Food, Drug, and Cosmetic Law FAQS
A: The FDA updated its policies concerning New Dietary Ingredient (NDI) 75-
Q: I just received a Warning Letter from the FDA, do I need an attorney?
A: FDA Warning Letters often precede enforcement action. Although styled as a “warning,” an FDA warning letter reveals that the company in question is under close FDA scrutiny and is suspected of agency rule violations. At a minimum, the receipt of a Warning Letter places your company in a high risk pool. Many companies that downplay the significance of a Warning Letter may find that further FDA action is inevitable. Warning letters should be responded to promptly and thoroughly. FDA regularly provides just 15 days for a response. Moreover, because a Warning Letter is often the first stage in a civil or administrative enforcement action, good legal counsel can prevent significant missteps at the outset. If you question whether your company needs the assistance of legal counsel, we encourage you to contact the FDA lawyers at Emord & Associates, P.C. The firm never charges to determine whether it is appropriately suited to represent you in a matter, and you will speak directly with an attorney.
A: The FDA is not obliged to issue Warning Letters to companies that violate provisions of the Food, Drug, and Cosmetic Act. See FDA Regulatory Procedures Manual, §10-
A: FDA’s authority overlaps with the FTC’s authority over dietary supplement advertisements and labeling. The FDA has exclusive jurisdiction over ingredients and manufacturing practices. If you own a dietary supplement company, chances are sooner or later you will have an FDA compliance inspection. The Obama Administration increased the FDA’s Food Safety budget by 30 percent for the 2011 budget. The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) performed 6,788 inspections in 2008, and that number will rise with FDA’s significantly increased budget. Following full implementation of the new dietary supplement cGMP regulations, the FDA intends to perform at least one cGMP inspection of all eligible companies.
If handled improperly, inspections can lead to FDA enforcement. In 2008, the FDA obtained 369 criminal convictions for violations of the FDCA and collected over $846 million in fines and restitution. See FDA Enforcement Story, Statistics. The agency has consistently sought criminal penalties for unlawfully marketed dietary supplements. In a recent letter to Senator Chuck Grassley, the FDA stated that it would be increasing its use of misdemeanor prosecutions, citing its belief that FDA need not prove intent to defraud when seeking criminal sanctions. The FDA’s Office of Criminal Investigations’ budget “increased a huge 73 percent from 1999 to 2008 to $41 million and also experienced a 40 percent increase in staffing.” Id. The FDA acts consistently against dietary supplement products. Since 2001, the FDA has issued at least 260 Warning Letters to offending companies. See, e.g., FDA Warning Letters for Dietary Supplements. FDA Warning Letters have increased in recent years and will likely continue to rise. See 2009 review: FDA warning letters clampdown (Jan 6, 2010) (noting that FDA warning letters increased by 65% from 2008, from 44 to 73).
Contact one of our food and drug lawyers to discuss how your company can best prepare for an FDA inspection.
A: You should plan for FDA inspections well in advance. Proper planning requires an understanding of your legal rights and the limitations on FDA’s authority. Certain legal objections must be stated at the time of the inspection or you may inadvertently waive them in subsequent proceedings. Problems can arise quickly during the actual inspection and, so, we recommend having legal counsel available if needed. We hope that government inspections never threaten your business. But when they do, our clients find confidence in their preparation and knowledge. We have offices in the East and the West, enabling our attorneys to visit most locales when inspections are underway within a matter of hours. Our FDA attorneys have considerable experience in representing company officials during FDA inspections.
A: The Federal Food, Drug and Cosmetic Act prohibits adulteration or misbranding of any drug or device. See 21 U.S.C. § 331(a) and (c). The FDCA prohibits specific acts including the introduction or delivery for introduction into interstate commerce of any drug or device that is adulterated or misbranded; the adulteration or misbranding of any drug or device in interstate commerce; the receipt in interstate commerce of any drug or device that is adulterated or misbranded, and the delivery or proffered delivery of such drug for pay or otherwise; and the introduction or delivery for introduction into interstate commerce of any article in violation of the provisions requiring approval of new drugs or devices.
Violations of the FDCA may lead to civil fines, injunctions, seizures, and criminal liability. The penalties imposed vary based on myriad factors. Every charge should be taken seriously because subsequent violations can incur heightened penalties. If the FDA has accused your company of an adulteration or misbranding violation, contact one of our attorneys and learn how our firm can assist you.
A: FDA’s new dietary supplement Current Good Manufacturing Practices (cGMPs) regulate dietary supplement companies at all stages of production. The regulations are comprehensive. The FDA admits that the regulations will impose the greatest economic burden on very small (20 or fewer employees) and small (500 or fewer employees) dietary supplement companies. Our FDA lawyers frequently provide guidance on the cGMP regulations and the firm performs mock cGMP inspections. Whether you have a simple question or a complex compliance agenda, we can help you navigate the new cGMP laws.
