Inspections, Compliance, Enforcement, and Criminal Investigations

Dr. Dennis Black 5/4/15

  

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

Public Health Service
Food and Drug Administration
 Dallas Drstrict
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

May 4, 2015
 
2015-DAL-WL-14
 
WARNING LETTER
 
UPS Overnight
 
Dennis W. Black, President
Dr. Dennis Black, LLC.
2387 Midway Road
Carrollton, Texas 75006
 
Dear Mr. Black:
 
Investigators with the United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 2387 Midway Road, Carrollton, Texas, from February 26, 2014 through March 6, 2014.  Based on our inspection and subsequent review of your product labeling collected during the inspection, as well as your firm’s website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations.   
 
You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
 
Unapproved New Drugs
 
The FDA reviewed your websites, www.drdennisblack.com and www.texassuperfood.com, in August of 2014 and January of 2015, and has determined that you take orders there for the products  “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Cleansing Combo Pak,” “Supersilver Solution,” “Royal Tea,” “Omega Oil 3•6•9,” “Probio Boost,” “CleanseMax,” “ParaMax Cleanse,” and “Heavy MetalMax” which the websites promote for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites establish that the products are drugs 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 for such uses violates the Act.
 
Examples of some of the claims on your website, www.drdennisblack.com, that provide evidence that your products are intended for use as drugs include:
 
“Cleansing Combo Pak”:
  • “Cleanse your body, liver, and digestive tract of parasites, yeast overgrowth, and toxins…”
 
“Supersilver Solution”:
  • “[F]rom quickly healing wounds to its… capable of eradicating fungal organisms on any surface, within the body, or… The uses of a natural antimicrobial, antiviral, and antifungal spray are endless…”
  • “Stimulate rapid healing of destroyed or infected tissue…”
 
Royal Tea”:
  • “Royal Tea blend…powerful compounds proven to help even cancer…”
 
Omega Oil 3•6•9”:
  • “Increased levels of Omega 3 and 6 have been shown to have a suppressive effect on cardiovascular disease, cancer, inflammatory and autoimmune diseases, rheumatoid arthritis, and asthma…”
 
Probio Boost”:
  • “[P]robiotics can be used to improve disease prevention”…”
 
CleanseMax”:
  • “Eradicates constipation issues…”
 
ParaMax Cleanse”:
  • “[P]atented anti-microbial, anti-parasitic, anti-fungal ParaMax formula is designed to eradicate parasites and candidiasis, creating an unwelcoming setting for parasitic organisms…”
  • “[I]mpotence, cysts, fibroids…”
  • “Paralyzation of parasites…Complete removal of parasitic organisms…Removal of yeast and fungal organisms from natural extracts…Eradication of negative digestive fungus and overgrowths, such as Candida albicans…”
 
Heavy MetalMax”:
  • “[A] simple way to eradicate toxic heavy metals…chelating herbs to eliminate heavy metals…”
  • “[F]rom the lead in auto exhaust, the cadmium in cigarettes and soft drink dispensers. Picture the relief of wiping out other toxic metals like mercury in dental fillings and copper in water heaters and hormone pills...”
  • “Eliminate accumulated heavy metals…”
 
Your website, www.drdennisblack.com, also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
Superfood Single”:
On the webpage titled “Reviews”:
  • “[H]ave allergy symptoms when I go to work in the yard…”
  • “[I]s diabetic and gets headaches all the time. We thought it was from food with gluten in it. She’s been taking Superfood for 5 months now and she doesn’t get headaches, even when she eats food with gluten…”
  • “[M]y chronic reflux seems to have subsided…”
  • “[F]ix my heart burn issues…with acid reflux…”
 
Superfood Double”:
On the webpage titled “Reviews”:
  • “[M]y fibromyalgia has not been as bad…I definitely recommend for Fibro and Chronic Fatigue…”
  • LOWER MY CHOLESTEROL… LOWER MY BLOOD PRESSURE…”
  • “[H]elps with cholesterol…”
 
