FDA Food and Drug Investigations
J. Clark Baird 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.
J. Clark Baird 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, J. Clark Baird PLLC can help you AVOID enforcement or regulatory problems by reviewing your product labels, marketing, ingredients, or manufacturing processes.
J. Clark Baird 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.
J. Clark Baird 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-issued warning letters are usually the FDA’s first course of action against dietary supplement companies for alleged non-compliance with the FFDCA and/or FDA regulations. Per the written terms of warning letters, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. A company must respond to all violations, including those not explicitly cited in warning letters. Accordingly, it is important to determine what regulatory issues prompted the FDA’s action in order to respond fully and accurately. Finally, it must be noted that the company must not only detail how they will correct alleged deficiencies, but they must also take all steps necessary to correct these issues.
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 J. Clark Baird 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.
We can review or prepare labels and advise your company regarding products requiring FDA/FTC-compliant labeling such as dietary supplements, nutraceuticals, or cosmetics. We will assist with FDA compliance regarding foods, dietary supplements, drugs, or medical devices. We can determine whether product names and claims cause the product to meet the FDCA definition of “drugs” by making implied disease claims (versus allowed structure/function claims). We can review client’s evidence of substantiation of claims in light of federal and state substantiation requirements, and draft compliant disclaimers. In addition, we can provide legal review & advice relating to Marketing Materials (including brochures and main website) in light of FDA and FTC issues concerning claims, testimonials & endorsements.The Dietary Health Safety and Education Act of 1994 (“DSHEA”) amends the federal Food, Drug & Cosmetic Act (“FDCA”), the foundational federal law governing foods, drugs, cosmetics, and medical devices.Definition of Dietary SupplementThe DSHEA specifically defines a “dietary supplement” as:
- 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.
When a company in the dietary supplement, food or drug industry is under governmental investigation, it is crucial to have representation by lawyers who are experienced in dealing with federal regulatory agencies and the federal criminal and civil laws that apply. Supplement lawyer J. Clark Baird assists clients in resolving investigations in the early stages, as well as representing clients in administrative hearings or federal criminal or civil litigation.Our supplement law firm assists clients and their companies deal with subpoenas, investigative demands, notices of seizures, forfeitures, injunctions and lawsuits from agencies such as the FDA, FTC and State Attorney Generals. We also represent clients in civil RICO cases and Lanham Act claims.Attorney J. Clark Baird understands how your company’s reputation is invaluable. A federal criminal or civil investigation could destroy your company and your profits. Don’t wait till it’s too late to deal with a federal investigation.Our supplement law services can even assist clients in avoiding federal criminal and civil investigations from the outset. By consulting with our experienced supplement lawyers in developing proprietary formulas, drafting labeling claims and writing advertising, your dietary supplement company can avoid many of the headaches and hassles of a federal criminal or civil investigation; then you can focus on maximizing your company’s profits! It is usually more economical to invest in the front-end legal counseling than to fight a federal regulatory investigation or litigation.
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
Just as FDA enforcement focuses on labels, labeling, safety and purity issues in food products and nutritional supplements, the Federal Trade Commission (FTC) enforces advertising and marketing standards to ensure that all claims are truthful, not misleading and adequately substantiated. The supplement attorneys at J. Clark Baird PLLC advise companies involved with any aspect of the food and supplements industries concerning the best ways to respond to FTC enforcement proceedings. We also assist companies with review of advertising and Internet web sites to help avoid FTC enforcement proceedings in the first instance.There are significant differences between the FTC and FDA in their approaches to regulatory enforcement. Although FDA in recent years has lacked the resources to enforce its regulations through the use of judicial proceedings, it has used its ability to compel compliance primarily through requesting that companies engage in recalls of violative products and by issuing Warning Letters, which give companies an opportunity to address issues raised by the agency.By contrast, the FTC approach typically relies on aggressive litigation tactics that challenge advertisers’ ability to substantiate misleading claims with scientifically acceptable evidence and that involve confiscation of the related profits and decrees with injunctions that bind companies and responsible individuals for 20 years. FTC enforcement actions frequently involve compelled process forcing companies to turn over documents and other evidence and can often lead to costly litigation or administrative hearings.If the FTC suspects a violation involving product claims that appear in any advertising medium, ranging from retail displays to Web sites, its Bureau of Consumer Protection can choose to proceed against your company in a number of ways.
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 J. Clark Baird 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 J. Clark Baird today to help solve your company’s problems. Don’t wait till your company’s situation is crucial! Email us at email@example.com or call us at (502) 583-3388 or afterhours at (502) 797-4625.