U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. American Botanical Pharmacy - 562180 - 10/30/2018
  1. Warning Letters

WARNING LETTER

American Botanical Pharmacy MARCS-CMS 562180 —

Product:
Biologics
Cosmetics
Drugs
Blood Products
Gene Therapy
Deodorant
Face Paint
Antibiotic Resistance
Compounding
Issue:
Topics
Premarket
Public Awareness

Recipient:
Recipient Name
Dr. Richard Schulze
American Botanical Pharmacy

4114 Glencoe Ave

Marina del Rey, CA 90292
United States

Issuing Office:
San Francisco District Office

United States


WARNING LETTER

 

 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

 

October 30, 2018                                                                                                                WL # 562180

 

American Botanical Pharmacy

Attn: Dr. Richard Schulze

4114 Glencoe Ave

Marina del Rey, CA  90292

 

Dear Dr. Schulze:    

                                   

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at www.herbdoc.com, as well as your Facebook page, https://www.facebook.com/AmericanBotanicalPharmacy, which contains a link to your website at www.herbdoc.com. Based on the review of your firm’s website and your firm’s Facebook page, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.

 

Unapproved New Drugs/Misbranded Drugs

 

FDA reviewed your web site at www.herbdoc.com in September 2018 and has determined that you take orders there for your products Cold & Flu Herbal “SHOT”, Intestinal Formula #1, Male Formula, 5-Day Liver Detox, the Incurables Program, and SuperFood Plus. FDA also reviewed your Facebook page, https://www.facebook.com/AmericanBotanicalPharmacy, which contains a link to your website at www.herbdoc.com.  The claims on your firm’s website and Facebook page establish that these products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

 

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act.

 

Examples of the claims on your website, www.herbdoc.com, that provide evidence that your products are intended for use as drugs include:

 

 

Under Cold & Flu Herbal “SHOTwebpage:

 

  • “Dr. Schulze’s Cold & Flu Herbal “SHOT”! GETTING SICK? STOP IT QUICK! At the first sign of that “uh-oh” feeling, take a heroic dose of herbs—Dr. Schulze’s Cold & Flu Herbal “SHOT”—and do it IMMEDIATELY! Use two, three or up to six bottles a day, whatever it takes to STOP that cold or flu DEAD in its tracks.”

 

  • “THE ULTIMATE WEAPON TO STOP A COLD OR FLU!”

 

  • “Or, just take 1.5 ounces straight, gargle, swallow it and you have the perfect treatment for a cold or flu.”

 

Your website on the Cold & Flu Herbal “SHOT” webpage also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Cold & Flu Herbal “SHOT” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

 

  • “Feeling Better After 10 minutes!

My grandkids infected me with the flu. A friend stopped by with a box of your Cold & Flu Herbal ‘SHOTS’…and once again, I was amazed that within 10 minutes I was on the mend. In an hour, it was as if I never was ill. Thank you for your fight to keep these products available.”

 

Under Incurables Program webpage:

 

Your Incurables Program webpage on your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Incurables Program for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

 

  • “The Doctor was Shocked!

I had Stage 2 breast cancer and Stage 3 colon cancer. The doctor told me I wouldn’t make it to 2005. I did the Incurables Program twice and went back to the doctor – he was shocked! As of 2016, I have 17 grandchildren and keep up the cleansing!”

 

  • “You Saved My Life!

Two years ago, my sister showed up on my doorstep with a frantic look on her face.… I was 400 pounds and had just been diagnosed with Sarcoidosis, Obstructive Sleep Apnea and my Asthma was threatening to take my life away. Long story short, I did the Incurables Program. You saved my life, Dr.  Schulze.…”

 

  • “Doctors Are Pleased And Surprised!

I had lung cancer. After using the Incurables Program, 2 tumors shrunk and the biggest one, doctors can’t even detect the size anymore. Doctors are pleased and surprised – I’ve ordered another kit!”

 

 

  • “From Cervical Cancer to Pregnancy!

I am 50 years old and was diagnosed with Cervical Cancer when I was 38 years old. A friend of mine was using Dr. Schulze’s products and got me on the Incurables Program. After eight months, my cone biopsy was negative and I was able to get pregnant and gave birth two years later.”

 

Under the SuperFood Plus webpage:

 

  • “Plant-based SuperFoods provide health benefits beyond their nutritional components, often working synergistically to… fight disease…”

 

  • “SuperFoods can provide…disease fighting…”

 

Your Superfood Plus webpage on your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Superfood Plus for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

 

  • “Healed From Dementia, Alzheimers [sic], Depression, and Anxiety!

I have using Superfood for years and I have had amazing results…. After five years I noticed I never got sick. No more sinus infections; no more flu! My father was suffering from dementia, Alzheimers [sic], depression and anxiety after heart surgery. I convinced my mother to start giving him Superfood and stop all the medications. After one month he recovered completely and was back to his lovely self. Thank you, Dr. Schulze!”

 

  • “Healed From Chemo!

I was in chemo 3 years ago. I could never even get up and make some tea. After I took SuperFood, in 2 days I was cooking all meals and in 2 weeks I was driving myself to the supermarket....”

 

  • “No Longer Diabetic!

My daughter introduced SuperFood Plus to me. I started taking it in May. I was amazed with the benefits I got from it. I … am no longer diabetic.”

 

Furthermore, claims made on your Facebook page at www.Facebook.com/AmericanBotanicalPharmacy, which provides a link to your website at www.herbdoc.com, provide additional evidence that your products are intended for use as drugs: 

 

Posts by your company on your Facebook timeline page include the following:

 

  • On July 25, 2018: “My Male formula stimulates male sexual performance, stamina, strength and power. No need for Viagra!”

