Relief Tablets"
• "Sciatica Relief Tablets help relieve the intense, radiating pain in the buttocks and lower back .. ."
• "Colocynthis 6X HPUS …Relieves sciatic pain"
• "Magnesia phosphorica 6X HPUS …Relieves radiating pains and numbness; sciatica"
• "I suffered with a terrible pain in my lower back … I assumed it was part of my spinal stenos us [sic] until I read an ad ...for your sciatica relief formula ….I bought a bottle and started taking it as directed. In two to three weeks my pain was gone."
• "I suffered with sciatica for 5 years …I saw your Sciatica Relief tablets … tried them and within a week, NO MORE PAIN!"
• "I would definitely recommend these tablets to anyone looking to relieve the pain … Sciatic nerve can cause."
Tinnitus Relief Tablets
• ”Tinnitus Relief Tablets"
• "Tinnitus Relief Tablets help relieve symptoms of tinnitus …"
• "Chininum sulphuricum 6X HPUS …Relieves violent ringing, buzzing, and roaring in ears"
• "Kali carbonicum 6X HPUS… Reduces noises in the ears"
• "Lycopodium clavatum 6X HPUS .. .Relieves humming and roaring with hardness of hearing; echoing"
Urinary Incontinence Relief Tablets
• "Urinary Incontinence Relief Tablets"
• "Overactive bladder? Urinary Incontinence Relief helps relieve the sudden urge to urinate, followed by the involuntary loss of urine (overactive bladder), as well as the inability to empty bladder ..."
• "Urinary Incontinence Relief Tablets contain seven different active ingredients that address multiple types of incontinence."
• "Causticum 6X HPUS ..Relieves nighttime incontinence"
• "Natrum muriaticum 6X HPUS …Relieves involuntary urination"
• "Nux vomica 6X HPUS … Relieves overactive bladder and dribbling"
• "Pulsatilla nigricans 6X HPUS . . . Relieves frequent urge to urinate"
• "Staphysagria 6X HPUS …Relieves inability to empty bladder"
You also use metatags to bring consumers to your website. Examples of your metatags include, "sciatica," "tinnitus,""ringing in the ears," "fibromyalgia," and "diabetic neuropathy."
Based on the above-mentioned claims on your website, "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets" are drugs as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. §321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Based on the claims on your website, your products "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets" are intended to treat diabetic neuropathy, fibromyalgia, sciatica, tinnitus, and urinary incontinence, and/or symptoms caused by those diseases or conditions. Section 503(b)(1) of the FD&C Act [21 U.S.C. §353(b)(1)] identifies criteria for determining the prescription status of a product. Your products "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets" are prescription drugs within the meaning of section 503(b)(1) of the FD&C Act, because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Because they are subject to §503(b)(1) of the FD&C Act, "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets" are misbranded under section 503(b)(4) of the FD&C Act [21 U.S.C. §353(b)(4)] in that their labels fail to bear the symbol, "Rx only." 1 The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
We recognize that "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets"are represented as being homeopathic drugs with active ingredients measured in homeopathic strengths. The definition of "drug"in section 201(g)(1) of the FD&C Act [21 U.S.C. §321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
Other Unapproved Drugs and Misbranded Drugs
FDA also reviewed labeling claims for your products "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Fat Dissolver Cream," "Lung Cream," "Sciatica Pain Relief Cream," and "Shingles Recovery Cream." According to the labeling claims you make for "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Fat Dissolver Cream," "Lung Cream,""Sciatica Pain Relief Cream," and "Shingles Recovery Cream," they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of such labeling claims found on your website include, but may not be limited to, the following:
Diabetic Foot Cream
• "Diabetic Foot Cream"
• "Anti-Itch Formula"
• "One out of every three people with diabetes will be affected by skin disorders caused by diabetes. Fortunately, most skin conditions can be prevented or easily treated if caught in the early stages. It is important to maintain healthy skin with skin care products specifically developed for people with diabetes."
• "[P]rotect against infections."
• "I am a diabetic and the Diabetic Foot Cream was the first medicine I got that really … helped my legs and feet."
• "[T]his cream heals alot of conditions. I think I still have feet and legs because of it."
Diabetic Hand & Body Cream
• "Diabetic Hand & Body Cream"
• "Anti-Itch Formula"
• "One out of every three people with diabetes will be affected by skin disorders caused by diabetes. Fortunately, most skin conditions can be prevented or easily treated if caught in the early stages. It is important to maintain healthy skin with skin care products specifically developed for people with diabetes."