Superfoods Family”:
On the webpage titled “Reviews”:
  • “I have diabetes, allergies…”
  • “My…chronic pain not so chronic anymore…”
 
Superfood Family Powder”:
On the webpage titled “Reviews”:
  • “I was desperate last month after having an I 131 treatment for Graves Disease. I was fatigued to the point of being unable to work. I was not eating due to nausea. I have only been taking the supplement for about a month and although my medical status has improved I do believe that the SuperFood has been a great help to me…”
  • “[H]ELPS WITH DIABETES…”
  • “I have crohn’s disease…So this product...has helped my crohn’s symptoms…”
  • “My allergies are less severe after being outdoors…”
  • “Reduced some of my joint pains and dependency on medications…”
 
“Grab-N-Go Daily”:
On the webpage titled “Reviews”:
  • “[H]aving inflammation problems and I’ve been on a series of antibiotics…”
 
Your website, www.texassuperfood.com, also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
SuperFood Single Powder”:
On the webpage titled “Reviews”:
  • WANT TO GET RID OF MY TYPE 2 DIABETES…Due to have my diabetes checked this week. Hope Texas Super Foods is working for me. Don’t want to have to take prescription meds. for it…”
  • “DIAGNOSED WITH SCOLIOSIS, BREAST and BONE CANCER…complete the nutrition needed to help the body heal…”
  • “DIAGNOSED WITH LYMPHOMA LAST YEAR…we just “feel” better!...”
  • “AM EXCITED TO SEE THE EFFECTS…no diabetes medication…”
  • “Help my chronic fatigue…”
  • “[C]ame home with a terrible stomach infection…”
  • “[T]akes a lot of blood pressure meds. These have side effects …”
 
SuperFood Single”:
On the webpage titled “Reviews”:
  • “[H]elping my gout problems…”
  • “[I]s diabetic and gets headaches all the time. We thought it was from food with gluten in it. She’s been taking Superfood for 5 months now and she doesn’t get headaches, even when she eats food with gluten…”
  • “[M]y chronic reflux seems to have subsided…”
Grab-N-Go Daily”:
On the webpage titled “Reviews”:
  • “[H]aving inflammation problems and I’ve been on a series of antibiotics…”
 
SuperFood Double”:
On the webpage titled “Reviews”:
  • “I AM A DIABETIC. I WAS HOPING TO LOWER MY SUGAR LEVEL AND STAY OFF OF INJECTIONS…”
  • “[A]fter just 3 months…my cholesterol was down 30 points to 157…”
  • “[A]rthrtis (sic) in my fingers on my right hand from work related activity. i have noticed that when i am taking the super food on a regular basis the pain and the swelling seems to subside…”
  • “[H]as cancer and he is taking superfood. He has felt great with no side effects on Chemo other than hair loss…”
  • “[H]elping my gout problems…”
  • “[T]hat the psoriasis on my legs…”
  • “[N]ote I was hoping to control my diabetes with the increased 12 servings of fruits and vegetables…”
  • “[M]y acid reflux has improved…”
  • “[H]elp our daughter’s diet and nutrition balance as she fights Lyme Disease…”
  • “[H]oping I can also eventually get off my thyroid medication and B-12 shots…”
  • “[A]m on warfarin…”
  • “[R]educe my dependence on diabetes drugs…”
  • “HAVE STOPPED TAKING MEDICATION FOR GOUT…”
 
SuperFood Family Powder”:
On the webpage titled “Reviews”:
  • "H]ad migraine headaches…”
  • “Waiting for the cold and flu season…”
  • “[L]ower blood pressure…”
  • “Helps my wife…with the fatigue that accompanies RA…”
  • “[H]elps diabetes…”
  • “[L]owered by blood pressure…”
  • “[L]ower BP…”
 