 

  • On May 10, 2018: “Watch my 5-Day LIVER Detox video to learn how to… clean your blood of unhealthy accumulated toxins…. #DrSchulze #herbdoc… #LiverDetox… #5DayDetox”

 

 

  • On March 7, 2018: “Check out how Mona utilized Dr. Schulze’s Incurables Program to support her healing from Multiple Myeloma.... #DrSchulze #HerbDoc #IncurablesProgram #ChrisBeatCancer” Links to webpage www.chrisbeatcancer.com

 

Additionally, FDA reviewed a document listed on your Facebook page titled “The 2018 Herbal Product Catalog.”  This document includes an order form for your products and refers readers to your website at www.herbdoc.com.  Your product catalog also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Intestinal Formula #1 product for the cure, mitigation, treatment, or prevention of disease.  Examples of such testimonials include:

 

  • Pg. 35: “DOCTOR RECOMMENDED!

I have had Diverticulitis for the past several years. Last August, I asked my doctor, who had colon cancer surgery, what he took to regulate his bowels. He told me about Intestinal Formula #1. I started taking it and I feel just great! No more stomach pains and for the first time in my life, I am regular.”

 

  • Pg. 35 “FORMULA #1 SAVED ME AFTER MY COMA!

I came out of a coma and for eighteen years, I could not have a bowel movement on my own without pain and much time between. Doctors couldn’t find anything wrong with me. I took the Intestinal Formula #1 and the very next morning went to the bathroom and had soft stools with no pain. It is amazing!”

 

Your Cold & Flu Herbal “SHOT”, Intestinal Formula #1, Male Formula, 5-Day Liver Detox, Incurables Program, and SuperFood Plus products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 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.

 

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5).  Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

 

Your Male Formula and your Incurables Program, which includes your SuperFood Plus and Intestinal Formula #1 products, as well as your SuperFood Plus product by itself are intended    for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Incurables Program and SuperFood Plus products fail to bear adequate directions for      their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

 

Misbranded Dietary Supplements

 

Even if your website, www.herbdoc.com, and associated Facebook page did not contain claims that cause your SuperFood Plus product to be an unapproved new and misbranded drug, this product would still be a misbranded food under section 403 of the Act [21 U.S.C. § 343] in that the label for this product does not comply with the labeling requirements in 21 CFR 101, as follows:

  1. Your SuperFood Plus product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take five (5) tablets three times a day, but the serving size lists 15 tablets. The serving size listed should be the maximum number of tablets per eating occasion, which is 5 tablets.

 

  1. Your SuperFood Plus product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 § 343(q)(5)(F)] in that the presentation of the nutrition information (“Supplement Facts”) on the label of your product does not comply with 21 CFR 101.36. For example:

 

  • The product label declares saturated fat and cholesterol with an amount of zero. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).

 

  • The product label bears an incorrect %DV for total fat based on the quantitative amount declared per serving. For dietary ingredients for which DRV's have been established, "Less than 1%" or "<1%" shall be used to declare the % Daily Value when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the % Daily Value when rounded to the nearest percent is zero. [21 CFR 101.36(b)(2)(iii)(C)]

 

  • The product label bears an incorrect %DV for calcium based on the quantitative amount declared per serving in accordance with 21 CFR 101.9(c)(8).

 

  • The product label declares the dietary ingredient “unsaturated fat.” This dietary ingredient must be designated as either “polyunsaturated fat” or “monounsaturated fat” in accordance with 21 CFR 101.9(c)(2)(iii) and (iv). Furthermore, a Daily Value has not been established for either of these types of unsaturated fat; therefore, a %DV must not be listed. Lastly, “polyunsaturated fat” and “monounsaturated fat” must be indented under total fat. Likewise, dietary fiber must be indented under total carbohydrate.

 

The violations cited in this letter are not intended to be an all-inclusive list 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 ensure that all products marketed by your firm comply with the Act and its implementing regulations.

 

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.

 

We offer the following comments:

 

  1. The label’s information panel includes nutrition or ingredient information intermingled with information that is considered intervening material. Examples of intervening material are the statements of “(approx 40% protein)” in the Supplement Facts label and “Dr. Schulze’s Proprietary Non-Fermentable” in the ingredients statement. All information appearing on the information panel of the product label should appear in one place without other intervening material. [21 CFR 101.2(e)]

 

  1. The heading “Superfood Plus Supplement Facts” is not in accordance with 21 CFR 101.36(b)(1).

 

  1. The column heading “% RDI Value” in not in accordance with 21 CFR 101.36(b)(2)(iii)(A).

 

  1. The product label declares the dietary ingredients “niacin (vitamin B3)” and “pantothenic acid (vitamin B5),” but vitamin B3 and vitamin B5 are not synonyms specified for niacin or pantothenic acid in 21 CFR 101.9 or 101.36(b)(2)(i)(B).

 

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete corrective action within fifteen working days, please explain the reason for the delay and the date by which you will make the correction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

 

Your response should be sent to U.S. Food and Drug Administration, Sara J. Dent Acosta, Compliance Officer, Food and Drug Administration, Office of Human and Animal Foods Division West 5.  If you have any questions with regard to this letter, please contact Sara J. Dent Acosta at (619) 941-3767 or email sara.dent@fda.hhs.gov. Refer to Unique Identification Number 562180 when replying.

 

Sincerely,

/S/

Darla Bracy, Division Director

Office of Human and Animal Foods

Division 5 West

 

 

 

cc:      

Benson Yee

Chief, Food and Drug Branch

California Department of Public Health

1500 Capitol Avenue, MS-7602

P.O. Box 997435

Sacramento, CA  95899-7435