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Enforcement Actions

Panacea Products, LLC 24-May-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New Orleans District
Southeast Region
404 BNA Drive, Building 200, Suite 500
Nashville, TN 37217

Telephone: 615-366-7801
FAX: 615-366-7802


May 24, 2007

WARNING LETTER NO. 2007-NOL-11

HAND DELIVERED

Barbara Brierre, CEO
Panacea Products, LLC.
1720 Kaliste Saloom Road, Suite B-2
Lafayette, LA 70508

Dear Ms. Brierre:

This letter concerns your firm's marketing of the products SEABLUE Balance, SEABLUE Power, SEABLUE Vigor, SEABLUE Calm, and SEABLUE Strength on your websites, www.panaceacreams.com and www.seablue.com. According to information on your websites, your "Transdermal Vitamin Therapy" products are intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on your websites documenting these intended uses include, but are not limited to, the following:

General Website Statements Regarding SEABLUE Products:

"SEABLUE™ vision - to balance the body's vitamin deficiencies with an effective and easy-to-administer solution proven to aid in the prevention and treatment of heart disease, cancer, osteoporosis, diabetes, high blood pressure, and many other chronic diseases."

[Your website indicates SEABLUE contains magnesium.]

"A positive influence of magnesium in the prevention and treatment of hyperactivity in children is more and more frequently raised in the literature. The aim of our work was to estimate magnesium contents in children with ADHD. The investigations comprised 116 children (94 boys and 20 girls), aged 9-12 years, with recognized ADHD. In 68 out of 116 patients examined ADHD occurred with other coexisting disorders specific to the developmental age and in the remaining 48 patients it occurred together with disruptive behavior. Magnesium deficiency was found in 95% of those examined, most frequently in hair (77.6%), in red blood cells (58.6%), and in blood serum (33.6%) of children with ADHD. The conclusion from the investigations is that magnesium deficiency in children with ADHD occurs more frequently than in healthy children."

"It is known that magnesium supplementation not only benefits, but is vitally important in the treatment of diabetes type 1, diabetes type 2, insulin resistance, hypertension, hyperlipidemia, cardiovascular disease including coronary artery disease and cardiac arrhythmias."

• "Magnesium intake may protect against diabetes and CVD in part through reducing low-grade inflammation."

"One study demonstrates that a daily supplement of 300 to 600 mg of magnesium results in tremendous improvements in the number and severity of tender points."

"Without sufficient intake of magnesium, we cannot expect normal blood pressure. In higher doses, magnesium has been found to reduce high blood pressure."

"[Magesium] is known to treat abdominal cramps and constipation and therefore is used to treat irritable bowel syndrome."

"Some doctors believe that the ratio of calcium to magnesium in the diet is important. Patients, who having one or more bouts of calcium oxalate stones, are often instructed to take a daily magnesium supplement. A study has shown that of 149 kidney stone patients who took a daily 300 mg magnesium supplement over a 4 1/2 to 6 year period, 90% had no stones during this period. It is theorized that magnesium helps prevent calcium oxalate from [crystalizing]."

"Several studies have shown that a high percentage of people with mitral valve prolapse have lower than normal magnesium levels. One study by researchers at the University of Alabama School of Medicine in Birmingham found that supplemental magnesium relieved many of the symptoms associated with this disorder. . . Overall there was a 90% decrease in muscle cramps, 47% decrease in chest pain and a decrease in blood vessel spasms. Additionally, the people studied experienced less palpitations, less cardiac arrhythmias, fewer migraines, less fatigue. In a study reported in the American Journal of Cardiology, magnesium supplementation was effective in decreasing the level of anxiety caused by the overactivity of the sympathetic/adrenergic nervous system."

"Accordingly, studies have demonstrated a role for magnesium in the prevention and treatment of osteoporosis."

"Magnesium as an effective medical therapy for treating preeclampsia, asthma, ischemic heart disease, and cardiac arrhythmias has been reported."

