FDA Warning Letters: Specifications

Sample 2019 FDA Warning Letters. It's About Specifications! As we prepare for the end of the year, it's always good to look back at what issues have been hot button issues for FDA Warning Letters.  Knowing is the first step toward being prepared. There were over three thousand warning letters so far this year.  Many, if not most, are about tobacco or vapping.  But, DSHEA products were, as always, represented.  So were a few cosmetic products, but, I did not notice any warnings involving Medical Foods. I've picked out just a few DSHEA examples which appear typical to me. This year's themes include Specifications, not just for the Product but also for the Components and Label.  Yes, I've developed a new SOP (#25) covering Specifications for Labeling and Packaging. Also, have you seen my Specifications -- Testing -- Samples Webinar?  http://www.vitaminconsultancy.com/webinars.php The sample Warnings are below. After taking a look, review the services The Vitamin Consultancy offers and remember that we are running a 1/3-off year's end sale for all our services.  The services list is here:   https://vitaminlawyerarchives.blogspot.com/2019/11/vitamin-consultancy-services-discounted.html Do you have all of the Specifications the FDA expects to see? If not, it's time to talk to me... Call: 973.300.4594 or email me at ralph.fucetola@gmail.com Here are the Warning Samples (bold added) Revital U International, LLC Office of Human and Animal Food Operations West Division 3 CGMP/Dietary Supplement/Adulterated https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revital-u-international-llc-585256-10162019 The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... These violations cause your dietary supplement products to be adulterated ... in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. 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... ------- Paisley Farms, LLC dba Paisley Farm & Crafts Division of Human and Animal Food Operations East V CGMP/Dietary Supplement/Adulterated/Misbranded   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/paisley-farms-llc-dba-paisley-farm-crafts-575934-06042019 The United States Food and Drug Administration (FDA) inspected your facility ... During the inspection we collected product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder products.  Following the inspection... we reviewed your website ...r and your Facebook page...  Your website links directly to your Facebook page, and your Facebook page also links directly to your website, where you take orders for the products ... The claims on your Facebook page establish that the products are drugs ... because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Additionally, the product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder do not bear a statement of identity as a dietary supplement, a Supplement Facts panel, or other information suggesting that the product is intended to supplement the diet. ------------- Herbal Healer Academy, Inc. Division of Human and Animal Food Operations West III Unapproved New Drugs/Misbranded   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/herbal-healer-academy-inc-570957-09122019 FDA reviewed your website ...and has determined that you take orders there for the products HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA Herbalgesic, HHA CoQ10 with Hawthorn Berry, HHA Glucosamine & Chondroitin, Angiostop, HHA Beta Glucans, HHA Prostate Support and The Healing Formula Wound Care. In addition, FDA reviewed your product catalog following an inspection of your facility .... The claims on your website and within your product catalog establish that ... products are drugs ... because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. “Many people have reported relief from crippling arthritis in just 30 days using this product…” “Colloidal Silver has successfully controlled: … blood parasites, boils, candida, chronic fatigue syndrome (CFS), colitis, herpes, lupus, malaria, viral and fungal infections, rheumatoid arthritis, ringworm, shingles, yeast infections…” ---------- Ibitta Enterprises, Inc. Division of Human and Animal Food Operations West V CGMP/Dietary Supplement/Adulterated/Misbranded https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ibitta-enterprises-inc-584337-09272019 The significant violations documented during the inspection include, but are not limited to, the following: 1. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of 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 supplements... Specifically, you have not established such specifications for the dietary supplements you manufacture. Once you have established the required finished product specifications, you must verify that the specifications are met ..., and you must make and keep records of such specifications and the verification thereof ... 2. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, including identity specifications and specifications necessary to ensure the purity, strength, and composition of dietary supplements manufactured using the components... Specifically, you failed to establish identity specifications for most of the components you use in your dietary supplements, and you have not established any written specifications to ensure the purity, strength, and composition of your dietary supplements manufactured using the components. 3. You failed to establish specifications for the dietary supplement labels (label specifications)... Specifically, you have no written label specifications for your finished dietary supplement products. ----------- Alternative Laboratories Office of Human and Animal Food Operations East Division IV Dietary Supplement/Adulterated   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alternative-laboratories-586947-09182019 Our review of your product labels revealed that you declared the ingredient 2-amino-5 methylheptane and Octodrine as a dietary ingredient in several of the dietary supplements you manufacture, including Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa. The ingredients 2-amino-5 methylheptane and Octodrine are also called, among other names, 1,5-DMHA, 2-amino-6-methylheptane, 2-aminoisoheptane, 1,5-Dimethylhexylamine, 6- Amino-2-methylheptane, Amidrine, 2-Metil-6-amino-eptano, and 2-Isooctyl amine, and will be referred to hereinafter as DMHA. The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)]. Given that you have declared DMHA as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that DMHA is a “dietary ingredient” under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. If you have a basis to conclude that DMHA is a “dietary ingredient,” it would also be a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the Act [21 U.S.C. § 350b(d)].