SuperFood Family”:
On the webpage titled “Reviews”:
  • “[G]et my body in balance, so I no longer get migraines…”
  • “[D]epend on thyroid hormone replacement medication and suffer from side effects common to hypothyroidism…”
  • “[T]hirteen year old son with severe autism…”
  • “HOPING TEXAS SUPER FOOD WOULD HELP LOWER MY BLOOD PRESSURE…”
 
Your 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Cleansing Combo Pak,” “Supersilver Solution,” “Royal Tea,” “Omega Oil 3•6•9,” “Probio Boost,” “ParaMax Cleanse,” and “Heavy MetalMax” 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, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their 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)]. It is also a violation of section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a drug that causes the drug to become misbranded while it is held for sale after the shipment of one or more of its components in interstate commerce.
 
Adulterated Dietary Supplements
 
Even if your “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Cleansing Combo Pak,” “Supersilver Solution,” “Royal Tea,” “Omega Oil 3•6•9,” “Probio Boost,” “CleanseMax,” “ParaMax Cleanse,” and “Heavy MetalMax” products did not have therapeutic claims which make them unapproved new drugs, these products and all dietary supplement products that you manufacture would still be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements. 
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. The Act also prohibits a person from doing any act with respect to a dietary supplement, if such act is done while the dietary supplement is held for sale after shipment in interstate commerce and results in the dietary supplement being adulterated [see 21 U.S.C § 331(k)]. Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.  Further, you conduct final manufacturing in the form or packaging and labeling of your Grab-N-Go Daily and Royal Tea products which, in addition to the above, also obligates you for the development and documentation of records related to those manufacturing steps.
 
During our inspection, our investigators observed the following significant violations, which were noted on Form FDA 483, Inspectional Observations, issued to you on March 6, 2014. We received your written responses dated March 24, 2014, June 6, 2014, and July 7, 2014 to the Form FDA 483. Review of your responses and related documentation revealed that your firm has not made adequate corrections, as further described below.  
 
1.    You failed to establish specifications for identity, purity, strength, composition, and limits on contaminants for each component used in the manufacture of your dietary supplements, as required by 21 CFR 111.70(b). During the inspection you stated that you had no established specifications; in addition, you were unable to determine if your contract manufacturers had established specifications for your manufactured dietary supplement products.
 
Additionally, you were unable to provide records of established specifications for the ”Royal Tea” product that you receive from your contract manufacturer and further process into tea bags, and then package and label as required by 21 CFR 111.95(b)(1).
 
We have reviewed your response dated July 7, 2014 and find it to be inadequate. You have provided only a listing of the identity or name of the components for your products, which is not the same as a specification ensuring the identity, purity, strength or composition of the component.
 
2.    You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).  Specifically, during the inspection, you acknowledged that you have not developed specifications for any of your ten brand name dietary supplement products, or the components which are used to manufacture these products.
 
We have reviewed your response dated July 7, 2014. You have provided Certificates of Analysis (COAs) for various dietary ingredients, which you have obtained from your contract manufacturers and suppliers. However, in order to rely on a COA from the supplier of a component, you must first qualify the supplier by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s tests or examinations in accordance with 21 CFR 111.75(a)(2)(ii)(A). In your response, you stated that you have contacted each of your manufacturers and suppliers, and “have qualified each entity through a formalized protocol . . . .” Because you did not submit such a protocol or other documentation to demonstrate that you have qualified your suppliers, we are unable to evaluate the adequacy of your response.
 
3.    You failed to establish specifications for the packaging and labeling of the finished dietary supplements, as required by 21 CFR 111.70(g). During the inspection you stated that you had no established specifications for the packaging and labeling of your finished dietary supplements. 
 
Your written responses, dated March 24, 2014, June 6, 2014 and July 7, 2014, appear to reference the standard operating procedure manual which you provided in your March 24, 2014 response. However, this manual does not discuss packaging and labeling specifications. Further, the documents you provided and described as master manufacturing records (MMRs) for your “Grab-N-Go” and “Royal Tea” products do not reflect the manufacture of these products within your establishment. 
 