A: Companies are subject to the new cGMP regulations if they manufacture, package, label, or hold a dietary supplement, including a dietary supplement you manufacture but that is packaged or labeled by another person. See 21 CFR 111.1(a). Retail establishments and warehouses for retailers that sell directly to individual consumers may be excluded. Nonetheless, different sections of the regulations may apply to your organization depending on which specific aspects of production you handle. If you question whether or to what extent the new regulations apply to you, our FDA attorneys can answer your questions.
A: FDA does not pre-
A: The FDA permits several categories of product claims for dietary supplement products. Some claims require FDA pre-
A: Yes. The FDA routinely examines websites and accompanying promotional materials. In addition, when determining whether a product is used for an intended purpose, the FDA may examine information that is related to product that might place the product in a certain context. For example, the FDA may look to consumer impressions when judging whether a product is intended for sale as a drug or supplement. When preparing a product for market, therefore, we recommend having expert advice concerning claims made on labels, websites, advertising, and accompanying materials.
A: Maybe. Whether your ingredients must pass FDA approval will depend on a number of factors including, among others, the type of product, the specific nature of your ingredient, the history of the ingredient in the United States market, and the recent history of the ingredient in clinical trials. Some ingredients are “grandfathered” under the Dietary Supplement Health and Education Act (DSHEA). Companies looking to add dietary supplements to their product lines should consider consulting expert advice concerning their specific ingredients. Our FDA lawyers can assist companies from the early stages of concept development through the retail stage.
A: If FDA determines that your product contains a New Dietary Ingredient (NDI), you may be prohibited from selling your dietary supplement unless you follow specific procedures. Recent FDA precedent has increased FDA’s ability to classify common food sub-
A: “GRAS,” or “generally recognized as safe,” is a standard that must be shown for certain substances before they are intentionally added to food. GRAS status requires that qualified experts generally recognize the substance to be safe under the conditions of its intended use. If you question whether your product requires a GRAS determination or is exempt from the GRAS regulations, our FDA attorneys can explain the legal framework and provide detailed instruction.
A: Emord & Associates has successfully pursued FDA health claims and FDA “qualified” health claims before the agency and in federal court. Through a series of landmark legal victories over the FDA, our firm established the legal platform for qualified health claims under the First Amendment’s commercial speech doctrine. See Emord & Associates’ Significant Cases. Health claims generally require a detailed petition accompanied with substantial scientific support. Our FDA lawyers are best equipped to determine the level of support needed and the proper approach before the agency. If you have questions concerning the process to an FDA health claim, contact us for a free consultation.
A: Not necessarily. New laws in the EU have harmonized the dietary supplement laws and regulations, many of which are now enforced by the European Food Safety Authority (EFSA). While the EU and FDA regulations often mirror similar concepts, the path to product approval can differ. Thus, while your product may be non-
A: California’s Proposition 65 imposes a duty to warn consumers if a product contains ingredients known by the State of California to cause cancer or birth defects. Companies may reference the updated list of chemicals published by the State of California. Emord & Associates frequently analyzes product ingredients to determine whether they appear in amounts that would constitute an exposure under Prop 65 regulations. In addition, our food and drug lawyers can assess whether warning systems and notifications are adequate to meet the standards imposed by Prop 65 and related case law.
A: Yes. Dietary supplements permitted for sale to humans are not necessarily lawful for sale to animals. The Dietary Supplement Health and Safety Act (DSHEA) has not been extended to include animal supplements and, therefore, FDA will analyze such products under the animal food additive regulations. Emord & Associates conducts compliance reviews and analyzes animal pet supplement products. Our lawyers work with companies seeking to successfully market animal supplement or drug products.
A: Although FDA does not generally require pre-
A: Yes. Federal and State laws provide recourse to businesses wronged through unfair competition or false advertising. Remedies can be broad, providing for the recovery of a competitor’s profits, your damages or competitive loss, and injunctive relief. Whether to pursue legal action can be a complex analysis that should be explored with the help of counsel. Experienced counsel can identify the costs, likelihood of success, and alternative options.
A: The Lanham Act (title 15, chapter 22 of the U.S. Code) generally encompasses the federal laws governing trademarks and false advertising. In advertising law, the Lanham Act is a powerful tool against false or misleading advertising. False advertising claims under Section 43(a)(1)(B) of the Lanham make imposes civil liability for the use of a false or misleading description or representation of fact, which "in commercial advertising or promotion, misrepresents the nature, characteristics, qualities or geographic origin of his or her ... goods, services, or commercial activities..." 15 U.S.C. § 1125(a)(1)(B). There are several types of false or misleading advertisements. A business may harm a competitor by disparaging advertisements claiming that the competitors' products are inadequate, deficient, or otherwise inferior. A business may compare its products to a competitors' products in a way that misleads. A business may falsely promote its own products such that competitors suffer a competitive disadvantage. All such deceptive claims are actionable under the Lanham Act. To establish a Lanham Act case, a plaintiff must establish: (1) a defendant's use of advertising in or promotion in connection with goods, services, or commercial activities; (2) the use of advertising or promotion in interstate or foreign commerce; and (3) falsity of the defendant's description or representation of fact in connection with the goods or services (literal falsity or misleading in context). Claims of literally false advertising are often easier to bring in litigation because the plaintiff often need not show that consumers were deceived by the false advertisement; deception is presumed. The advertising lawyers at Emord & Associates have extensive experience in Lanham Act litigation. All consultations are free.
