The Food and Drug Administration (FDA) can be very aggressive in terms of what they define as a medication or a medical device. At the Law Offices of John D. Kirby, A.P.C., we frequently represent businesses that have been attacked by the FDA. These businesses may face drug charges for allegedly manufacturing and distributing products that meet the FDA's definition of medications or medical devices without first getting FDA approval. The products involved in these cases are typically supplements or devices like rife frequency generators.
When you retain our law firm to defend you or your business in an FDA investigation or against a drug charge, you will get personal attention from a lawyer with more than 20 years of experience in the field of criminal law. Your case will be handled by John D. Kirby, a Cornell Law School educated lawyer and former federal criminal prosecutor.
How Was the Product Marketed?
The marketing of a product can play a role in the case. If a business markets a device with claims that it can cure disease, the FDA is likely to consider it a medical device. The FDA will prosecute businesses that sell medical devices without first getting FDA approval.
A Fine Line Between Legal and Illegal
The supplement industry is booming. Diet supplements and other supplements are big business throughout California. The businesses involved take great care to stay on the right side of FDA regulations. Unfortunately, the line between legal and illegal can be a thin one. Many ingredients in supplements are similar to ingredients that are banned by the FDA. While using the similar ingredient is legal, any use of banned products is not. If the FDA believes the line has been crossed, action will be taken. We defend supplement manufacturers against FDA actions. If you have received an FDA warning letter, we encourage you to retain our services as soon as possible so we can help you protect your business.
Free Consultation With a San Diego FDA Regulation Attorney
To schedule a free consultation with an experienced San Diego FDA attorney, call us at 619-272-6564 or contact us via e-mail.