You failed to prepare and follow a written MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 11.205(a). Specifically, at your facility, you perform the final packaging and labeling for the “Grab-N-Go” and “Royal Tea” products; however, you do not maintain any records related to these activities to ensure that the products are uniform from batch to batch.  In addition, you failed to ensure that dietary supplements are packaged and labeled as specified in the MMR, as required by 21 CFR 111.205(b)(1).
 
We have reviewed your responses dated March 24, 2014, June 6, 2014, and July 7, 2014 and determined your response is inadequate. Although you have generated procedures for your packaging and labeling operations, these procedures are not MMRs.
 
4.    You failed to establish a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55.
 
We have reviewed your responses dated March 24, 2014, June 6, 2014, and July 7, 2014. Your response states you have contacted each of your suppliers and have qualified them through a formal protocol, which includes evaluating the adequacy of the supplier’s COA. However, you did not provide this established protocol or data demonstrating you have verified the supplier’s COA. Further, your response states you have on-site staff reviewing the records provided by your suppliers that show their processes; however, your response does not include information to describe how you will document this review and approval. Because you have not provided any documentation, we are unable to evaluate the adequacy of your response.
 
5.    You were not able to provide documentation which determined the complete manufacturing history and control of your packaged and labeled dietary supplement through distribution, as required by 21 CFR 111.410(d). Specifically, you do not assign a batch, lot, or control number to each lot of your “Grab-N-Go” and “Royal Tea” products that you label and/or package for distribution as required by 21 CFR 11.415(f)(1).
 
Misbranded Dietary Supplements
 
Even if your “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Supersilver Solution,” ‘Royal Tea,” “Omega Oil 3•6•9,” and “Probio Boost” products were not unapproved new drugs, they would still be misbranded under section 403 of the Act [21 U.S.C. § 343], in that the labeling for these products does not comply with the labeling requirements for dietary supplements and other foods, as follows:
 
1.    Your “Probio Boost,” “Omega Oil 3.6.9,” “Superfood Single,” ”Superfood Single Powder,” “Superfood Double Capsules,” “Superfood Family Capsules,” “Superfood Family Powder “Grab-N-Go,” “Supersilver Solution,” and “Royal Tea” products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
2.    Your “Probio Boost,” “Omega 3.6.9,” and “Royal Tea” products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information does not comply with 21 CFR 101.36. Specifically:
  • Your “Royal Tea” product label does not contain a supplement facts panel. While the label does contain the heading “Supplement Facts” and a listing of a proprietary blend of ingredients, the requirements of 21 CFR 101.36 are not met. For example, there is no serving size declaration [21 CFR 101.36(b)(1)], the quantitative amount of the proprietary blend is not listed [21 CFR 101.36(c)(3)], the nutrition information is not enclosed in a box and it does not meet other general formatting requirements [21 CFR 101.36(e)];
  • Your “Omega 3.6.9” product does not include the “Servings Per Container” information, as required by 21 CFR 101.36(b)(1)(ii);
  • The “enzyme blend” on your “Probio Boost” product label does not include the quantitative amount by weight of the blend, as required by 21 CFR 101.36(c)(3); and
  • The nutrition information on your “Probio Boost” product label is not enclosed in a box, as required by 21 CFR 101.36(e)(2).
 
3.     Your “Probio Boost,” “Omega Oil 3.6.9,” “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules, “Superfood Family Powder,” and “Royal Tea” products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1) because the labels do not contain the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
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 ensure 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/or injunction.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
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 violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.    
 
Please submit your response to Jeff R. Wooley, Compliance Officer, at the above letterhead address. If you have any questions please contact Jeff R. Wooley, Compliance Officer, Dallas District Office at 214-253-5251.
 
Sincerely,
/S/                                                                            
Reynaldo R. Rodriguez, Jr.
Dallas District Director 
 
 
CC: 
Mr. Greg Wilburn
Inspection Unit Manager
Food and Drugs Inspection Branch
Texas DSHS
1100 West 49th Street
Austin, Texas 78756

 

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