# Shehadeh Giannamore, PLLC — FDA Compliance Made Easy > Shehadeh Giannamore, PLLC is a Florida-based FDA regulatory law firm led by attorney Katherine L. Giannamore, serving a global clientele since 2012. The firm helps companies achieve and maintain FDA compliance across foods, beverages, dietary supplements, cosmetics, drugs, OTC drugs, and medical devices — including ingredient and label reviews, marketing/website reviews, registrations, premarket submissions, import alert removals, and warning letter responses. This file contains the full text content of the site's key pages for use by LLMs and other automated systems. --- ## Home URL: https://giannamore-law.com/ At Shehadeh Giannamore, PLLC, we assist our global clientele with a wide range of regulatory issues, including label and ingredient reviews, FDA registrations, premarket notifications, or 510(k) submissions, removals from import alerts, reconditioning requests, responses to warning letters and a number of other services. In order to help individuals establish compliance with federal laws and regulations at the outset, we also provide reviews of products and marketing materials to ensure that these products are compliant with federal laws before they are marketed and sold in the United States. These reviews include ingredient and label reviews for many different types of products in all FDA-regulated industries. Some of the FDA-regulated products that we provide assistance with are foods, dietary supplements, medical devices, cosmetics and over-the-counter (OTC) drugs. FDA Compliance and Regulatory Guidance Services — establishing and maintaining FDA compliance with respect to: Foods, Beverages, Cosmetics, Dietary Supplements, Drugs, Medical Devices, and Over-the-Counter (OTC) Drugs. Contact: contact@sglawfl.com or (305) 507-9843. Available seven days a week; inquiries answered within 24 hours. --- ## About the Firm and Attorney Katherine Giannamore URL: https://giannamore-law.com/about-us-fda-consultant/ Focusing on food and drug law, Attorney Katherine Giannamore handles a wide range of regulatory issues, including ingredient reviews, label reviews, reviews of marketing (websites, brochures, video advertisements), removals from import alerts, reconditioning requests, responses to warning letters and a number of other services. In order to help individuals establish compliance with federal laws and regulations at the outset, the firm provides reviews of products and marketing materials for many different FDA-regulated industries, including all types of foods, dietary supplements, cosmetics and over-the-counter (OTC) drugs. Additionally, the firm provides registration and listing services, among many other regulatory and legal services. Ms. Giannamore has been heading the firm's Food & Drug Law Practice since its inception in 2012. Her entry into this field began even earlier, with her initial employment as a law student at a mid-sized Miami-based law firm, where she was one of a select few working in the firm's FDA practice group. This experience led Katherine to start her own firm focusing on helping clients achieve regulatory compliance while providing cost-effective legal solutions to a wide range of clients. Ms. Giannamore is licensed to practice law in the State of Florida and is admitted to practice before the United States Courts of Appeals for the Third Circuit and the Eleventh Circuit. While Katherine's primary focus is providing FDA regulatory consulting services and related regulatory guidance directly to clients, she has also completed several speaking engagements to help those in the industry understand the legal background of various FDA-regulated areas, including gluten-free labeling of foods and major allergen labeling under the Food Allergen Labeling and Consumer Protection Act, among other related regulatory topics. Contact: contact@sglawfl.com or (866) 785-0873. --- ## FDA Consultant Services URL: https://giannamore-law.com/our-services/fda-consultant/ Our FDA Consultant Services are comprehensive and industry- and product-specific to help clients develop products that are compliant with federal laws and regulations. From ingredient reviews to label reviews, FDA registration and marketing reviews, the firm provides extensive FDA Consultant Services to meet the needs of clients at every level and stage in the manufacturing and marketing process. Ingredient reviews are used to determine whether particular products, as currently formulated, may be legally marketed in the United States without further regulatory approval. Because some ingredients may only be used in products classified as drugs, it is important to know whether a formulation would cause a product to be regulated more stringently and require pre-approval. Because FDA regulations pertaining to labels are very detailed and complex, many companies look to FDA Consultant Services to help ensure compliance with FDA labeling requirements. **Ingredient Reviews:** Because products are regulated based on both their ingredients and intended use, ingredient reviews are often the first stage in determining how products are regulated. FDA also regulates the names of ingredients on product labels; under FDA regulations, ingredients generally must be declared according to their common or usual name. These requirements apply to foods, dietary supplements, and other FDA-regulated products like cosmetics. **Label Reviews:** The FDA has very specific requirements for the labels of the products it regulates — from the placement of information to the formatting of Nutrition Facts Panels and required statements such as the Net Quantity of Contents and Statement of Identity. Label reviews are a key way the firm helps clients ensure their product labels are fully compliant with FDA regulations. Contact: (866) 785-0873 or contact@sglawfl.com. --- ## Ingredient Reviews URL: https://giannamore-law.com/our-services/fda-ingredient-reviews/ Ingredient reviews are used to determine whether particular products, as currently formulated, may be legally marketed in the United States without further regulatory approval. Because some ingredients may only be used in products classified as drugs, it is important to know whether a formulation would cause a product to be regulated more stringently and require pre-approval. Because the FDA typically regulates products based on both their ingredients and intended use, ingredient reviews are often the first stage in determining how products are regulated. Under FDA regulations, ingredients generally must be declared according to their common or usual name. These requirements apply to foods, dietary supplements, and other FDA-regulated products. Certain ingredients must also be listed separately in accordance with major allergen declaration requirements — major food allergens must be listed on all food and dietary supplement labels, and products that fail to do so are deemed misbranded and may be subject to regulatory action. A FDA regulatory attorney can help by conducting ingredient reviews, which typically entail: 1. Researching various FDA and related databases to determine marketing options for a product; 2. Determining whether it is feasible to market the product legally, as formulated; 3. Providing guidance on the classification of the product based on its ingredients; and 4. Helping determine FDA-compliant ingredient declarations for use in product labeling. Contact: contact@sglawfl.com. --- ## FDA Label Reviews URL: https://giannamore-law.com/our-services/fda-label-reviews-2/ The FDA has very specific requirements for the labels of the products it regulates, including the placement of information on the Principal Display Panel (PDP), such as the Net Quantity of Contents and Statement of Identity. Label requirements differ based on product classification — for example, food labels must bear Nutrition Facts Panels, while dietary supplements (a subset of the food classification) must display Supplement Facts Panels. Because labeling regulations are complicated and highly technical, label reviews are a key way the firm helps clients ensure their product labels are fully compliant with FDA regulations. Services include: - Conducting FDA label reviews of draft and/or current product labels to determine compliance; - Providing an overview of changes needed to bring labeling into compliance; - Suggesting alternative wording to reduce the risk of FDA enforcement action; and - Conducting follow-up reviews of revised labels to confirm compliance. Contact: (866) 785-0873 or contact@sglawfl.com. --- ## FDA Imports URL: https://giannamore-law.com/our-services/fda-imports/ FDA imports are tricky — many products already selling in the EU and other countries would not meet FDA import requirements and could not be sold as-is in the United States. The firm provides legal and regulatory consulting services to help companies across the globe develop products that are compliant with FDA regulations, including ingredient/formulation reviews, labeling reviews, and product classification. Importers of FDA-regulated goods often find products subject to seizure and detention upon importation for failure to comply with labeling regulations and other FDA requirements, resulting in costly delays. However, it is often possible for these products to be reconditioned and released. Reconditioning is a process where the FDA allows importers of non-compliant products to bring goods into compliance with federal regulations; once compliance is achieved, products may be released and sold to consumers. A FDA regulatory attorney can help resolve import issues and reconditioning requests by: - Determining the exact reasons for detention of affected shipments; - Helping bring products into compliance with FDA regulations (including labeling and website statements); - Preparing and submitting a Reconditioning Request showing how products now comply; and - Acting as the contact person with the FDA regarding the Reconditioning Request. Contact: contact@sglawfl.com. --- ## Supplement Facts Panels URL: https://giannamore-law.com/our-services/supplement-facts-panels/ The FDA has very specific requirements for the labels of products it regulates, including the Supplement Facts Panels of dietary supplements. While food labels must bear Nutrition Facts Panels, dietary supplements (a subset of food) are required to display Supplement Facts Panels. Because labeling regulations are technical, label reviews are a key service the firm provides, including development of Supplement Facts Panels and ensuring all label components meet FDA requirements. Services include: - Reviewing current product labels for FDA compliance; - Providing an overview of changes needed for full compliance; - Suggesting alternative wording to reduce risk of agency action; and - Reviewing revised labels after the initial review. Contact: contact@sglawfl.com. --- ## Outer Packaging Requirements URL: https://giannamore-law.com/our-services/outer-packaging-requirements/ The FDA has very specific requirements for product labels, including statements required on the Principal Display Panel (PDP), such as Net Quantity of Contents and Statement of Identity. Label requirements differ based on product classification, and when products are packaged in both outer and inner containers, general labeling requirements may differ. Services to help with outer packaging requirements include: - Reviewing draft and/or current product labels for compliance; - Providing guidance on the FDA's outer packaging requirements; - Providing an overview of necessary labeling changes; - Suggesting alternative wording to reduce risk of agency action; and - Reviewing revised labels after the initial review. Contact: contact@sglawfl.com. --- ## Website Reviews URL: https://giannamore-law.com/our-services/website-reviews/ Because the FDA regulates products based on intended use and ingredients, an initial stage in determining how a product is regulated is looking at the intended use, which the FDA gleans from "claims" made about a product — statements made on labels, through infomercials or other marketing materials, and on product websites. The FDA considers websites to constitute part of the overall "labeling" of a product, meaning any statements made on a product website reflect on the product itself. It is critical to ensure a website does not contain impermissible product claims that could subject a product to heightened FDA regulation. Website review services include: - Conducting product website reviews (including linked websites) to ensure no impermissible claims are made; - Providing guidance on changes needed to remain compliant; and - Suggesting alternative language to reduce risk of FDA enforcement action. Contact: contact@sglawfl.com. --- ## FDA Label Reviews and Marketing Reviews URL: https://giannamore-law.com/our-services/fda-label-reviews/ FDA label reviews and marketing reviews help clients comply with FDA regulations and related federal laws. The FDA generally classifies products based on intended use and ingredients, with intended use often determined by "claims" made about a product through brochures, telemarketing, infomercials, and other media — all of which the FDA considers part of a product's overall "labeling." Services include: - Reviewing marketing materials to ensure no impermissible claims are made; - Providing guidance on changes needed to achieve FDA compliance; - Suggesting alternative language to reduce risk of FDA enforcement action; and - Conducting reviews of final marketing content to ensure compliance. Contact: contact@sglawfl.com. --- ## FDA Consultant Food Services URL: https://giannamore-law.com/fda-consultant-food-services/ The firm's FDA Consultant Food and Beverage Services are comprehensive, helping clients develop products compliant with federal laws and regulations, from ingredient reviews to label reviews, FDA registration, and marketing reviews. Ingredient reviews determine whether products, as formulated, may be legally marketed in the United States without further regulatory approval, since some ingredients may only be used in products classified as drugs. Label reviews address the FDA's specific requirements for label placement of information, Nutrition Facts Panel formatting, and required statements such as Net Quantity of Contents and Statement of Identity. Contact: (866) 785-0873 or contact@sglawfl.com. --- ## Nutrient Content Claims URL: https://giannamore-law.com/our-services/nutrient-content-claims/ Nutrient content claims are particular claims made about the ingredients found in products and their nutritional value. Because different types of claims (health claims, disease claims, structure-function claims) can cause a product to be subject to heightened regulation — for example, disease claims on an otherwise-food product will cause the FDA to classify it as a drug — it is critical to understand which claims may be used for a particular product and to ensure they are properly worded. Services include: - Reviewing product labeling, websites, and marketing materials for compliance; - Helping develop nutrient content claims in compliance with federal requirements; - Providing guidance on necessary changes to claims; and - Suggesting alternative language to reduce risk of FDA action. Contact: contact@sglawfl.com. --- ## Organic and Natural Claims URL: https://giannamore-law.com/our-services/organic-and-natural-claims/ In addition to intended-use claims, certain claims are made about the ingredients found in a product, such as organic and natural claims. Understanding the types of claims under FDA regulations helps avoid improper claims that could cause heightened regulation. Services include: - Reviewing product labeling, websites, and marketing materials for compliance with FDA and other government agency requirements; - Providing guidance on changes needed to achieve and maintain compliance; and - Suggesting alternative language to reduce risk of FDA enforcement action. Contact: contact@sglawfl.com. --- ## Dietary Supplement Consultant and Attorney Services URL: https://giannamore-law.com/our-services/dietary-supplement-consultant-attorney-services/ The firm's FDA Dietary Supplement Consultant and Attorney Services are comprehensive and product-specific, covering ingredient reviews, label reviews, website reviews, and more, to meet client needs at every stage of manufacturing and marketing. Ingredient reviews determine whether products may be legally marketed without further approval; with dietary supplements, only certain ingredients may be used in formulations or the product risks being deemed adulterated under federal law. Label reviews address the placement of required information, formatting of Supplement Facts Panels, and required statements such as Net Quantity of Contents and Statement of Identity. Contact: (866) 785-0873 or contact@sglawfl.com. --- ## Structure Function Claims URL: https://giannamore-law.com/our-services/structure-function-claims/ Structure function claims are key statements made about nutritional supplements and vitamins. Certain claims called "structure function claims" may be made about dietary supplement products and, if done correctly, will not cause these products to be subject to heightened regulation (unlike disease claims, which can cause a food to be classified as a drug). Services include: - Reviewing product labeling, websites, and marketing materials for compliance; - Providing guidance on changes needed to remain compliant; and - Suggesting alternative language to lessen risk of FDA enforcement action. Contact: contact@sglawfl.com. --- ## Disease Claims URL: https://giannamore-law.com/our-services/disease-claims/ If a product is otherwise