On June 2, 2023, the FDA issued a warning letter to Hekma Center, LLC following review of the company’s website and social media, which found statements about the company’s 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 to be drug claims, which are not permitted for dietary supplements.

For example, Natural Supplements for Anemia were promoted with statements such as, “All products are safe for use and are very potent in helping people with Anemia.” and “Many scientific studies have proven the medicinal properties and the efficiency of these herbs in helping with Anemia naturally without causing any side effects.”

For more information about related products, see ConsumerLab’s answer to Which supplements can help treat anemia? Do any supplements cause a low red blood cell count?

Magic1 (Moringa oleifera) products were promoted with statements such as, “…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…” and “May help with kidney stones and effectively improves liver infections and liver cirrhosis . . .”

For more information about related products, see ConsumerLab’s answer to Do any supplements or diets help prevent or treat osteoporosis? and Which supplements and foods reduce or increase the risk of kidney stones?

Natural Supplements for Diabetes Mellitus were promoted with statements such as, “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.”

For more information about related products, see ConsumerLab’s answer to Which supplements and foods can help lower or control blood sugar?

Cinnamon (Cinnamon zeylanicum) products were promoted with statements such as, “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.” and “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.”

For more information about related products, see ConsumerLab’s Cinnamon Supplements and Spices Review.

Also see: Which supplements or foods can help lower cholesterol and keep my heart healthy? Are there any to avoid?

Cam1 (Silybum marianum) products were promoted with statements such as, “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.”

For more information about related products, see ConsumerLab’s Milk Thistle Supplements Review.

Smile Package products were promoted with statements such as, “High-quality natural products to relieve depression, nervousness, tension, anxiety, panic, fatigue, exhaustion . . .”

For more information about related products, see ConsumerLab’s answer to What are the best supplements for depression and anxiety?

Also see: Which supplements help to improve energy and decrease fatigue?

Additionally, the FDA stated in its letter that it considers these products to be “new drugs” because products are not recognized as safe and effective for their intended use. The FDA also found products to be misbranded because product labeling failed to bear adequate directions for their intended uses.

Hekma Center, LLC must respond to the agency within 15 days of receipt of the warning explaining the specific steps taken to address any violations.

For more information, use the link below.

Warning: Hekma Center, LLC

See related recalls and warnings:

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