Is Sanapac Co., Inc. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

“VITAMIN B-12…helping to prevent anemia…”

“VITAMIN C… helps heal wounds, scar tissue and fractures, builds resistance to infections, aids in the prevention and treatment of the common cold... It may decrease the risk of some cancers.”

“SARSAPARILLA…is an important aid for cystitis and renal colic from kidney stones. It is also used in the treatment of eczema…dermatitis and psoriasis.”

Potential Health Risks

“Vitamin A- (Beta Carotene)…repair of body tissues. It helps maintain smooth, soft skin and helps protect the mucous membranes of the mouth, nose, throat and lungs, thereby reducing susceptibility to infections. Current medical research shows that foods rich in Beta Carotene may help reduce the risk of lung cancer, certain oral cancers and is known to have beneficial effects on vision.”

Your Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)], in that the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements.

Regulatory Context

You failed to establish the required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70. Specifically,You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come into contact with the dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement as required by 21 CFR 111.70(d). Specifically, you have no specifi

You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come into contact with the dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement as required by 21 CFR 111.70(d). Specifically, you have no specifications for dietary supplement labels and packaging for the labeling and packaging operations you perform for your dietary supplement products.

You failed to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, although your firm creates the formulations that your contract manufacturer manufactures on your behalf, you have no specifications for any of your dietary supplement formulations for the identity, purity, strength, and composition, or limits on those types of contamination that may adulterate, or may lead to adulteration for the finished batch of dietary supplements received from you