WARNING LETTER
Great Healthworks, Inc.
MARCS-CMS 611686 —
June 23, 2021
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ken Meares
Recipient Title
Chief Executive Officer
Great Healthworks, Inc.
4150 SW 28th Way
Fort Lauderdale
,
FL
33312-5201
United States
Issuing Office:
Office of Human and Animal Food Operations, Division IV East
United States
WARNING LETTER
June 23, 2021
21-HAFE4-WL-06/CMS No. 611686
Dear Mr. Meares:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.greathealthworks.com/ in May 2021 and has determined that you take orders there for the products ProbioticXL and OmegaXL. The claims on your website 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. Further, even if your ProbitoticXL were not an unapproved new drug, it would be a misbranded food under section 403 of the Act [21 U.S.C. 343]. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Unapproved New Drugs
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
ProbioticXL
On the webpage https://probioticxl.com
• “Combats bad bacteria”
• “ ClearPhage® [an ingredient in PriobioticXL] is a natural patented ingredient that targets harmful bacteria . . ..”
On your website page: https://probioticxl.com/probiotics-and-your-health/
• “ProbioticXL® reduces harmful bacteria with its prebiotic – ClearPhage™.”
• “ProbioticXL® . . . inhibits yeast growth with its Protective Shield Technology.”
On your website page https://probioticxl.com/why-probioticxl/
• “Reduces harmful bacteria with its prebiotic – ClearPhage™”
• “Protective Shield Technology – . . . reduces potentially harmful bacteria. Inhibits yeast growth . . .”
• “ClearPhage™ [an ingredient in ProbioticXL®] – Reduces harmful bacteria”
• “Reduce abdominal pain . . .”
• “Reduce the risk factors of cardiovascular disease, especially in smokers”
• “Calm skin irritation”
• “Protect the intestinal barrier against damage . . .”
• “Sustain normal levels of intestinal bacteria post-antibiotic treatment”
• “Alleviate inflammation in the large intestine”
• “Reduce cardiovascular disease risk factors . . .”
• “[C]learPhage™ is a natural patent pending ingredient that inhibits the growth of harmful bacteria . . ..”
On your webpage https://probioticxl.com/the-science-behind-probioticxl/
• “Reduce harmful bacteria in the intestine”
• “Inhibit yeast growth”
• “Lactobacillus Acidophilus [an ingredient in ProbioticXL®] = Reduces abdominal pain”
• “Lactobacillus Plantarum [an ingredient in ProbioticXL®] = Reduces the risk factors of cardiovascular disease, especially in smokers”
• “Lactobacillus Rhamnosus [an ingredient in ProbioticXL®] = Calms skin irritation”
• “Lactobacillus Salivarius [an ingredient in ProbioticXL®] = Protects the intestinal barrier against damage”
• “Lactobacillus Brevis[an ingredient in ProbioticXL®] = Improves inflamed gum conditions”
• “Bifidobacterium Lactis [an ingredient in ProbioticXL®] = Sustains normal levels of intestinal bacteria post antibiotic treatment”
• “Bifidobacterium Bifidum [an ingredient in ProbioticXL®] = Alleviates inflammation in the large intestine”
• “Streptococcus Thermophilus [an ingredient in ProbioticXL®] = Reduces cardiovascular disease risk factors . . .”
OmegaXL
On your webpage: https://www.greathealthworks.com/
• “[S]hown to help relieve joint pain due to inflammation”
• “OmegaXL is widely recognized as a leader in natural relief from pain due to inflammation.”
On the webpage: https://www.omegaxl.com/
• “In a study of 50 participants, the group taking the active ingredient in Omega XL, the lipid extract from the New Zealand Green-Lipped Mussel, showed an 89% improvement in joint discomfort due to inflammation.”
OmegaXL order form page:
• “Helps reduce joint pain due to inflammation”
On your product page under OmegaXL Blog: Blog post “What Makes OmegaXL So Effective? PCSO-524” dated May 15, 2014:
• “(PCSO-524), found in OmegaXL, has demonstrated to be an effective complementary or alternative course of action for providing relief from joint pain, as well as other inflammatory conditions . . . OmegaXL gel caps have been sold to satisfied customers who enthusiastically confirm the incredible inflammation fighting and long term joint pain managing effect they experienced with this unique, all-natural product.”
On your product page under “Joint Discomfort”:
• “[O]MEGAXL HELPS RELIEVE JOINT DISCOMFORT ON MANY LEVELS . . . Joint discomfort due to inflammation hurts . . .”
• “OmegaXL is shown in clinical research to help relieve joint discomfort due to inflammation.”
On your product page under “Why OmegaXL”:
• “[D]emonstrated in over 30 years of clinical research to help relieve joint discomfort due to inflammation . . .”
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)]. With certain exceptions not applicable here, 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 and information demonstrating that the drug is safe and effective.
Misbranded Food
Even if your ProbioticXL product was not an unapproved new drug, it would be a misbranded food within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C.343(r)(1)(B)] in that the product labeling bears the following unauthorized health claims:
• On your website https://probioticxl.com/why-probioticxl/:
o “Reduce the risk factors of cardiovascular disease, especially in smokers”
o “Reduce cardiovascular disease risk factors together with Lactobacillus Rhamnosus and Lactobacillus Acidophilus”
• On your website https://probioticxl.com/the-science-behind-probioticxl/:
o “Lactobacillus Plantarum [an ingredient in ProbioticXL®] = Reduces the risk factors of cardiovascular disease, especially in smokers”
o “Streptococcus Thermophilus [an ingredient in ProbioticXL®] = Reduces cardiovascular disease risk factors together with Lactobacillus Rhamnosus and Lactobacillus Acidophilus.”
These health claims misbrand your product because they have not been authorized either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]]. We also note that FDA has not issued a Letter of Enforcement Discretion for such claims.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to the Food and Drug Administration, Attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Beira Montalvo, Compliance Officer, at (561) 416-1065 ext. 1108 or via e-mail at Beira.Montalvo@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food Operations,
Division IV East
Content current as of:
06/29/2021
Regulated Product(s)
Food & Beverages