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FDA Food and Drug Investigations
Nick Mudd PLLC represents businesses and individuals in FDA food and drug investigations, FDA warning letters, FDA compliance and enforcement matters, and can deal with FDA headquarters compliance offices and the regional, district, and resident field offices. We can assist you through the FDA inspection process. If you receive a warning letter, we draft responses for the client and assist them in developing and implementing corrective actions and policies. We can determine exactly what corrective measures need to be followed: recall actions, field corrections, product modifications, and supplemental labeling, as needed.
Nick Mudd can also address more complicated FDA regulatory compliance and enforcement matters, such as injunction actions and seizures, and litigation, or negotiation over consent decrees so you can continue or resume product distribution. In addition to addressing FDA compliance emergencies when they arise, Nick Mudd PLLC can help you AVOID enforcement or regulatory problems by reviewing your product labels, marketing, ingredients, or manufacturing processes.
Nick Mudd PLLC has represented clients in regards to issues with GMP (good manufacturing process), Dietary Health Supplement Enforcement Act (DHSEA), Federal Food, Drug and Cosmetic Act (FFDCA), Designer Anabolic Steroid Act, exportation and importation laws.
Nick Mudd has represented clients who manufacture, distribute, or sell food products, dietary supplements, drugs, and cosmetics. If your lawyer doesn t understand the difference between a supplement and a drug, you should call us TODAY!!!
FDA Enforcement and Warning Letters
While warning letters are considered an informal mechanism of FDA action, the failure to respond appropriately may often result in more formal enforcement actions being taken against non-compliant dietary supplement companies. Because the response to the warning letter is often the company’s only chance at avoiding more costly administrative hearings or civil or criminal litigation, then it is absolutely vital to provide a comprehensive answer to the alleged deficiencies. Therefore our FDA regulatory lawyer can allow you to develop responses to warning letters that can help you avoid further FDA enforcement.
Responses to Warning Letters
At Nick Mudd PLLC, a FDA regulatory lawyer can help you respond to FDA warning letters by:
- Reviewing the legal and regulatory basis for your warning letters;
- Determining the appropriate measures that need to be taken in order to reestablish compliance with federal laws and/or FDA regulations;
- Drafting and preparing a response to warning letters, within the time-frame necessary;
- Communicating with the FDA on your behalf with respect to the warning letters and your regulatory commitments, and
- Helping you ultimately achieve compliance by providing guidance as to the necessary corrective measures.
- a product taken by mouth
- that is “intended to supplement the diet”
- and that contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet by increasing total dietary intake;
- or, a concentrate, metabolite, constituent, extract, or combination of any ingredient intended above;
- further, the product must be labeled as a dietary supplement, and,
- must not be represented for use as a conventional food or as the sole item of a meal or the diet. (Note: this part of the definition does not mean that we are only talking about weight loss or dietary products.)
The key regulatory impact of the DSHEA is that a product that meets the definition of a “dietary supplement” does not need FDA approval of safety and effectiveness before being marketed. Our supplement law firm guides clients in various FDA regulatory areas:
- dietary supplements
- foods and food additives
- over the counter drugs
Often products are a mixture of two or more of these categories, which make it all the more essential to have an experienced FDA regulatory lawyer.
The areas and types of issues we solve for our clients include:
- FTC, Section 5 Truthful Advertising claims – civil investigative demands and complaints
- FDA, USDA, State AG and Departments of Health Regulatory Actions, including answering warning letters.
- Defending against product import detentions, seizures, recalls, injunctions and criminal proceedings and other issues involving the Department of Homeland Security (U.S. Customs)
- CPSC investigations into whether companies are in compliance with the reporting requirements of Section 15(b) of the Consumer Product Safety Act.
- Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act of 1986)
- DEA enforcement proceedings involving product and asset seizures, prosecutions of DEA licenses, and other DEA regulatory proceedings
- Federal and state criminal charges
- Federal civil RICO claims
- Federal Lanham Act and unfair competition claims
MISBRANDED & MISLABELED DRUGS
The FDA has increased it s criminal enforcement side. The primary criminal charges that are brought by FDA investigations are the introduction into interstate commerce of misbranded or mislabeled drugs. Misbranding occurs when a product’s label is incomplete, false, or misleading. A product’s label includes any written, printed, or graphic matter that appears on the product or its container. It also includes information that accompanies the product, such as advertisements for the product. However, not everything that mentions the product constitutes labeling. Information that is considered a part of a product’s label tends to be information that supplements or explains the product.
The following are examples of misbranding:
- A label that does not contain adequate directions for use or necessary warnings.
- A label that does not contain precautionary statements about preventing deterioration of the product.
- A label that fails to prominently display required information.
- A label that includes instructions related to dosage or frequency or manner of use that if followed would be dangerous to the user’s health.
There are several things to keep in mind concerning misbranding. For example, it is equally important to examine what is written as well as what is not written in a product’s labeling. Affirmative representations and material omissions can result in a misbranding allegation.
Further, whether or not there was intent to misbrand a product does not matter. The fact that the product was misbranded is enough. Lack of intent, conscious or otherwise, while perhaps a mitigating factor, is not a sufficient defense against a misbranding allegation.
Lastly, misbranding can occur even if there is only one misstatement within numerous valid statements. Consequently, you should examine each statement on a product’s label to determine whether it is complete, unambiguous, and true. When doing so, consider what each statement would mean to an average, reasonable user.
- F.B.I. Federal Misbranded Drug Cases
- National Association of Criminal Defense Attorneys: Defending A Misbranded Drug Case
- F.D.A. Key Federal Legal Concepts: Interstate Commerce, Adulterated, and Misbranded Drugs
FTC Access Letters, Civil Investigation Demands and Federal Litigation
If you receive a so-called “access letter,” you will have the opportunity to produce documentation that substantiates your product claims and explains how your advertising and marketing materials are truthful and not misleading. Be prepared to defend implied claims, or product performance characteristics that are not explicitly stated.
If your company fails to respond to an access letter, the FTC will probably issue a Civil Investigative Demand, which amounts to an order that your company produce a great deal of data ranging from clinical test results to detailed financial information. The spirit of this review is likely to be significantly more adversarial than proceedings under an access letter.
There is no guarantee that the FTC will choose the access letter as its first step. It might proceed immediately to injunctive relief to freeze your company’s assets until it can calculate the amount of “consumer redress” necessary to remedy violations. Or the FTC can sue both your company and responsible individuals in federal court to establish liability and prove damages.
Experienced FTC Enforcement Defense Attorneys
The FTC defense lawyers at Nick Mudd PLLC have extensive experience advising manufacturers, marketers and distributors nationwide about regulatory compliance and enforcement in the dietary and nutritional supplements industry.
Whether we defend you on the merits of an FTC complaint or negotiate a settlement depends on the specific facts of your case and your exposure to loss. Contact FTC regulatory lawyer Nick Mudd today to help solve your company’s problems. Don’t wait till your company’s situation is crucial! Email us at Nick@MuddLegalGroup.com or call us at (502) 536-8062 or afterhours at (502) 536-8062.