SEABLUE Balance

"SEABLUE™ Balance, Dermal Vitamin Therapy for Women. . . Ingredients: This formula contains magnesium chloride, zinc chloride, B-6 (Pyridoxine HCL), B-12 (Cyanocobalamin) and Progesterone 2% cream."

• "SEABLUE™ Balance helps provide long term relief from the symptoms of hormone imbalance such as fatigue, anxiety, insomnia, PMS, hot flashes, moodiness, heart palpitations, constipation, and migraines."

"Natural progesterone is an important hormone in women because it helps to balance the estrogen present in the body. It also protects against endometrial and breast cancer, helps prevent weight gain and water retention, enhances the body's capacity to use and eliminate fats, promotes new bone formation, has a positive effect against high blood pressure and improves sex drive."

"Progesterone acts as an anti-inflammatory agent and reduces the immune response. Other effects include normalizing blood clotting and vascular tone. . . Progesterone also assists in thyroid function and bone building by osteoblasts. As an estrogen antagonist, progesterone appears to prevent endometrial cancer (involving the uterine lining) and breast cancer."

"I was having real bad migraines and loosing sleep. . . I started using SEABLUE™ and it helped me get off my prescription medication. . . . "

"45 yowf with a long history of endometriosis, and tubal ligation after the birth of her second child (presently 13 years old). She had multiple complaints, including headaches, anxiety, moodiness, insomnia, fatigue, forgetfulness, irritability, water retention, weight gain, heart palpitations, swollen and painful breasts, cramps, and heavy menses. Hot flashes and night seats [sic] were moderate. She began the SEABLUE™ Balance for Women using it twice a day, and within a month, almost all of her symptoms had either improved or resolved. She added that over time of using the SEABLUE™ Balance for Women, that she had noticed her hair loss had stopped, and her skin was better - no more breakouts. At 4 months time, she stated that she was feeling like her old self again."

SEABLUE Power

• "Targeted vitamins also help lower homocysteine levels, which lessens the risk of developing heart disease and Alzheimer's disease."

"I use to have to go to the doctor for B-12 injections in my arm. . . since using SEABLUE™ I've completely [had to] stop getting these injections. . . ."

"21 yowm, underwent gastric by-pass surgery at age 17 for weight loss. He has subsequently gone from 395 lbs. to 1801bs. over the last three years. He presented with fatigue, numbness in both arms, muscle twitching predominantly both legs and cheeks of face, muscle cramps in bottom of both feet and calves, especially at night. After using the SEABLUE™ Power with B-12 formula for 2 months, lie first noticed improvement in energy during the day. Next, resolution of numbness, muscle twitching, and muscle cramps. Also, much improved sleep and improvement in digestive tolerance to foods since being on the formula. Being young, he has tried to discontinue the formula several times for a couple of days, and all above symptoms returned. He had always refused B12 shots, tried sublingual B12 with no results, also tried bariatric vitamins, but discontinued because of chalky taste and inconvenience of taking them multiple times a day."

SEABLUE Vigor

"For the alleviation of symptoms including. . . anxiety, depression, insomnia, andropause, enlarged prostate. . ."

"DHEA supplements are said to. . . prevent a variety of conditions associated with aging, including osteoporosis, arthritis, hardening of the arteries, and cancer. DHEA is also currently being studied for its possible use as a treatment for autoimmune diseases, such as chronic fatigue syndrome and lupus."

"There have been several small studies performed that indicate DHEA may help treat numerous other disorders as well, including Crohn's disease, depression, menopause, myotonic dystrophy, irregular menstrual cycle, schizophrenia, and erectile dysfunction, to name a few."