classified as a food but its labeling contains disease claims, the FDA will classify the product as a drug. Understanding the types of claims under FDA regulations helps avoid making disease claims that could inadvertently cause a product to be regulated as a drug. Services include: - Reviewing product labeling, websites, and marketing materials for compliance; - Providing guidance on necessary changes to claims; and - Suggesting alternative language to reduce risk of FDA action. Contact: contact@sglawfl.com. --- ## Health Claims URL: https://giannamore-law.com/our-services/health-claims/ Understanding the types of claims under FDA regulations helps avoid making improper health claims that could cause products to be regulated more strictly. Health claims, disease claims, and structure-function claims are each treated differently by the FDA depending on wording and context. Services include: - Reviewing product labeling, websites, and marketing materials for compliance; - Providing guidance on necessary changes to remain compliant; and - Suggesting alternative language to reduce risk of FDA action. Contact: contact@sglawfl.com. --- ## FDA Warning Letter Responses URL: https://giannamore-law.com/our-services/fda-warning-letter-responses/ FDA-issued warning letters are usually the FDA's first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Recipients are given fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations — including violations not explicitly cited in the letter. Firms must not only detail corrective measures but also actually take the steps necessary to correct the issues. Failure to respond appropriately may result in more formal enforcement measures. Services include: - Reviewing the legal and regulatory basis for the warning letter; - Determining appropriate corrective measures to reestablish compliance; - Drafting and preparing a warning letter response within the required time frame; - Communicating with the FDA on the client's behalf; and - Providing ongoing guidance toward achieving compliance. Contact: contact@sglawfl.com. --- ## 30-Day Notification – Dietary Supplements URL: https://giannamore-law.com/our-services/30-day-notification-dietary-supplements/ Dietary supplements may make "structure-function claims" on labeling provided that: (1) the claim includes a mandatory disclaimer, (2) the claim is truthful and not misleading, and (3) the firm has notified the FDA within 30 days of marketing the product bearing the claim (30-day notification, also known as a DSHEA notification under the Dietary Supplement Health and Education Act). Services include: - Drafting and preparing the 30-day notification in accordance with FDA regulations and guidance documents; - Submitting the notification and acting as contact person with the FDA; and - Handling any related FDA communications after submission. Contact: contact@sglawfl.com. --- ## Premarket Approval (PMA) URL: https://giannamore-law.com/our-services/premarket-approval-pma/ The FDA regulates medical devices on a three-tier, risk-based approach. Class III (high-risk) medical devices typically require submission of a Premarket Approval application ("PMA"), a more rigorous process than premarket notification because it requires the device sponsor to demonstrate safety and effectiveness based on scientific evidence. Once a device has an approved PMA, the sponsor may refer to the device as "FDA Approved." Services include: - Determining whether premarket approval is necessary for a particular device; - Researching applicable guidance documents for the device type; and - Consulting on the requirements for PMA review. Contact: contact@sglawfl.com. --- ## 510(k) / Premarket Clearance URL: https://giannamore-law.com/our-services/510k-clearancepremarket-notification/ The FDA regulates medical devices on a three-tier, risk-based approach. Class I devices generally do not require FDA clearance before marketing but are still regulated. Premarket notification, or "510(k) clearance," is a prerequisite for marketing most Class II devices — device sponsors must demonstrate substantial equivalence to a previously cleared "predicate device" or to a device marketed before May 28, 1976. Services include: - Reviewing the device to determine appropriate predicate device(s); - Drafting and preparing the 510(k) submission per FDA guidance documents; - Submitting the premarket notification and acting as contact person; - Communicating with FDA staff regarding the submission; and - Preparing responses to FDA requests for additional information. Contact: contact@sglawfl.com. --- ## Food & Drug Blog URL: https://giannamore-law.com/blog/ Articles on FDA enforcement, labeling rules, warning letters, and regulatory developments across food, drug, cosmetic, tobacco, and medical device law. Recent topics include cosmetic registration changes, tobacco sales age increases, JUUL marketing violations, Alzheimer's supplement claim warning letters, and major food allergen labeling changes. Note: Blog content is for general informational purposes only and is not updated after publication; it does not constitute individualized legal advice or create an attorney-client relationship. --- ## Contact Us URL: https://giannamore-law.com/contact/ The firm handles regulatory matters for clients throughout the United States and across the globe, for both imported and domestic products. Initial consultations are always free of charge. Available seven days a week via contact form, and inquiries are answered within 24 hours. Phone: (305) 507-9843 / (866) 785-0873 (toll-free) Email: contact@sglawfl.com --- Note: All content on this site and blog is for informational purposes only, may not reflect the most current legal and regulatory developments, and does not create an attorney-client relationship. Individuals with specific FDA legal or regulatory issues should contact the firm directly for a consultation.