compliance regulatory usa

Dietary Supplements, Food and Beverage Products

USFDA Food Facility Registration

In the USA, food, beverage and dietary supplements are regulated by the US Food and Drug administration (US FDA). Any facilities that manufacture, process, pack, or store these products in the US and outside must be registered with the US FDA before sale or consumption of products in the US. The FD&C Act was modified in 2011 by the Food Safety Modernization Act (FSMA), where an inspection of the facility by FDA is permitted upon registration.

Our team of experts at Stelioz can help facilities in the US and outside of the US to get the FDA Food Facility registration approved and review facilities for GMP compliance. We can also provide US agent services for facilities outside of the USA, to comply with FDA regulations. Our services include:

  • Review of facility (procedures, operations) for FDA compliance, prior to FDA inspection
  • Develop protocols such as SOPs, Preventive Control Plans (PCP) as required
  • Provide GMP training to staff Develop supplier verification protocol and review supplier documentation
  • Application for FDA Food Facility Registration
  • Renewal of Food Facility Registration
  • Provide and facilitate coordination with US FDA agents for facilities outside of the US.

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Health Claim Substantiation/Structure Function Claims​

The right claim on your product can be a powerful marketing tool, a concise means of informing your consumers of the benefits of your product. Structure function claims appear on nutraceutical products and foods often. The Dietary Supplement Health and Education Act (DSHEA) has established the regulatory requirements under which a structure function claim can be made:

  • To show the ability of a dietary ingredient or nutrient to influence the normal structure or function of the body
  • To characterize how the dietary ingredient/nutrient maintains this structure or function or maintains general health and well being
  • To demonstrate how supplementation of a dietary ingredient or nutrient prevents its deficiency (provided it is described how widespread the deficiency is in the US)

Our experts can help you gather the scientific evidence required for your health claim, review the regulatory documentation and submit your health claim notification to the US FDA.

Food Compliance, Safety and Quality Consulting

Regulatory and quality compliance comes into play far before the product enters the market. It helps to have foresight of the challenges that will be faced post market, and consider the desired claims and quality aspects of a product all the way back to product conception. We work with our clients from ground up to ensure all compliance, safety and quality aspects of a product are built into the operations. Here’s how we do it:

  • FDA food facility registration and renewal
  • GMP compliance- review of operations and quality processes, product testing and stability testing protocols
  • Hazard Analysis and Critical Control Points (HACCP) plan preparation, including Preventative Control Plan preparation
  • Product import and export requirements, including prior notices
  • Label compliance- content creation, review, supplement facts panel and claim verification
  • Temporary Market Authorization (TMA) support
  • Post market follow ups and regulatory support

New Dietary Ingredient (NDI) Notification

‘Dietary ingredients that were not marketed in the United States before 1994’ are termed as New Dietary Ingredients. Manufacturers and distributors must notify the US FDA about these ingredients or products containing these ingredients prior to marketing and distribution of a product. The food and nutraceutical industry has seen a large influx of novel ingredients in recent times. It is imperative for the manufacturer and consumer to get clarity on the safety and efficacy guidelines for a new ingredient, and prevent confusion and misinformation in the market.

The application process for NDIN can be difficult to navigate. At Stelioz, we can help manufacturers and distributors get clarity and submit applications using these steps:

  • Identify whether the substance of interest can be classified as a dietary ingredient
  • Identify whether the dietary ingredient is a ‘new dietary ingredient’, and the final product for marketing can be classified as a ‘dietary supplement’
  • Gather and compile scientific evidence for proving safety and efficacy of dietary ingredient, pertaining to its intended use and claims
  • Coordinate and facilitate a pre-submission meeting with FDA if desired
  • Prepare and submit final dossier for New dietary ingredient notification (NDIN)
  • Follow up with any requests for information by FDA in the application process

GRAS Notification

There are two ways to approach whether an ingredient can be approved as Generally Recognized as Safe (GRAS):

  • Submission to the US FDA and the US FDA conducts an assessment and issues a letter
  • Self- affirmed GRAS: Provide US FDA scientific evidence that the use of a substance is well established and there is consensus among a qualified expert panel that the evidence is sufficient to ensure the substance is safe under the conditions for its intended use

In both cases, it is important to note that GRAS status pertains to the intended use of an ingredient, not the ingredient itself. In the first case, where evidence has been collected and the use of the substance has been determined as GRAS by a person or company, the US FDA is informed of this determination by a ‘GRAS notification’ where US FDA then evaluates the information provided. Following its decision, the US FDA then issues a letter stating:

  • It does not question the notifiers GRAS determination or
  • The notification lacks sufficient evidence for the determination of GRAS status

To navigate this process efficiently, it is important that the notification submitted to the US FDA provides complete information regarding the safety of the substance for use in food products, and safety, efficacy of the substance with regards to its intended use.

