WARNING LETTER

Hekma Center, LLC MARCS-CMS 637652 — June 02, 2023

Delivery Method:: United Parcel Service
Product:: Dietary Supplements

Recipient:: Recipient Name

Mr. Younis; Hekma Center, LLC; 24A Trolley Square #2131
Wilmington, DE 19806
United States

Issuing Office:: Center for Food Safety and Applied Nutrition (CFSAN); United States

June 2, 2023

RE: CMS # 637652

Dear Mr. Younis:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.hekmac.com in February 2023 and has determined that you take orders there for your Natural Supplements for Anemia, Lymf (Galium aparine), Natural Supplements for Cardiomyopathy, Magic1 (Moringa oleifera), Natural Supplements for Diabetes Mellitus, Cinna (Cinnamomum Zeylanicum), Natural Supplements for High Blood Pressure – Hypertension, kraph (Apium graveolens), Natural Supplements for Stroke – CVA, Cam1 (Silybum marianum), Danshen (Red sage), Multiple Sclerosis Package, and Smile Package products.

We also reviewed your social media websites, https://www.facebook.com/hekmac.supplement, https://www.instagram.com/hekma.c, https://twitter.com/hekma_center, and https://www.youtube.com/channel/UC_eIcBlLWbVkaj96gurUDdw, each of which directs consumers to your website, https://www.hekmac.com, to purchase your products. The claims on your website and social media websites establish that your 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 diseases. 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.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include the following:

Natural Supplements for Anemia

On your “Natural Supplements for Anemia” product page at https://www.hekmac.com/en.shop2/supplements-for-anemia:
 “Supplement package for Anemia – Iron Deficiency”
 “All products are safe for use and are very potent in helping people with Anemia.”
 “Indicated for: People with Anemia”
 “Many scientific studies have proven the medicinal properties and the efficiency of these herbs in helping with Anemia naturally without causing any side effects.”
 “Patients with acute anemia should add royal sidr product (sidr honey with royal jelly) [an ingredient in your Multiple Sclerosis Package] to the package above.”

Lymf (Galium aparine)

On your “Cleavers-Goosegrass” product page (which you also describe as your “Lymf Product”) at https://www.hekmac.com/en/shop2/cleavers-goosegrass:

“Lymf product – Cleavers is indicated for:
…
2. Edema and fluid retention in the abdomen
3. A large scale of skin diseases and inflammations such as psoriasis, eczema….
4. Detoxification because it purifies the body from accumulated toxins.
5. Urinary system diseases such as urine detention, kidney and bladder stones, overactive bladder (OAB), urinary tract infections and prostatitis.
…
7. Gout and rheumatism, as well as osteoarthritis which is the most common bone disease.
8. Cystic mastopathy.
9. Interstitial Lung Disease.
10. Gastritis and duodenitis, as well as for gastric ulcer
11. . . . hepatohemia and liver cyst.
12. Patients with acute anemia.
13. Constipation . . .
14. Swelling of the Vocal cords.
15. High blood pressure – Hypertension.
16. Some cases of kidney failure . . .
17. Thyroid gland disorders.”

Natural Supplements for Cardiomyopathy

On your “Natural Supplements for Cardiomyopathy” product page at https://www.hekmac.com/en.shop2/supplements-for-cardiomyopathy:

• “Supplement package for Cardiomyopathy – Heart Muscle Weakness”
• “All products are safe for use and are very potent in helping people with Cardiomyopathy – Heart Muscle Weakness.”
• “Indicated for: People with Cardiomyopathy”
• “Many scientific studies have proven the medicinal properties and the efficiency of these herbs in helping with Cardiomyopathy naturally without causing any side effects.”
• “Patients who have edema – fluid retention, should also add 1 bottle of . . . Lymf product (Gallium aparine), Kraph product (Apium Graveolens).”

