Every regulatory challenge is different. The companies we work with range from emerging supplement brands navigating their first FDA registration to established importers managing enforcement actions that threaten their entire supply chain. What they share is a need for practical, experienced regulatory counsel — and real results.
Below are representative examples of the matters Capote Law Firm has handled on behalf of clients. Client names and identifying details have been omitted or generalized to protect confidentiality.
FDA Warning Letter Response — Dietary Supplement Manufacturer
The situation: A Florida-based dietary supplement manufacturer received an FDA warning letter citing multiple cGMP violations observed during a facility inspection, including failure to establish specifications for finished products and inadequate batch production records. The company had received a Form 483 following the inspection but had not responded adequately, leading to the warning letter.
What we did: We reviewed the warning letter against the inspection records and identified which observations were fully substantiated and which contained regulatory overreach. We worked with the client to implement immediate corrective actions — revised SOPs, retraining of production staff, updated batch record templates — before drafting the response. Our written response addressed each observation specifically, with supporting documentation, and contested two observations where the FDA’s regulatory interpretation was not well-founded.
The outcome: The FDA closed the matter without further enforcement action. The client has since passed two subsequent routine inspections without receiving a Form 483.
Import Alert Removal — Dietary Supplement Importer
The situation: An importer of dietary supplement ingredients manufactured overseas found all incoming shipments from its primary supplier placed on FDA Import Alert 54-15 (import alert for adulterated dietary supplements) following a failed FDA analysis. Every shipment from that supplier was subject to automatic detention, halting the client’s operations.
What we did: We analyzed the basis for the Import Alert and identified that the FDA’s testing had detected a contaminant that was present in the raw material but could be controlled through enhanced supplier qualification and testing protocols. We worked with the client and its supplier to implement additional testing at an ISO 17025-accredited laboratory, develop a corrective action plan acceptable to the FDA, and submit a comprehensive petition for removal from the Import Alert with full documentation of the corrective measures.
The outcome: The supplier facility was removed from the Import Alert after submission of the petition and supporting documentation. The client’s supply chain was restored.
MoCRA Compliance Program — Multi-Brand Cosmetics Company
The situation: A cosmetics company operating four brands with a combined product portfolio of over 80 SKUs had not yet addressed MoCRA requirements when it approached Capote Law Firm. The company was manufacturing through two contract manufacturers — one domestic, one in South Korea — and was uncertain whether its manufacturers had completed facility registration or whether the company itself needed to register.
What we did: We conducted a full MoCRA compliance audit across all four brands, confirmed the registration status of both manufacturing facilities (one had registered, one had not), and identified the company’s obligations as the “responsible person” for all 80+ SKUs. We coordinated the foreign manufacturer’s FDA registration, submitted product listings for all SKUs, developed an adverse event reporting procedure, and reviewed the company’s safety substantiation files — identifying gaps that needed to be addressed before any FDA inquiry.
The outcome: The company achieved full MoCRA compliance across all four brands within 90 days, including facility registration, product listing, and a functional adverse event reporting system.
FDA Labeling Compliance — OTC Drug / Cosmetic Combination Product
The situation: A skincare brand was preparing to launch a new product that contained both sunscreen (an OTC drug ingredient) and cosmetic ingredients. The company was uncertain whether the product needed to comply with drug labeling requirements in addition to cosmetic labeling, whether its manufacturing facility met OTC drug cGMP requirements, and whether its marketing claims — including claims about wrinkle reduction and skin brightening — were permissible.
What we did: We advised the client that the sunscreen ingredient rendered the product a combination drug-cosmetic subject to the OTC sunscreen monograph, which imposed specific labeling, testing, and manufacturing requirements. We conducted a full label review, identified which of the company’s marketing claims were permissible (cosmetic claims about skin appearance) and which needed to be modified or removed (claims that crossed into drug territory). We also advised on the manufacturing requirements the contract manufacturer needed to meet to produce the product legally.
The outcome: The product launched with a fully compliant label and marketing program. The client avoided the enforcement exposure that would have resulted from launching with its original label and claims.
Amazon Listing Reinstatement — Dietary Supplement Brand
The situation: A dietary supplement brand had three of its top-selling products suspended from Amazon following Amazon’s detection of disease claims in the product descriptions. The brand had used claims like “supports healthy blood sugar levels already in normal range” — which Amazon’s systems flagged as an implied disease claim — alongside several other claims that the company believed were legitimate structure/function claims.
What we did: We reviewed all three product listings and the underlying FDA regulations on structure/function claims. We revised the claims language for all three products to be clearly within the permissible structure/function claim framework, updated the labels to include the required disclaimer, and drafted a Plan of Action for Amazon explaining the regulatory basis for the revised claims and confirming the corrective actions taken.
The outcome: All three listings were reinstated within two weeks of submitting the Plan of Action. The revised claims have not been flagged in subsequent Amazon reviews.
Facing a similar challenge? Capote Law Firm has been handling FDA regulatory matters since 2006. Schedule a free consultation or call (786) 207-1174 to discuss your situation.