Our expertise with US FDA compliance can help you provide comprehensive evidence for your GRAS notification(s). Our services include:

  • Reviewing the substance and its intended use, to determine if GRAS status is essential and feasible
  • Collection and review of scientific evidence to support safety and intended use of substance
  • Compilation of complete application dossier for submission to the US FDA
  • Facilitate a pre-submission meeting with the US FDA to ensure complete and accurate information in your GRAS notification dossier

Label Preparation, Compliance/Label Review

Dietary supplements and Natural health product labelling for products marketed and sold in the US requires the labels to be compliant with US FDA regulations. It is extremely critical that product labels are thoroughly checked to have the required disclaimers and language on their labels, with the correct format for ingredients displayed to avoid receiving warning letters from the US FDA or the product recalled for non-compliance and or misbranding. We can help you design and maintain product labels within these guidelines. Our services include:

  • Label design (including logo design and label graphics)
  • Label content preparation as per the US FDA regulations (including nutrition and supplement facts panel)
  • Final label review prior to market launch

Website and Marketing Content Review

Regulatory compliance does not end with product labels. As per the US FDA regulations, all marketing content, including digital content such as website descriptions, product write-ups, ads, pamphlets and any other form of marketing must comply with the regulations set out for dietary supplements. In addition to regulatory compliance, accurate and well-informed scientific content can go a long way in promoting a brand and encourage sustained confidence from consumers.

At Stelioz, we provide services that cover regulatory and scientific aspects of your marketing content. Our services include:

  • Preparation of SEO optimized product descriptions, blogs, ads, social media posts, and write ups for the marketing team
  • Preparation of monographs, white papers and other technical sheets
  • Review of your existing website and marketing content for scientific accuracy, and regulatory compliance, including health claim language, recommended use and cautions and warnings
  • Assisting your marketing team to provide optimal content that fully leverages the benefits of your product and/or services

Amazon, Retailer and Distributor Compliance

Dietary Supplements:

In keeping with USFDA policies, the Federal food, drug and cosmetic act (FD&C Act) and the Dietary Supplement Health and Education Act (DSHEA), Amazon requires all dietary supplements to be compliant with 21 CFR 101.36 and 21 CFR 111 code of regulations before being listed on its website, as per their Amazon Seller policies. If you have received a compliance request from Amazon Seller, or you would like to list your product on Amazon, we can help you with your listing, ensuring federal and local regulatory compliance in keeping with Amazon policies. Our services include:

  • Review of Certificates of Analysis and coordination with third party labs (ISO/IEC 17025 accredited)
  • Review of product images to be used for listing
  • Preparation and review of draft of ‘Letter of Guarantee’ and ensure accuracy of content as per the US FDA and Amazon requirements
  • Compile and supplement additional documents if finished product testing of active ingredients is not possible
  • Review product listing, including product description, listed ingredients and health claims to ensure compliance with Amazon Seller policies


Amazon Seller has certain policies in place for the sale of cosmetics, in keeping with the US FDA and local laws. These policies pertain to the packaging, formulation, labelling and description of products listed. These are some of the basic requirements:

  • Packaging- should be new, sealed in original manufacturer’s packaging with identifying codes and lot numbers
  • Labelling- must comply with the US FDA’s Summary of Labelling Requirements and Cosmetics Labeling Claims
  • Formulation- cosmetics must be free from ingredients listed in the US FDA Prohibited and Restricted Ingredients section (eg. products that release formaldehyde, eye products with permanent dye, mercury, toxic air contaminants etc.). Cosmetics should not require a prescription, contain any controlled substances, plastic microbeads, more than 12% hydrogen peroxide or ingredients sourced from sharks, whales, dolphins or porpoises

Our experts can help you navigate Amazon Seller and the US FDA policies and ensure your product listings are within regulations. Our services include:

  • Product review and classification
  • Label Preparation
  • Review of label and packaging
  • Review of product formulation and ingredients to ensure US FDA and Amazon Seller compliance
  • Product listing- review of description, marketing content and health claims
  • Review of product testing documentation

Food and Beverage Products:

Food products and beverages listed on Amazon must comply with federal and local laws, in addition to Amazon Seller policies. Some of these policies include:

  • Organic products must comply with USDA 7 CFR 205 organic regulations
  • Products must be properly packaged and sealed, and shipped in appropriate conditions to maintain their quality and safety

Food packaging must include basic product information- product name, company name and address, expiration date, net quantity and weight

  • Food products and beverages must not contain products that do not meet federal import requirements or infant formulas that do not meet the US FDA requirements
  • Shipping information must include details about the sender, receiver, and a statement of contents

Our product and regulatory experts can help you ensure compliance with these policies. Our services include:

  • Product review and classification
  • Label Preparation
  • Review of label and packaging
  • Review of product formulation and ingredients to ensure US FDA and Amazon Seller compliance
  • Product listing- review of description, marketing content and health claims
  • Review of product testing documentation

Cosmetics and Personal Care

Cosmetics in the US fall under the purview of FDA’s Federal Food, Drug and Cosmetics Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws outline which products can be classified as cosmetics, how these products should be labeled so as to convey their intended use. The US FDA specifically prohibits the marketing of adulterated or misbranded cosmetics. It is the duty of manufacturers and sellers of cosmetics to ensure their product is safe, and it is advised that appropriate tests be performed to ensure safety of the product, including toxicological data available on individual ingredients and similar product formulations. Additionally, warning statements are required on the label of certain cosmetics, and all cosmetics should adhere to restricted use or prohibition of certain ingredients as per CFR code of regulations. Although cosmetic products marketed in the US do not require a pre-market approval, FDA encourages companies to register their products as well as their manufacturing and packaging facilities with FDA’s Voluntary Cosmetic Registration Program (VCRP).

We can help review your cosmetics and ensure compliance with FD&C Act and FPLA regulations. Our services include:

  • Product review and classification
  • Review of label and packaging (Including label preparation if required)
  • Review of product formulation and ingredients to ensure FDA
  • Product listing- review of description, marketing content and health claims
  • Review of product testing documentation
  • Registration of product and/or manufacturing, packaging facility with the Voluntary Cosmetic Registration Program (VCRP)