Magic1 (Moringa oleifera)

On your “Moringa Oleifera leaves” product page (which you also describe as your “Magic1 Product”) at https://www.hekmac.com/en/shop2/moringa-oleifera/:

“Magic1 product - Moringa Oleifera is indicated:
1. for Osteoporosis. It is a very important dietary supplement for women above the age of 45. Moringa may help in bone healing process after a fracture because it is rich in easily absorbed calcium…
3. as a dietary supplement to strengthen the immune system against diseases . . .
4. for Arthritis and joint pain.
5. to balance blood sugar level and effectively improve Diabetes type 2.
6. for Anemia because it is very rich in iron and vitamin B12.
7. to balance cholesterol and triglycerides level in the blood.
8. for Gout.
…
10. . . . heart diseases such as atherosclerosis, weak heart muscle, and thrombosis . . .
11. to reduce high blood pressure.
12. for hair loss . . .”

“Additional Indications:
1. May help with kidney stones and effectively improves liver infections and liver cirrhosis . . .
2. for parasites, fungi and worms in the digestive system and the intestines.
3. for ulcerative colitis, for small intestine inflammation and for Crohn's disease. It is also indicated for stomach and duodenum ulcer, Helicobacter and digestive system disorders.
4. for asthma and allergies of the respiratory system.
5. To balance thyroid gland functioning especially in case of Hypothyroidism . . .
6. . . . It also alleviates blood clotting and regulates heartbeat
. . .
10. . . . eliminate dementia and Alzheimer's disease.
11. for Systemic Lupus Erythematous (SLE).
12. for migraine.”

“More Indications
. . .
5. for Multiple sclerosis (MS). It limits disease progression.
6. to protect brain cells from a stroke. Prefer to take it after a stroke to reduce its effects.
7. for brain diseases . . . and Parkinson’s disease.
. . .
9. may help overcome acute hepatitis B.
. . .
12. for herpes and genital herpes.”

Natural Supplements for Diabetes Mellitus

On your “Natural Supplements for Diabetes Mellitus” product page at https://www.hekmac.com/en.shop2/supplements-for-diabetes:

• “Supplement Package for Diabetes Mellitus - Type 2”
• “All products are safe for use and are very potent in helping people with Diabetes mellitus.”
• “Indicated for: People with Diabetes Mellitus”
• “Many scientific studies have proven the medicinal properties and the efficiency of these herbs in helping with Diabetes mellitus naturally without causing any side effects.”
• “If the patient has hypertension or other cardiovascular disease, we recommend to add 1 . . . …1 bottle of Danshen product (salvia miltiorrhiza) to the package above.”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Natural Supplements for Diabetes Mellitus for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your webpage titled, “Overcoming Diabetes Completely is Possible! Read the Story of Mr. Murtada from KSA” accessible at https://www.hekmac.com/en/overcoming-diabetes-completely/:

• “33-year-old Mr. Murtada from KSA is one of many cases that overcame diabetes type 2.
He contacted our team . . . describing his health condition and informing us that he takes ‘Omformin’ (a medication for reducing high blood sugar levels). Hekma Center's team inquired about his condition and his prescribed medications. In turn, Mr. Murtada provided them all the information, and the team prepared a suitable wellness package. . . . Mr. Murtada delivered wonderful news, he reduced the Omformin dose to one per day after he used to take 4 and a half! Mr. Murtada said, ‘I loved the supplements you provide.’ The organic, herbal supplement from Hekma Center contributed to reducing the prescribed diabetes medication dose, which confirms that he is on the right path to overcoming diabetes completely. . . Mr. Murtada sent his newest test results . . . The CBC test generally reveals several diseases, including diabetes, by measuring the blood sugar levels from the blood sample. Moreover, it helps to know the glucose levels in the blood and avoid getting diabetes mellitus. Mr. Murtada did this test, and the results showed that the diabetes test came out normal in the fasting and accumulated blood sugar tests. We congratulate Mr. Murtada on overcoming diabetes entirely as if it never existed. We are delighted with these incredible results.”