A: Yes. Sound advertising is crucial to the promotion of business interests. False advertising or misleading advertising, however, is unlawful and may subject businesses to civil liability. Under federal law, to establish a prima facie case for false advertising a plaintiff must show: (1) the defendant has made false or misleading statements as to his own product or the product of another; (2) there is actual deception or at least a tendency to deceive a substantial portion of the intended audience; (3) the deception is material in that it is likely to influence purchasing decisions; (4) the advertised goods traveled in interstate commerce; and (5) there is a likelihood of injury and/or a loss of goodwill. See, e.g., Novell, Inc. v. Network Trade Center, Inc., 25 F.Supp. 2d 1218 (D. Utah 1997). In addition, most states have laws that prohibit unfair competition and false advertising. State laws may encompass a broader range of business conduct. Whether a business would be liable for false advertising or unfair competition is a complex analysis. The advertising attorneys at Emord & Associates have experience reviewing ad copy and assessing risk under applicable laws.
A: The Lanham Act general provides for: compensatory damages; enhanced damages for willful or intentional conduct; attorney's fees; injunctive relief; enforcement (injunctive) relief; or preliminary injunctive relief. In many cases it may be difficult to show that a business was competitively harmed by false advertisements. General damages may include: (1) profits lost from sales actually diverted from the plaintiff to the defendant because of the false or misleading statement or representation; (2) profits lost from teh sales of products for a reduced price, if the reduction was made because of the false or misleading statement or representation; (3) the costs incurred in undertaking any corrective or responsive advertising or marketing; and (4) any other quantifiable damage to the plaintiff's good will that has not been repaired by corrective marketing. Where a defendant acts with bad faith, a plaintiff may recover its competitors' profits that were gained through deceptive means. Given the stakes, any company facing a potential claim for false advertising should consult with experienced counsel. The attorneys at Emord & Associates are experienced in false advertising and unfair competition suits.
A: In general, litigation can be expensive. Armed with that knowledge, plaintiffs may rely on cost as a basis to win uncontested judgments. However, the protection of a performing business asset and the preservation of future income may be worth defending. The cost of a defense is specific to the facts of each case. If you have questions concerning your decision to zealously defend your rights in court, contact the attorneys at Emord & Associates. Consultations are always free.
A: Probably yes. Often businesses will threaten litigation only after seeking advice of their counsel. Your immediate response could determine whether legal action follows. Once a claim is filed against you, courts often allow just twenty days for a formal response. It is generally best to have experienced counsel involved long before a complaint is filed in state or federal court. Early retention of counsel will substantially improve your position prior to and immediately after a lawsuit begins.
A: The National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) is a private arbiter that handles advertising disputes between competitors. The NAD offers a less expensive approach than litigation. NAD issues written decisions expeditiously, within 60 business days. The NAD works closely with in-
A: Yes. Although not a party to litigation, deponents give statements under oath as if they were before the court. You are required to answer all questions at a deposition that could result in relevant information, which means the scope is usually broad. If you have interests to protect that are related to the litigation, counsel could help identify your risks and, if necessary, represent you during the deposition. Contact the lawyers at Emord & Associates for a free consultation.
A: Emord & Associates has extensive experience in federal administrative, constitutional law, and commercial litigation. Emord's lawyers litigate matters concerning unfair competition, corporate law, false advertising, contracts disputes, defamation, and many other state and federal proceedings. The firm's lawyers frequently handle matters involving health products, including dietary supplements, dietary ingredients, foods, drugs, cosmetics, medical devices, and cosmetics. The firm's attorneys also serve as litigation consultants.
A: The right expert can make your case. Complex unfair competition, administrative, or commercial claims often involve nuanced or esoteric scientific issues. As part of its food, drug, and advertising law practice, the lawyers at Emord & Associates have experience locating, vetting, and preparing expert witnesses for depositions and trial. The firm maintains an extensive network of experts and can help develop a strategy for use of expert reports and testimony.
DISCLAIMER: The responses given below are not legal advice. Before undertaking any course of action in reliance on the legal information imparted, you should seek the advice of competent legal counsel. Only after a thorough evaluation of the facts applicable in an individual case can an attorney competent in the field provide legal advice upon which you may rely in confidence. Each situation is fact specific, and it is impossible to evaluate a legal problem without a comprehensive consultation and review of all the facts and documents at issue. No attorney-
Unfair Competition & False Advertising Law FAQs
General Civil Litigation FAQs