SEABLUE Calm

• "Benefits:

o Prevent & treat heart disease, including angina and irregular heartbeat (arrhythmia[C]ontrol high blood pressure)
o Limit complications of congestive heart failure
o Prevent diabetes complications
o Reduce the symptoms of fibromyalgia
o Protect against migraines. . .
o Minimize the severity of asthma attacks[.]
o Prevent osteoporosis
o Reduce emotional irritability in chronic depression, anxiety, and panic disorder
o Alleviates symptoms of Mitral Valve Prolapse. . .

"PVCs or Pre Ventricular Contractions have been a part of my life for at least 30 years . . . Beta blockers and otherprescribed medications had limited success in reducing the frequency of my PVCs. I had read that magnesium supplements often had a helpful effect and oral magnesium capsules helped a little. I was given a bottle of SEABLUE™ Calm with Magnesium to try and in less than a week the frequency of my PVCs was dramatically reduced."

SEABLUE Strength

• "Benefits:

o Prevent bone loss and osteoporosis
o Improve bone density
o Benefits high blood pressure
o Prevents pre-eclampsia
o Benefits lowering of cholesterol and triglycerides
o May benefit prevention of cancers of the endometrium, colon, and pancreas
o May benefit insomnia
o Calcium benefits PMS"

SEABLUE Balance, SEABLUE Power, SEABLUE Vigor, SEABLUE Calm, and SEABLUE Strength are drugs, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. Moreover, these products are new drugs, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for their labeled uses.

Your website indicates, "SEABLUE™ uses the transdermal method of application because it gives you an amazing 95% absorption rate of the nutrients directly to your body's circulation! When applied to the skin, the vitamins are transported across the skin barrier, straight into the cells in the bloodstream - exactly where they benefit you most. The nutrients are rapidly and consistently dispersed throughout your body, giving you maximum benefit with minimum dosage."

FDA's regulations at Title 21, Code of Federal Regulations (21 CFR), § 310.3(h)(5) state a drug may be considered a new drug because of the newness of its dosage form or the method or duration of administration or application suggested in its labeling. FDA considers all transdermal drug delivery products to be new drugs under Section 201(p) of the Act because a transdermal delivery system for a drug is not generally recognized by experts to be safe and effective for any uses. Therefore, SEABLUE Balance, SEABLUE Power, SEABLUE Vigor, SEABLUE Calm, and SEABLUE Strength also are new drugs because they are administered through a transdermal delivery system.

Additionally, SEABLUE Balance, an over-the-counter (OTC) topical progesterone containing product promoted for drug use is a new drug under the final rule on OTC topical hormone products, 21 CFR § 310.530(b).

Under Sections 301(d) and 505(a) of the 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 it has an FDA-approved application in effect. Your sale of the above-listed "Transdermal Vitamin Therapies" without approved applications violates these provisions of the Act.

Furthermore, many of the conditions for which these products are offered, such as asthma, cancer, cardiovascular disease, diabetes, heart disease, high blood pressure, hyperlipidemia, irritable bowel syndrome, preeclampsia, and osteoporosis are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so a layman can use these drugs safely for these intended purposes. Each product's labeling fails to bear adequate directions for these intended uses, causing each product to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

Moreover, you make false and misleading statements on your website regarding your products. For example, the "Frequently Asked Questions" section includes the question, "[Is] SEABLUE™ creams FDA approved?" Your website states "SEABLUE™ products are manufactured at an FDA approved facility in Bronsville, TX." However, FDA does not approve facilities, and your products are not the subject of FDA-approved applications. Thus, your products are misbranded under Section 502(a) of the Act, 21 U.S.C. § 352(a).

The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure the drug products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses which violate the Act also may be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps you have taken to correct the above-listed violations and to assure similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, TN 37217, Attention: Kari L. Batey, Compliance Officer.

A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District

Enclosure: Warning Letter No. 2007-NOL- 11, dated May 10, 2007

cc:
Malcolm J. Broussard
Executive Director
Louisiana Board of Pharmacy
5615 Corporate Blvd, Suite 8E
Baton Rouge, LA 70808-2537