• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

From Fatigued to Fantastic, LLC 4/18/12

  

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

Public Health Service
Food and Drug Administration
 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 1 01
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5705
Fax: (410) 779-5705

WARNING LETTER
CMS # 273358

April 18, 2012

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Jacob Teitelbaum, M.D.
From Fatigued to Fantastic, LLC
7 Benmere Road
Glen Burnie, MD 21060-7235

Dear Dr. Teitelbaum:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.endfatigue.com in February 2012 and has determined that your products "Corvalen (D-Ribose)", "Coenzyme Q10", "Jigsaw Magnesium w/ SRT'', ''BMR Complex (Thyroid Glandular)", "Energy Revitalization System", "Acetyl-L-Carnitine", "Chol-less", "Thymic Protein", "Alpha Lipoic acid", "Black Cohosh", "Healthy Knees and Joints", and "Eskimo 3 Fish Oil" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

We noted that on the webpage titled, "Cures A-Z," you list a number of medical conditions with information on how to treat these conditions with products offered for sale through your website. For example:

On the webpage titled, "Alzheimer's Disease," under the heading, "TREATMENT," the following product is recommended:

• "Eskimo 3 Fish Oil"

On the same webpage, you also include the following claim for this product:

• "[C]an also help treat any hidden depression which may be present."

On the webpage titled, "Breast Cancer," under the heading, "TREATMENT," after the claim "[E]arly experience showed these nutrients may decrease breast cancer growth ... " the following products are recommended:

• "Coenzyme Q10"

On the same webpage, you also include the following claim for this product:

• "[I]n 1 study, it helped shrink breast cancer metastases."

• "Black Cohosh"

On the same webpage, you also include the following link for this product:

• "Black Cohosh May Decrease Breast Cancer Risk by Half While Preventing Cancer Recurrence"

On the webpage titled, "Diabetes," under the heading, "TREATMENT," and the subheading, ''Recommended Supplements," the following products are recommended:

• "Alpha Lipoic acid"

On the same webpage, you also include the following claim for this product:

• "Benefits: . .. .If you have active Hepatitis or Cirrhosis, consider taking 300-2,000mg a day, depending on its severity. It has been shown to be helpful for Diabetic Neuropathy ... "

• "Acetyl-L-Carnitine"

On the same webpage, you also include the following claim for this product:

• "If you have diabetic nerve injury, add acetyl-1-camitine ... "

On the webpage titled, "Cold and Flu," under the heading, "TREATMENT," and the subheading, "Recommended Supplements," the following product is recommended:

• "Thymic Protein (ProBoost)"

On the same webpage, you also include the following claim for this product:

• "Take as directed 3 times each day at the first sign of any infection until the infection resolves."

On the webpage titled, "Avoiding and Treating Infections without Antibiotics," you make the following additional claims for the product:

• "Take natural thymic hormone. This is available as a product called ProBoost .... Taken at the first sign of a respiratory infection, it usually nips the infection in the bud, eliminating it in 12-36 hours."

• "I have found that using it for 1-3 days at the onset of an infection can shorten the length of the infection dramatically, and most often stops it on the first day."

On the webpage titled, "High Cholesterol," under the heading, "TREATMENT," and the subheading, "Recommended Supplements," the following product is recommended:

• "Chol-less," which consumers access through a link titled, "Herbals that reduce cholesterol"

On the webpage titled, "Hypertension," under the heading, "TREATMENT," and the subheading, "Recommended Supplements," the following products are recommended:

• "Coenzyme Q10"

On the same webpage, you also include the following claim for this product:

• "I have seen it lower blood pressure as much as 30 to 40 points in some severe cases."

On the webpage titled, "Parkinson's Disease," under the heading, "TREATMENT," you make the following claim:

• "There are a host of devastating neurologic disorders that can improve significantly with natural therapies."

Under the subheading, "Recommended Supplements," the following products are recommended for Parkinson's Disease:

• "Jigsaw Magnesium w/ SRT"

• "Energy Revitalization System"

The following products are recommended in combination for treatment of Heart Disease on your webpages titled "Heart Disease" and "Treating Heart Problems Naturally," either by name or via a link to the page where the product can be ordered.

• "Corvalen (D-Ribose)"
• "Coenzyme Q10"
• "Jigsaw Magnesium w/ SRT"
• "BMR Complex (Thyroid Glandular)"
• "Energy Revitalization System"
• "Acetyl-L-Carnitine"

On the webpage titled, "Heart Disease," under the heading, "TREATMENT," you make the following claim for this group of products:

• "The following recipe [referring to the six products, which are listed under the "Recommended Supplements" heading that follows] can help anyone with heart disease ... "

On the webpage titled, "Treating Heart Problems Naturally", you again reference the above mentioned combination of products as treatment for Heart Disease. Specifically, you describe them as "key treatments" for angina, heart attacks, congestive heart failure, heart valve problems, and abnormal heart rhythms (arrythmias).

On the webpage titled, ''Herbal Beats Pain Medication in New Arthritis Study," you make the following claim:

• " ... natural remedies and other drugless treatments have been shown to be far more effective than NSAIDS at treating arthritis .. . [D]octors are continuing to prescribe deadly NSAIDs when all-natural, safe, lower cost, and more effective alternative treatments like Healthy Knees and Joints are available."

Your products "Corvalen (D-Ribose)", "Coenzyme Q10", "Jigsaw Magnesium w/ SRT", "BMR Complex (Thyroid Glandular)", "Energy Revitalization System", "Acetyl-L-Carnitine", "Chol-less", "Thymic Protein", "Alpha Lipoic acid", "Black Cohosh", and "Eskimo 3 Fish Oil" are not generally recognized as safe and effective for the above referenced uses and therefore are "new drugs" under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. The unlawful disease treatment and prevention claims made on your website were too numerous to list in this letter. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

In addition, we also note that you use your Facebook account (accessible at
http://www.facebook.com/#!/DrTeitelbaum) to promote your products for disease treatment and prevention through references and links to disease claims for the products on your website.

• In a post dated January 27, 2012, you stated "This week I discuss natural treatments (and prevention) for heart disease." In that post, you also include a link titled, "To Prevent Heart Disease, Rely on Natural Medicine," which links to your www.endfatigue.com website. The webpage accessible through that link includes similar claims as noted above, as well as most of the same recommended products to prevent and treat heart disease.

• In a post dated November 30, 2011, you stated "I look at a new study showing that an herbal can beat the pants off a pain medication when managing arthritis." In that post, you also include a link titled, "Herbal Beats Pain Medication in New Arthritis Study," which links to your www.endfatigue.com website. The webpage accessible through that link includes the claim described above for your Healthy Knees and Joints product.

You should respond in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.

Please send your reply to the U.S. Food and Drug Administration, Attention: Evelyn Bonnin, District Director, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Kristy Leslie at (757) 483-7042.

Sincerely,

/S/

Evelyn Bonnin
District Director
Baltimore District Office

cc:
  Jacob Teitelbaum, M.D.
  466 Foreland Road
  Annapoiis, MD 21401