Cinna (Cinnamon zeylanicum)

On your “Cinnamon – Cinnamomum Zeylanicum” product page (which you also describe as your “Cinna Product”) at https://www.hekmac.com/en/shop2/cinnamon/:

“Cinna product - Cinnamon indications:
1. Cinnamon . . . may help remove bile salts, thus may help with any damage that may occur to colon cells and reduces the risk of having various colon diseases.
2. to balance blood sugar level . . . 3-6 grams of cinnamon a day reduces blood sugar level 29%, which very much may help patients with diabetes type 2.
3. to reduce cholesterol level. The fibers and calcium in cinnamon eliminate bile salt from the body. When bile salt is eliminated, the body breaks down cholesterol in order to produce a new bile. This process may help reduce high cholesterol level. According to a study conducted in 2003, 1 teaspoon a day (1 gram) of cinnamon significantly reduce LDL (bad cholesterol) and triglycerides.
4. to improve blood circulation since it contains a large amount of coumarin, which may help with blood clotting that may cause heart disease . . .
5. for arthritis because it has anti-inflammatory properties . . . It also may help with muscle dystrophy.”

“Additional Indications
1. Candida infection and various fungal diseases because it is anti-fungal.
2. . . . It also used for chronic diarrhea, irritable bowel syndrome (IBS) and constipation.
3. Cinnamon supports the respiratory system diseases and disorders such as, severe cold, cough, chronic cough, flu, sore throat, pulmonary fibrosis, phlegm, mucus and inflamed tonsils.
4. for menstrual cycle pain, postpartum uterus pain and contractions, as well as hypomenorrhea.
. . .
6. . . . chronic fatigue.
7. for high blood pressure.
8. for urinary tract infections, vaginal secretions in addition to inflammations in the reproductive system . . .
9. . . . It may help with memory loss and dementia.
10. . . . it is a great supplement in cases of high fever.
. . .
12. for muscle atrophy . . .
13. for multiple sclerosis.
14. for a headache caused by cold air, migraine and pain in general.

Natural Supplements for High Blood Pressure – Hypertension

On your “Natural Supplements for High Blood Pressure - Hypertension” product page at https://www.hekmac.com/en.shop2/supplements-high-blood-pressure:

• “Supplement package for High Blood Pressure - Hypertension”
• “All products are safe for use and are very potent in helping people with High Blood Pressure.”
• “Indication for: People with High Blood Pressure - Hypertension”
• “Many scientific studies have proven the medicinal properties and the efficiency of these herbs in helping with High Blood Pressure naturally without causing any side effects.”

kraph (Apium graveolens)

On your “Celery Seed – Apium Graveolens” product page (which you also describe as your “kraph product”) at https://www.hekmac.com/en/shop2/celery-seed-apium-graveolens:

“kraph product - Celery seed is indicated for:
1. Acute urinary tract inflammations, urinary tract stones, and kidney diseases . . .
2. Ascites (an accumulation of fluid in the limbs and abdomen) and as a diuretic.
3. Rheumatoid arthritis in addition to rheumatoid pain and muscle aches.
4. Gout.
5. Hypertension …because it reduce high blood pressure.
6. To relieve cough and reduce phlegm.
. . .
8. Some brain diseases like dementia, Alzheimer's, multiple scleroses [sic] (MS) and also cerebritis.
. . .
11. Jaundice . . .
12. Anorexia . . .
13. To reduce LDL cholesterol (bad cholesterol).
14. As a tranquilizer to reduce stress . . .
15. Insomnia . . .
16. Impotence . . .
. . .
18. . . . anti-inflammatory.
19. Also for Sciatica.”

Natural Supplements for Stroke - CVA

On your “Natural Supplements for Stroke - CVA” product page at https://www.hekmac.com/en.shop2/supplements-for-stroke-cva/:

• “Supplement package for Stroke – CVA [cerebral vascular accident]”
• “All products are safe for use and are very potent in helping people with stroke.”
• “Indicated for: People with Stroke - CVA”
• “Many scientific studies have proven the medicinal properties and the efficiency of these herbs in helping with Stroke naturally without causing any side effects.”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Natural Supplements for Stroke – CVA for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your webpage titled, “After One Week of Taking the Stroke Herbal Supplements; Mr. Ali from Oman Started Improving!” at https://www.hekmac.com/en/mr-ali-started-improving/:

• “76-year-old Mr. Ali had a stroke when he was 74 years old, and it led to many complications, and his condition severely deteriorated. He was not able to walk, speak, drink water, and swallow properly. As well as problems and difficulty breathing, constant phlegm, and a bad mental state. Not to mention that he suffered for a long time from diabetes and high blood pressure. . . Mr. Ali's son . . . contacted Hekma Center's team through email to inquire about a relief method for his father. Doctor Sarah replied to him and helped him order the wellness supplement package for strokes . . . After only one week of taking the supplements for strokes’ [Mr. Ali’s son] contacted the personal doctor from Hekma . . . and informed her that his father's condition significantly improved! [He] pointed out that the stroke complications noticeably decreased; wherein he is more energetic, in a great mental state, has no breathing difficulties, and phlegm greatly decreased.”

Cam1 (Silybum marianum)

On your “Milk Thistle – Silybum Marianum” product page (which you also describe as your “Cam1 product”) at https://www.hekmac.com/en/shop2/milk-thistle/:

“Cam1 product - Milk thistle is indicated for:

1. Different liver diseases and liver infections . . . It is scientifically proven that it can alleviate Hepatitis C and B, and in most cases even heal it completely, if taken for a period of two consecutive months.
2. Liver cleansing from alcohol toxins, drugs toxins, and virus toxins.
3. Fatty liver, Hepatic fibrosis, liver cirrhosis and for liver dysfunction . . .
4. Chronic Hepatitis and Alcoholic Hepatitis.
5. Crohn's disease, Ulcerative colitis, and gastroenteritis.
6. . . . chronic diarrhea, vomiting, nausea and others, and for renal infection and renal toxicity.
7. May help with dyspepsia . . .
. . .
11. . . . dyspepsia especially in children, and may to help with food allergy in an early age . . .”
12. Hypercholesteremia and Hypertriglyceridemia
. . .
14. Allergies”

“Additional Uses
1. Internal and external hemorrhoids.
2. Different skin problems like . . .psoriasis.
. . .
4. Some cases of migraine.
5. Hypotension. Which is a rare feature for medicinal herbs.
. . .
8. Milk Thistle [an ingredient in your Cam1 product] reduces cholesterol- LDL level and may help with its oxidation and deposit in arteries walls, a thing that might cause a heart attack.”
9. May help with the formation of gallstones . . .
10. To effectively reduce high fever.
11. Parkinson's disease.
. . .
13. In combination with drugs that may cause damage to the liver, in order to protect the liver from liver damage.
14. To reduce insulin intake especially in diabetes patients and hepatic fibrosis patients.
15. Severe constipation.
16. Varicosis.
17. Uterine congestion and uterus infection.”

Danshen (red sage)

On your “Red Sage – Dan shen” product page at https://www.hekmac.com/en/shop2/red-sage-dan-shen:

• “It [Red sage, an ingredient in your Danshen product] supports various heart diseases, chest pain and tightness in the chest, palpitation . . . sleep disorders, menstruation disorders, stomachache”
• “Red sage increases blood flow in different ways: by reducing blood clots\ thromboses . . . and by reducing cholesterol level.”
• “Dan Shen Product – Red Sage is [sic] Indications:
1. Angina pectoris, Myocardial infarction and heart failure . . .
2. Cardiovascular diseases . . . atherogenesis, Arrhythmia, and hypertrophy . . .
3. Hypertriglyceridemia.
4. Hypertension and poor Peripheral blood flow, as well as, promotes hypercoagulability of the blood.
5. Viral hepatitis, liver fibrosis, cirrhosis, cystic liver . . . fatty liver. . . .
6. Multiple sclerosis (MS).
7. Pancreatitis and gallbladder infections.
8. Digestive system disorders such as difficulty digesting fats (Dyspepsia), irritable bowel syndrome (IBS), ulcerative colitis, Crohn's disease . . .”
9. Menstruation disorders . . . amenorrhea, infertility and irregular uterine bleeding.”

