On December 21, 2023, the FDA issued a Warning Letter to Curtis Jacquot, dba Pacific BioLogic Co. following an inspection of the company’s manufacturing facility, which found the company’s products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). Violations noted by the FDA include failure to prepare and follow a written master manufacturing record for formulation of dietary supplements, failure to review all product complaints, failure to make and keep records of material review, failure to ensure that manufacturing, packaging, labeling, and holding operations ensure the quality of dietary supplements, and more.

In addition, the FDA reviewed the company’s websites and found statements about the company’s products, including ArteClear Circulation 2, Headache Release, Natura-Mune – 2, Pain Release, and Attack 2, to be drug claims, which are not permitted for dietary supplements.

For example, Headache Release was promoted with statements such as, “…Pacific BioLogic’s Headache Release formula offers natural relief for headaches and migraines.” and “…May be helpful to prevent onset of a migraine if taken at the onset of symptoms.”

See ConsumerLab’s answer to Do any supplements or foods help with migraine? Do any trigger migraine? for more information about related products.

Nature-Mune — 2 was promoted with statements such as, “More recently there have been extensive clinical studies that have identified a number of compounds in them [fungi and mushrooms, ingredients in Natura-Mune 2] that ... inhibit bacterial, viral, and tumor growth.” and “Cat’s Claw and Pau d’Arcu[sic] [ingredients in Natura-Mune 2] are two well-known (and studied) South American herbs that have some similar properties. They have been used extensively to treat chronic illnesses and degenerative conditions.”

See ConsumerLab’s Review of Reishi Mushroom Supplements for more information and tests of related products.

Also see: Does cat’s claw have health benefits and is it safe?

The FDA also stated in its letter that it considers most of these products to be “new drugs” because they are not recognized as safe and effective for their intended use. Additionally, most products were also found to be misbranded because the labels failed to include adequate directions for their intended use or failed to comply with labeling requirements for dietary supplements. For example, Pain Release product labels declare “Boswellia resin” and “Notoginseng,” but these are not the common names of these dietary ingredients. Grounded product labels declare “MSM,” and ArteClear Circulation 2 product labels declare, “BioPerine ® (Trademark of Sabinsa Corp.),” which are not common names for these ingredients.

See ConsumerLab’s Reviews of Joint Health Supplements, Ginseng Supplements, and Turmeric and Curcumin Supplements and Spices for more information and tests of related products.

For more information, use the link below.

Warning: Curtis Jacquot dba Pacific BioLogic Co.

See related recalls and warnings:

Lone Star Botanicals Warned by FDA for Manufacturing Violations

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NutraCaps Labs Warned for Unsafe Ingredients and Manufacturing Violations

InnoMark Warned for Manufacturing & Misbranding Violations

Moor Herbs, Inc Warned for Manufacturing Violations, Drug Claims