Fat Dissolver Cream
• "Fat Dissolver Cream"
• "Lose one pant size in 28 days! Fat Dissolver Cream contains active ingredients proven in clinical studies to have slimming effects."
• "Algae extracts break up fat cells, limit the production of new fat cells, and eliminate fats by flushing and draining."
Lung Cream
• "Lung Cream"
• "Breathe Easier! Lung Cream works in minutes to help relieve wheezing and shortness of breath caused by bronchitis, asthma, emphysema, and smoker’s cough."
• "Powerful herbal formula contains special ingredients known to help thin chest mucus, control coughing and phlegm buildup, and restore normal breathing."
• "In just minutes you will notice an improvement in breathing difficulties due to bronchitis, asthma, emphysema, and smoker‘s cough."
• "Ophiopogon…Strengthens respiratory membranes."
• "I have suffered from asthma for over 30 years …I have used the lung cream for two days and have noticed a drastic improvement."
Sciatica Pain Relief Cream
• "Sciatica Pain Relief Cream"
• "Sciatica pain in the lower back? Sciatica Relief Cream helps relieve persistent, shooting pains, numbness, and tingling associated with the sciatic nerve …"
• "Gnaphalium Polycephalum Extract …For symptoms of sciatica with numbness and pain"
• "Capsicum …For burning pains and when sciatica is worse ..."
• "Magnesium Phosphate … For radiating painsand numbness associated with Sciatica"
Shingles Recovery Cream
• "Shingles Recovery Cream"
• "Anti-Itch Formula"
• "MagniLife Shingles Recovery Cream can help relieve the pain, inflammation, and itching associated with an outbreak of shingles."
• "My husband has been suffering from Shingles for years now ...When I saw your ad I thought anything to relieve his pain and discomfort was worth a try. HE NOW HAS RELIEF!"
• "Your Shingles Cream really works! Imagine the joy I felt when my breakout disappeared."
• "I have been using your product for my rash and saw results almost immediately."
Based on the above-mentioned claims for "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Fat Dissolver Cream," "Lung Cream," "Sciatica Pain Relief Cream," and "Shingles Recovery Cream," they are drugs as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Fat Dissolver Cream," "Lung Cream," "Sciatica Pain Relief Cream," and "Shingles Recovery Cream" are also "new drugs," as defined in section 201(p) of the FD&C Act [21 U.S.C. §321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There are no FDA-approved applications for these products. Therefore the marketing of these products constitutes a violation of these provisions of the FD&C Act.
In addition, "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Lung Cream," "Sciatica Pain Relief Cream," and "Shingles Recovery Cream" are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. §352(f)(1)], because the labeling for these drugs fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR §201.5]. Your above-mentioned products are offered for conditions, such as (but not limited to), skin disorders associated with diabetes, emphysema, sciatica, and shingles, which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use the above-mentioned products safely for their intended uses. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§201.100(c)(2) and 201.115]. Because "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Lung Cream," "Sciatica Pain Relief Cream," and "Shingles Recovery Cream" lack FDA-approved applications, they are not exempt under 21 CFR §§201.100(c)(2) and 201.115. For these reasons, these products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C.§ 352(f)(1)]. The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
We recognize that the labeling on your website refers to your product "Sciatica Pain Relief Cream" as a homeopathic cream. The CPG defines a homeopathic drug as any drug labeled as being homeopathic which is listed in the HPUS, an addendum to it, or its supplements, and which has potencies specified in terms of dilution, e.g., 1X, 2X. The labeling for "Sciatica Pain Relief Cream" does not list active ingredients measured in homeopathic strengths and to our knowledge not all listed active ingredients are recognized in the HPUS, an addendum to it, or its supplements. Therefore, "Sciatica Pain Relief Cream" is not considered a homeopathic drug product under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to "Sciatica Pain Relief Cream."
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Mr. Ta at 214-253-5217.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
cc: Texas Department of State Health Services
Attn: Tom Brinck, Manager
Drugs and Medical Devices Group MC 1987
Policy, Standards and Quality Assurance Unit
PO Box 149347
Austin, TX 78714-9347
1 The Agency’s guidance, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)," states that, in accordance with § 503(b)(1) of the FD&C Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, "Caution: Federal law prohibits dispensing without prescription." This guidance was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended § 503(b)(4) of the FD&C Act to require that the label of a prescription drug must bear, at a minimum,the symboi "Rx only."
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This page was posted on August 12, 2017.
