Source: http://www.emord.com/frequently-asked-questions.html
Timestamp: 2017-03-26 16:58:53
Document Index: 258973913

Matched Legal Cases: ['§ 350', '§10', '§ 331', 'in fine', '§ 331', '§ 1125']

Emord & Associates is dedicated to serving the needs of its national client base. The firm’s attorneys represent clients in constitutional and administrative law cases before the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ), the Department of the Interior, the Bureau of Land Management (BLM), the National Park Service (NPS), the Equal Employment Opportunity Commission, the Environmental Protection Agency (EPA), and the Federal Communications Commission (FCC). FDA | USDA | Import | Export | FTC | Advertising | Compliance | Dietary Supplements | Foods | Labeling | Prescription & OTC Drugs | Cosmetics | Animal Feeds & Supplements | DEA | Controlled Substances | Medicare | Licensing | Commercial Litigation | Contracts | Business | Civil Litigation | Constitutional LawCopyright © 2010 Emord & Associates, P.C. All rights reserved | Sitemap Front PageFirm ProfilePeoplePractice AreasBlogLegal EventsMediaContactFood, Drug, and Cosmetic Law FAQS
Q: Will I need to submit a new dietary ingredient notification for my products that have already been marketed?
A: The FDA updated its policies concerning New Dietary Ingredient (NDI) 75-day premarket notifications in July 2011. It is now more difficult than ever to establish grandfathered status of a dietary ingredient. Because the FDA greatly expanded the reach of the NDI statute (21 U.S.C. § 350b), many products on the market will be subject to the NDI notification requirements in Section 350b. 75-day notifications require evidence of a history of safe use in the United States food supply. In general, the more proprietary an ingredient, the more likely FDA will require safety testing to support a NDI notification. If a product contains a “new dietary ingredient” subject to the notification requirements, the dietary supplement cannot be marketed with that ingredient without first proceeding through the 75-day premarket notification process. FDA may deem a dietary supplement adulterated if not in compliance with the NDI statute or regulations. Please do not hesitate to contact Emord & Associates with any questions concerning the FDA’s New Dietary Ingredient (NDI) policies or regulations. ^ Top | Contact Us
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. ^ Top | Contact Us
Q: Will I always receive a Warning from FDA before the agency takes enforcement action?
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, §10-2. Nonetheless, FDA often adopts a policy of prior notice in the form of Warning Letters. The failure to take prompt and significant corrective measures invariably leads to FDA enforcement. We thus recommend that companies become aware of their exposure before receiving a Warning Letter. Under 21 U.S.C. § 331, there exist over 30 different violations chargeable. Each charge may lead to significant consequences. FDA often requests significant changes in labeling and manufacturing in their Warning Letters. If your products or business is not in compliance with federal food and drug regulations, it is best not to wait until you receive a Warning Letter to find out. Emord & Associates FDA attorneys regularly perform labels reviews, cGMP compliance reviews, mock inspections, and product claims reviews. ^ Top | Contact Us
Q: Will the FDA inspect my company?
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. ^ Top | Contact Us
Q: What should we do when the FDA arrives for an 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.
Q: The FDA says my product is adulterated and/or misbranded. What sort of consequences am I facing?
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.
Q: How can I be certain that my business is in compliance with the new dietary supplement cGMP regulations?
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. ^ Top | Contact Us
Q: We have another company manufacture and ship our private label products directly to consumers. Are we covered by the FDA’s new cGMP regulations?
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.
Q: Should I have my product labels reviewed before I market my product?
A: FDA does not pre-approve product labels, but labeling violations can lead to FDA enforcement action. FDA recently issued warning letters to 17 food manufacturers for labeling violations. See “FDA Calls for Corrections to ‘Food Labeling Violations” (March 3, 2010). While not every product label will need expert review, many of our clients desire the confidence that their labels can pass before an expert eye. Emord & Associates regularly performs label reviews for foods, OTC drugs, homeopathic products, and dietary supplements. Our attorneys give detailed advice and explanations so that our clients are educated on how best to comply with the law. We provide advanced estimates and prompt service. ^ Top | Contact Us
Q: What sort of advertising claims can I make about my dietary supplement?
