FOOD & DIETARY
Services Include: Label reviews, Nutrition Facts Panels, Supplement Facts Panels, GMP compliance, Food Safety Plans, HACCP, structure-function claims, annual registration, Acidified Foods Registration, FDA Inspections, warning letter response, 483 response, Facility audits, Foreign Supplier Verification Program compliance & Food Contact Notifications
Bustos Law Group offers a full suite of legal regulatory services relating to food compliance. According to the Food, Drug and Cosmetic Act (FD & C Act), food is defined as, “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.” Dietary Supplements are also included as a subcategory of food. Dietary supplements are regulated similarly to food and should be treated in a similar way. If you feel your product may fit this definition, contact us and see how we can assist.
OTC & PHARMACEUTICAL
Services Include: Label reviews, Drug Facts Panel creation, warning letter responses, 483 responses, cGMP compliance, facility audits, registration, & listing
Bustos Law Group offers a full suite of legal regulatory services relating to drug compliance. Drugs are very heavily regulated by the FDA to ensure safety for consumers. According to the Food, Drug and Cosmetic Act (FD & C Act), drugs are defined as, “”articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” If you feel your product may fit this definition, contact us and see how we can assist.
Services Include: Classification, 510k/ Premarket Clearance, Premarket Approval, De Novo, Label Reviews, Marketing Reviews, GUDID, UDI, Quality System Regulation
compliance, facility audits, registration & listing
Bustos Law Group offers a full suite of legal and FDA consulting compliance services relating to medical device compliance. Medical devices are defined by the Food, Drug and Cosmetic Act as, “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory … intended for use in the diagnosis of disease or other conditions . . . or intended to affect the structure or any function of the body.” Medical Devices are regulated by class. These classes range from Class I to Class III which is the most highly regulated. Medical device compliance is vital before heading to market.
Services Include: Label reviews, ingredient reviews, cGMP compliance, product recalls, warning letters, 483 responses, import alert, color additives, marketing reviews, facility audits, FDA inspections, Voluntary Cosmetic Registration Program, FDA Cosmetic Product Ingredient Statements (CPIS) filing, cosmetic safety substantiation
Bustos Law Group offers a full suite of legal regulatory services relating to cosmetic compliance. Although, cosmetics are not subject to FDA approval, they are subject to FDA regulation. According to the Food, Drug and Cosmetic Act (FD & C Act), cosmetics are defined 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.” If you feel your product may fit this definition, contact us and see how we can assist.
IMPORT & CUSTOMS
Services Include: FSVP compliance,
Import Alerts, Warning Letters, Reconditioning, Notice of Action response, customs release.
Importing FDA regulated products into the United States is heavily regulated by the Food and Drug Administration as well as Custom and Border Patrol. These two agencies work hand in hand to ensure that the nation’s consumers are kept safe. The handling of these matters is very specialized and should be handled by professionals who specialize in the area or import and customs. If you plan to import FDA regulated products or have come across an issue during the process, call us for assistance.