Providing regulatory services throughout the life cycle of FDA-regulated products, from labeling and advertising, to post-marketing obligations and enforcement actions.
Food & Beverage
Import / Export
Warning letter / Detention
Adverse event reporting
Warning letter / Detention
FDA registration & listing
OTC monograph analysis
FDA registration & listing
Frequently Asked Questions
Food, Beverage, and Dietary Supplement
The FDA does not approve individual food labels before food products can be marketed. But FDA regulations require nutrition and other specified information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and not misleading, and must comply with any regulatory requirements for the type of claim.
FDA regulations provide three types of claims for food and dietary supplement labels: health claims, structure/function claims, and nutrient content claims. Different requirements generally apply to each type of claim.
I conduct label review for all foods and dietary supplements in accordance with FDA regulations. I can also help submit a 30-Day Structure/Function Claim Notification to the FDA for dietary supplements.
I provide advertising counseling for foods and dietary supplements to ensure conformance with regards to third-party testimonials and websites, social media, claim substantiation (amount of scientific support) and various other FTC regulations.
The FDA requires most foreign and domestic facilities that manufacture, process, pack or store foods and dietary supplements marketed in the U.S. to register with FDA. Under the Bioterrorism Act, foreign firms must also provide prior notice of import before their products arrive in the U.S.
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a dietary supplement company whose name appears on the product label must report to the FDA certain adverse events associated with the product and maintain reports of adverse events. I help clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance.
If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to “fix” a deficiency so that you wouldn’t have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast.
FDA regulates medical devices based on their intended use and risk level. Medical devices are generally assigned to one of the three regulatory classes: Class I, Class II, and Class III. The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance or approval to market.
Most, approximately 74%, of Class I devices do not require premarket clearance or approval from the FDA.
Most of Class II and some Class I devices, on the other hand, require a 510(k) premarket notification for marketing. The submission of a 510(k) allows the FDA to determine whether the device is “substantially equivalent” to a device legally marketed in the U.S. (called a “predicate device”). A 510(k) usually requires limited or no clinical trial.
For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA’s have not been called for. In that case, a 510(k) will be the route to market. A PMA requires full reports of safety and effectiveness of the device for its intended use, and therefore generally requires clinical trials.
If you intend to market a new medical device (or an existing device for a new use), it is important to figure out early on the class(es) to which your device will be assigned so that you can start planning and preparing for the type of premarketing submission/application (if any) and regulatory requirements applicable for the device.
Sometimes a device may be assigned to multiple regulatory classes for different intended uses, and you may be able to sell the device immediately for a particular use without a 510(k). This approach can be beneficial especially for a start up company who can start generating income from a device for one intended use while preparing and applying for a 510(k) for another use.
I provide clients with product development counseling, including determining possible classification(s) and regulatory requirements for your product, to help you develop a regulatory strategy that best aligns with your business goals.
The FDA requires certain facilities that manufacture, process, pack, store or distribute medical devices marketed in the U.S. file registrations with FDA, and list their medical devices with the agency.
The Food and Drug Administration Modernization Act (FDAMA) describes certain conditions under which a medical device manufacturer could choose to disseminate medical and scientific information discussing unapproved uses of cleared or approved medical devices to healthcare professionals and certain entities. FDAMA section 401 provides that, if these conditions were met, dissemination of such journal articles or reference publications would not be considered as evidence of the manufacturer’s intent that the product be used for an unapproved new use. Further, understanding the need to attract and educate potential investors, the FDA does allow the display of investigational and unapproved devices at tradeshows, in direct mailing and on websites, but only under certain conditions.
Over-the-counter (OTC) drugs that comply with the FDA’s OTC monograph regulations do not require premarket approval. The monograph serves as a “recipe book” specifying what active ingredients and levels may be used, and for what intended uses.
In October, 2019, the FDA issued a revised draft guidance document clarifying that all homeopathic drugs are subject to premarket approval. The FDA intends to prioritize its enforcement actions against unapproved products that, among other things, have potential safety risks, lack evidence of effectiveness, are health fraud products, or are reformulated to evade an FDA enforcement action.
I conduct label review in accordance with the FDA’s OTC monograph regulations.
All drug manufacturers, processors, packers, repackers, labelers, and relabelers who offer drugs for sale or distribution in the U.S. are required to register their drug establishments with the FDA. Every drug establishment registered with the FDA must submit a list of every drug they have in commercial distribution to obtain NDC (National Drug Code) numbers.
The FDA does not approve individual cosmetics (except color additives) before they can be marketed. But under FDA regulations, cosmetics must be properly labeled and must be safe for their intended uses.
Cosmetic companies may, but are not required to, register with the FDA.
Federal law defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
A company can run into trouble when its product labeling makes claims beyond these permitted cosmetic uses. Examples include claims that a product will restore hair growth, reduce cellulite, or remove wrinkle. The differences between a cosmetic claim and an unpermitted drug claim can be subtle, and failure to appreciate the subtleties can result in enforcement actions by the FDA.
I conduct ingredient and labeling review of cosmetics as well as an analysis of any claims made on their websites to help ensure compliance with FDA regulations.