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Posted May 14, 2014

Maker of Mood, Smoking Cessation Supplements and More Warned for Violations, Drug Claims

On April 17, 2014, the FDA issued a warning letter to CDJ Holding, Incorporated, d.b.a. Pacific BioLogic, following a facility inspection which found the company's products, including Grounded, Limbic Balance Morning Formula, Limbic Balance Evening Formula, TobacOff, and JittersAway, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. 

These violations include failure to establish identity specifications for each component used in the manufacture of a dietary supplement and failure to design a production and in-process control system to ensure that dietary supplements are manufactured in a manner that will ensure the quality of the dietary supplement.

In addition, statements made on labels and in promotional materials for Grounded, Limbic Balance Morning Formula, Limbic Balance Evening Formula, TobacOff, and JittersAway were found to be drug claims.

Grounded contains magnesium, niacin, potassium, vitamin B12, vitamin B6, zinc, betaine anhydrous, creatine monohydrate, GABA, glycine, L-carnosine, L-glutamine, lithium orotate, MSM and taurine. It was promoted to treat alcohol and drug withdrawal and mood disorders with statements such as "[G]rounded acts to mop up... neurotoxins, correcting the subtle brain damage caused by... addictions." 

(See's Reviews of Magnesium Supplements, Potassium Supplements, B Vitamin Supplements, Zinc Supplements, Creatine Supplements and Joint Health Supplements for tests of products that contain these ingredients.)

Limbic Balance Morning Formula contains biotin, folic acid, manganese, pantothenic acid, selenium, thiamin, vitamin A, vitamin D3, vitamin E, aspartic acid, boron, DMAE, phenylalanine, ginger extract, tyrosine, octacosanol, PABA, pepper extract, rubidium chloride and St. John's wort extract. Limbic Balance Evening Formula contains 5-HTP, black pepper extract, chamomile flower extract, hops flower extract, L-glutamine, melatonin, niacinamide, passion flower extract, vitamin A, thiamin, vitamin b12, riboflavin, niacin, vitamin B6, vitamin C and vitamin D3. Both supplements were promoted to treat alcohol and drug withdrawal, attention deficit disorder and obsessive compulsive disorder. 

(See's Reviews B Vitamin Supplements, Vitamin A Supplements, Vitamin C Supplements, Vitamin D Supplements, 5-HTP Supplements, Melatonin Supplements and St. John's Wort Supplements for tests of products that contain these ingredients.)

TobacOff contains polygala root, houttuynia leaf, Vietnamese sophora root and American ginseng root. It was promoted with statements such as "The main formula to regulate tobacco craving." 

JittersAway contains Dan Shen, Ye Jiao Teng, Long Gu, Suan Zao Ren, Zhen Zhu Mu, Mu Li, Yuan Zhi and Fu Shen. It was promoted with statements such as "Most people develop nervous jittery feelings during the process of eliminating nicotine from their system. Jitters Away... eases the intensity, and shortens the duration of withdrawal." 

(See's Review of Ginseng Supplements for tests of related products.)

TobacOff , JittersAway and other Pacific BioLogic products, including ArteClear Blood Pressure, Attack 1, Attack 2, Complexion, Calm & Clear, Cough, Diabet, EstraSpecial, Female Tonic, Fortify, GI Tract: Gastro-Soothe, Prostability, GynoEase, Hair, Hepato-C, Hepato-Detox, Orthoflex, Kidney Tonic, Lower Relief, Natura-Allergy, Natura-Bronchia, Natura-Mune, Natura-Mune 2, Natura-Sinus, Qi Tonic, Self Defense, Soothing Sleep, Upper Relief, Thyrise, Toxi-Solve and ArteClear Circulation 2, were also found to be misbranded because the labels failed to provide the correct serving size or other information required by federal regulations.

See Related Warnings:

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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