EAS is a leading provider of regulatory consulting services to the dietary supplement industry for adherence to the Dietary Supplement Health and Education Act (DSHEA) of 1994 which was passed by the United States Congress in 2007. EAS offers the best in development of regulatory strategies and submissions assistance. We design clinical studies to substantiate claims made on dietary supplement labels and conducts scientific literature reviews in the preparation of petitions for FDA approvals of conventional and qualified health claims for dietary supplement ingredients. EAS will also prepare New Dietary Ingredient Notifications (NDINs) for FDA review as required in 21 CFR 190 and serve as the US Agent for foreign dietary supplement firms distributing product within the U.S.
We assist firms with Quality System Development, the establishment of both raw and in-process specifications, stability program development, Quality Agreement preparation and more. From the preparation of NDI notifications for FDA review, and serving as the US Agent for the registered dietary supplement firm, to assisting with the GMP Compliance, our expert consultants can help your firm stay compliant with FDA regulations.
The establishment of regulation 21 CFR part 111, or Current Good Manufacturing Practices, in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements requires persons involved in the manufacture, packaging, labeling or holding of dietary supplements to follow certain practices to ensure quality.
GMPs are a system of procedures and documentation, written or analytical, to ensure the product produced has the identity, strength, quality, and purity which it purports or is represented to possess. In 21 CFR 111, there are procedures, required documents, and records that must be developed and maintained to minimally comply with the regulation. Firms must maintain appropriate operating procedures and records for the running of the physical plants and grounds, equipment and utensils, various production process control systems as well as holding and distribution and handle customer complaints and more. Sanitation, pest control, employee training, and supervision are also covered under GMPs.
We assist firms with the development and implementation of Quality Systems necessary to comply with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. This includes the establishment of raw material, packaging component, in-process material, and finished product Specifications to ensure that the quality of the finished dietary supplement meets the requirements for identity, purity, strength, composition, and limits of potential contaminants; the preparation of thorough and detailed Master Manufacturing Records that will be used for the consistent manufacture, packaging, and labeling of each batch of product documented in the Batch Production Record; and the design of an organized, cohesive Quality Incident System to address quality issues such as Out of Specification results, Deviations, Returned Dietary Supplements, Consumer Product Complaints, and other quality issues that may result in Non-Conforming Products that require a Material Review and needed Corrective and Preventative Actions. Given our extensive experience, EAS can also assist with ensuring that contract manufacturing/packaging/testing and distribution partners are fully GMP compliant through the preparation of a Quality Agreement and supplier qualification program that includes on-site audits of partner facilities by experienced EAS auditors.
FDA specifies what must be included on a dietary supplement label as well as how it must be displayed. The various requirements for information coupled with the typically smaller size of a dietary supplement label and packaging can make for, at times, a complicated puzzle of fitting the pieces together in a compliant manner. A lack of compliance can cause your product to be considered misbranded and subject to regulatory action and penalties.
Our team of labeling experts will also ensure that finished dietary supplement product labels meet the requirements dictated in 21 CFR 101, Food Labeling, while formulation experts provide guidance and recommendations on necessary intentional overages and manufacturing process strategies to ensure that all label claims are met upon release and throughout the product shelf life as demonstrated through a robust and scientifically sound dietary supplement Stability Program.
EAS Consulting Group can design or review your company’s label and package inserts to ensure compliance with FDA regulations for all manner of health claims, structure-function claims, nutrient content claims, appropriate formatting, allergens. Also, EAS is available to assist dietary supplement firms in the preparation of 30-day notification of claims for submission to the FDA.
In the unfortunate event of a recall, EAS consultants can help walk your company through the steps of the recall process to ensure FDA compliance. Whether the infraction is a Class I, II or III recall, EAS can assist in making this challenging process more streamlined and act as a conduit of information between your company and FDA.
Dietary supplements, including dietary ingredients, are legally considered foods and subject to the same food facility registration requirements as food products. Like domestic facilities that manufacture, process, package or hold dietary supplements, Foreign Facilities must also register with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
In addition, foreign facilities must have a US Agent located in this country to serve as a communication link with FDA and them and to oversee their facility registrations. EAS provides a US Agent and assistance with origin Facility registration, serving as a conduit for communications between FDA and the foreign facility.
A manufacturer or distributor of a New Dietary Ingredient (NDI), or a dietary supplement that contains the NDI, is required to submit a premarket notification to FDA at least 75 days before the product enters the market, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered”. The FDA is then able to evaluate whether it is reasonably expected to be safe.
NDI Notifications, much like food GRAS submissions are technical, requiring extensive supporting safety data as part of the packet submission to FDA. Our team of former FDA consumer safety officers and toxicologists are available to prepare and submit NDIs to FDA for review.
FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace.
EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.
In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.
Did you know that your company can be held liable for claims made by third parties on social media?
EAS Consulting Group can review your marketing for FDA compliance, making sure there are no egregious or illegal claims of structure-function, health benefits or other inaccuracies that need be corrected.
EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need. Let bring one of our in-house training programs to your facility, customized for your specific needs, or join us at one of our upcoming training programs coming to a city near you.
- Dietary Supplement Good Manufacturing Practices (GMP) Seminar
- Dietary Supplement Good Laboratory Practices (GLP) Seminar
- Dietary Supplement Labeling Compliance Seminar
- FSMA Part 117: for Dietary Supplements
In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.
EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.
EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.