FDA Warning letters – the list you don’t want to be on

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Buster Creative list of FDS warning letters

As a marketing and creative agency working in the healthcare industry, we’re aware of the tight regulatory environment in which our clients operate. So, we track the FDA warning letter list to see who has been cited recently to learn from the mistakes of others.

The 2013 list can be found here, but the list below highlights a few relevant violations.

Entrenet Nutritionals Inc., misbranded drugs, “The therapeutic claims on your product labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act”

SmartPractice Denmark AS, misleading marketing materials, “With the exception of your final reference manual (78314) and a sales aid (78199-A), your promotional materials are all false or misleading because they omit risk information”

Glucorell, Inc., improper marketing claims, “The therapeutic claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act”

Realm Labs LLC, misleading labeling, “Specifically, your NeuRemedy products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling for these products is false or misleading in that they are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in 21 CFR 101.9(j)(8)”

Keystone Laboratories, Inc., mislabeling, “Your ULTRA GLOW skin care products are also misbranded under Section 502(c) of the Act [21 USC 352(c)] because their labeling includes both English and French but some of the information required under authority of the Act appears only in English and not in French.”

Lodato Gennaro & C S.p.A., mislabeling, “FDA collected labels for several of your products. Based on our review, we have concluded that these products are adulterated and misbranded”

W.H. Walker & Sons, Inc. mislabeling, Your “Crow Hill??? apple cider is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient as required by 21 CFR 101.4(b). Specifically, the information panel on your product label does not bear an ingredient statement that includes the added preservative Potassium Sorbate which is an ingredient in your product.”

Pishon Trading Inc dba Eyezone, improper labeling, “Our evaluation found that, while the labeling contains some of the elements required of FDA-cleared or approved contact lenses, it is paraphrased, incomplete, and inaccurate in detail. Specifically, it does not contain a professional fitting guide, which is necessary as these are prescription devices. Moreover, the patient labeling does not identify care instructions for cleaning, disinfection, or wearing schedules. Additionally, the labeling does not include specific precautions or warnings.”


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