A: The FDA permits several categories of product claims for dietary supplement products. Some claims require FDA pre-approval, others require advanced pre-market notification. FDA will examine your claims to determine compliance with federal law. Certain claims may render your product an unapproved new drug under the Food, Drug, and Cosmetic Act. In addition, the FDA may impute certain claims to your product through labeling, trade dress, and even consumer impression. Charges based on “unapproved new drugs” are of the most frequent enforcement actions filed by the FDA. Companies should be certain that their claim language is lawful under FDA and FTC regulations, and that their claims are backed by evidence sufficient to meet the legal burdens. Our FDA and FTC attorneys are very experienced in labeling and advertising review. Emord and Associates has filed more successful health claim petitions with the FDA than any other, and has defeated FDA six times in federal court when the agency has denied qualified claims for dietary supplements. From long experience and a detailed understanding of the regulatory and constitutional issues involved, our FDA and FTC attorneys can help clients overcome barriers to the dissemination of truthful health information and protect their interests. ^ Top | Contact Us
Q: Will the FDA look at my website?
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. ^ Top | Contact Us
Q: Must the FDA preapprove the ingredients in my dietary supplement?
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. ^ Top | Contact Us
Q: How can I tell if my product contains a New Dietary Ingredient (NDI)?
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-components and chemical compounds as “new” under the Dietary Supplement Health and Education Act (DSHEA). Contact Emord & Associates if you need assistance determining whether your ingredients are lawful for sale in the United States. Our FDA lawyers can properly classify your ingredients and help bring your product safely to market.
Q: What does “GRAS” stand for, and when do I need to be concerned about it?
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. ^ Top | Contact Us
Q: How can we petition FDA for a health claim?
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.
Q: If my dietary supplement is lawful for sale in the United States, can I sell it in Europe as well?
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-objectionable in the EU, the legal path to market must be satisfied independently in both the EU and US markets. For instance, approved labeling and claim language can differ between the two jurisdictions. The attorneys at Emord & Associates have experience working with the EFSA and counseling clients on issues of EU food and drug law. ^ Top | Contact Us
Q: How do I know if my product is regulated under California’s Proposition 65? How do I know if my consumer warning complies?
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.
Q: Does FDA regulate pet food supplements differently from human dietary supplements?
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. ^ Top | Contact Us
Q: Do I need FDA preapproval of my Cosmetic or topical product?
A: Although FDA does not generally require pre-approval for certain cosmetic products, cosmetic companies marketing topical products should avoid marketing cosmetic drugs, or “cosmeceuticals.” Whether a product is lawfully marketed often depends on the nature of the ingredients and the intended use for the product. Emord & Associates’ FDA attorneys can work with companies to determine the proper product classification. Our lawyers can review your product for FDA compliance and, if necessary, help bring the product through the FDA approval process. If you have questions concerning your cosmetic product, contact one of our attorneys for a free consultation.
Q: A competitor misrepresents its products, do you have any legal rights against them?
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. ^ Top | Contact Us
Q: What is the Lanham Act?
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. ^ Top | Contact Us
Q: Can a business be sued in a private action for false advertising?
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. ^ Top | Contact Us
Q; What damages are recoverable in a Lanham Act false advertising suit?
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.
Q: Your company has been sued for false advertising, how much does it cost to defend the lawsuit?
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.
Q: One of your competitors threatened you with a false advertising or unfair competition lawsuit, do you need counsel to respond?
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. ^ Top | Contact Us
Q: What is the NAD and how does it regulate advertising?
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-house counsel, marketing executives, research and development departments and outside consultants in the review of claim substantiation and competitor challenges. NAD review is permitted only for national advertisements. More information is available on NAD's website or by contacting any of the advertising attorneys at Emord & Associates.
Q: You have been subpoenaed for a deposition, do you need counsel?
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.
Q: What types of litigation does Emord & Associates handle?
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.
Q: How can you find an expert witness for your ongoing case?
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-client relationship is created by this communication. The information provided herein is for informational and educational purposes only.
Unfair Competition & False Advertising Law FAQs
Q: Can a business be sued is a private action for false advertising?
Q: What damages are recoverable in a Lanham Act false advertising suit?
General Civil Litigation FAQs
Q: You have been subpoenaed for deposition, do you need counsel?