• “Additional Indications
. . .
2. Anemia especially after excessive bleeding.
3. Osteoporosis, Avascular necrosis and Osteonecrosis . . .
4. Impotency and infertility in men . . .
. . .
6. May help protect and support people with Diabetes type 2 and type 1.
7. Mental-emotional disorders . . . mental exhaustion, sleeping disorders, palpitation . . . and even depression.
8. Chronic skin diseases in children and adults and for allergies especially if they are related to liver dysfunction or digestive system dysfunction.
9. Stomach and duodenal ulcers and for intractable wounds.
10. It protects against Alzheimer [sic] and dementia in the elderly.
11. Arthritis. . .
12. . . . It strengthens the immune system especially for people that suffer from recurrent infections and viral diseases.
13. Supports chronic bronchitis.
. . .
15. Anaphylaxis.
16. As an anti-microbial . . .
17. Also to improve kidney function after a kidney transplant.”

On your Youtube video titled, “Benefits of Organic red sage – Dan shen capsules” at https://www.youtube.com/watch?v=XAgF_mmwBes, which includes links in the video description where the product can be purchased on https://www.hekmac.com:

In the video description:
• “Dan shen . . . treats various heart diseases, chest pain and tightness in the chest, palpitation . . . sleep disorders, menstruation disorders, stomachache and more.”

Text in the video:
• “It is mostly used to . . . treat various heart diseases” (0:32)
• “also used to treat: chest pain . . . sleep disorders, menstruation disorders and stomachache.” (0:39)
• “Research conducted on Red sage [an ingredient in your Dan shen product] indicated that it has [the] same effect as Nitroglycerin a drug used to expand blood vessels” (0:57)
• “it helps treat diseases like Avascular necrosis and Osteonecrosis” (1:18)
• “It increases blood flow by: reducing blood clots . . . by reducing cholesterol” (1:49)
• “Dan Shen product is indicated for: Digestive disorders . . .” (2:06)

Multiple Sclerosis Package

On your Facebook page at https://www.facebook.com/hekmac.supplement:

• In a November 9, 2021 post titled, “The Journey of Jy in Winning Over MS – Multiple Sclerosis Disease – Hekma Center” which links to your website where the “Multiple Sclerosis Package” is offered for sale with the following claims:
o “Clinical signs, symptoms, physical and mental status were improved in an MS patient after a short period of using Hekma Center natural supplements”
o “Contains the natural supplements that will help you overcome and get rid of this disease.”

Smile Package

On your “Smile Package” product page at https://www.hekmac.com/en/shop2/smile-package:
• “High-quality natural products to relieve depression, nervousness, tension, anxiety, panic, fatigue, exhaustion . . .”
• “Indicated for: People with Depression”

On your Instagram page at https://www.instagram.com/hekma.c and on your Twitter page at https://twitter.com/hekma_center you link to your “Smile Package” product page with the hashtags “#smile_pakage [sic] . . . #Depression.”

Your Natural Supplements for Anemia, Lymf (Galium aparine), Natural Supplements for Cardiomyopathy, Magic1 (Moringa oleifera), Natural Supplements for Diabetes Mellitus, Cinna (Cinnamomum Zeylanicum), Natural Supplements for High Blood Pressure – Hypertension, kraph (Apium graveolens), Natural Supplements for Stroke – CVA, Cam1 (Silybum marianum), Danshen (Red sage), Multiple Sclerosis Package, and Smile Package products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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.

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 products Lymf (Galium aparine), Natural Supplements for Cardiomyopathy, Magic1 (Moringa oleifera), Natural Supplements for Diabetes Mellitus, Cinna (Cinnamomum Zeylanicum), Natural Supplements for High Blood Pressure – Hypertension, kraph (Apium graveolens), Natural Supplements for Stroke – CVA, Cam1 (Silybum marianum), Danshen (Red sage), Multiple Sclerosis Package, and Smile Package 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, Lymf (Galium aparine), Natural Supplements for Cardiomyopathy, Magic1 (Moringa oleifera), Natural Supplements for Diabetes Mellitus, Cinna (Cinnamomum Zeylanicum), Natural Supplements for High Blood Pressure – Hypertension, kraph (Apium graveolens), Natural Supplements for Stroke – CVA, Cam1 (Silybum marianum), Danshen (Red sage), Multiple Sclerosis Package, and Smile Package 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

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 these matters may result in legal action including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 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 reply should be directed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.

Sincerely,
/S/

Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration