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Warning to D-Limonene, Vitamin C Seller

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If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem.
(Date Posted: 2/10/2018)

On January 31, 2018 the FDA issued a warning letter to Long Life Unlimited, LLC following a review of the company's website which found promotional statements and testimonials made about products including Balance 600, D-Limonene, Rapha Remedy, Rapha Remedy w/ p73 Wild Oregano, Vitamin C, Buffered TR, Multi Forte Plus, Natural Beta Carotene, Natural Vitamin E, Omnizyme, Thymus, Selenium Chelate, Super 15, and Super B-10 to be drug claims.

(See Pinoypharmacy.com's Reviews of Vitamin C Supplements, Vitamin E Supplements, Beta-Carotene Supplements, and Selenium Supplements for tests of other related products).

For example, Balance 600 was promoted with statements such as "Balance 600 can help reduce high cholesterol by ... helping reduce cardiac disease. Amino acids within Balance 600 help reduce arteriesclerosis by preventing damage to blood vessel walls and reducing the formation of dangerous lesions. Balance 600 can help reduce hypoglycemia by stabilizing and regulating blood sugar while increasing insulin levels and sensitivity." 

D-Limonene was promoted with statements such as "helps to successfully reduce cholesterol and dissolve gallstones. It is an anti-: fungal, microbial, parasitic, viral, and bacterial. D-Limonene is used in some cancer treatments because it is a cyclic monoterpene that induces Apoptosis (death of cancer cells). It may also inhibit tumor growth. Animals [sic] studies show activity of d-limonene against breast cancer, pancreatic, stomach, colon, skin and liver cancers. D-Limonene can also provide relief from acid reflux...and G.E.R.D." 

(See Pinoypharmacy.com's answer to the question Is there evidence that d-limonene can help fight cancer?)

Rapha Remedy was promoted with statements such as "be used as a soothing salve for treatment of the symptoms resulting from Eczema and Rosacea, Cracked, Dry, Itching and Burning Skin, Dandruff, Bed Sores and Sores from quadriplegic conditions, Chicken Pox, Shingles and Blisters, Diaper Rash, Cold Sores and Canker Sores, Psoriasis,..." 

Some of the company's products were also found to be misbranded because the company products failed to include adequate directions for its intended use(s). 

See related warnings:

Seller of 5-HTP, Chromium, Curcumin and More Warned for Drug Claims

Seller of Muscle Supplements and More Warned for Manufacturing Violations

Creatine Powder Containing DMAA Recalled

FDA Warns Seller of Acai, Garcinia & More for Drug Claims

FDA Warns Dr. Carolyn Dean of Drug Claims Made for Magnesium, Calcium & Other Mineral Supplements

To read the FDA's warning letter, use the red link below.


For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to .



 

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