Sheldon Baker11.11.11
Rakesh Amin is a partner at the Chicago-based law firm of Amin Talati. Amin practices Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Customs, U.S. Department of Agriculture (USDA) and related regulatory and litigation matters. He regularly provides legal counsel regarding food, dietary supplement, drug, cosmetic and medical device laws, including pre/post marketing requirements, GRAS and NDI issues, OTC-drug monograph and homeopathic listings, labeling, advertising, good manufacturing practices, inspections, import detentions, warning letters, 483s and recalls. Related to his FTC practice, Amin helps companies defend consumer false advertising class actions and respond to National Advertising Division (NAD) inquiries. Mr. Amin also practices heavily in patents, trademarks, copyrights and trade secrets. His practice includes the searching, procurement, maintenance, licensing and litigation related to patents and trademarks, including counseling related to freedom-to-operate and patent invalidity opinions. He litigates IP infringement, unfair competition and breach of contract matters in federal courts throughout the country. Mr. Amin lastly helps companies draft and negotiate various types of contracts including supplier, distributor, contract manufacturing and media-related agreements. The firm’s website is www.AminTalati.com.
Health E-Insights: What is the greatest legal challenge the industry faces today?
Mr. Amin: I think the greatest legal challenge our industry faces is to make sure DSHEA is not repealed or gutted due to misguided perceptions of rampant non-compliance and the lack of effectiveness and safety data for dietary supplements. The FTC is involved here too and if it is able to accomplish its apparent goal to basically shut down or stifle truthful and non-misleading commercial free speech based on alleged substantiation requirements, then companies will have a hard time selling any product. Thus it is crucial that dietary supplement companies comply with the various regulations in good faith and the trade associations get support from the industry so they can continue to respond to the negative press. Companies need to comply with GMP regulations, including analytical testing requirements, as well as the need to label in compliance with FDA regulations and also advertise in a truthful and non-misleading manner. The FDA, FTC, state agencies and class action attorneys are going to be more aggressive in challenging companies over the next five to 10 years. I see a substantial increase in FDA inspections dealing with GMPs and labeling, an increased amount of FTC and related state AG/DA enforcement activity, as well as increased consumer false advertising/class action litigation. Thus our greatest challenge is getting companies as compliant as possible and to weed out the nasty bad players so we have a chance to endure all the challenges ahead of us.
Health E-Insights: Do you find companies hesitate to call for legal counsel or business advice?
Mr. Amin: Yes. I believe companies hesitate to call for legal counsel or business advice for several reasons including the most obvious, the money and cost of obtaining legal advice. It may be easy to infer that companies don’t like to hear what the attorneys have to say and that is why they are not seeking that advice, but I don’t think that is the real issue. Most companies want to hear the negative, devil’s advocate type of position so they are in a better position to assess risk and move their business forward knowing the risk and issues that are in front of them. However, many companies often have budgets that do not account for legal reviews or even solving legal problems. Sometimes companies decide to gain some traction and revenue before spending on attorneys for such things as FDA/FTC or IP clearance, but that is putting the cart before the horse so to speak. At the end of the day, I think not spending time and money on wrapping their heads around the legal issues will put companies at risk so that they will not be as sustainable and profitable as they could be if they just addressed the legal issues, whether it be in-house or via outside legal counsel. In other words, I think an ounce of prevention is worth a pound of cure, especially in this marketplace with all the various regulatory agencies and class action attorneys putting supplement companies under a microscope. That is why I think sound legal advice pays off in spades. If you understand the legal issues and risks and address them head on, then companies will be able to endure challenges and become not only profitable, but sustainable too.
Health E-Insights: Is the supplement industry moving in a positive direction?
Mr. Amin: I believe so. I think more and more companies are trying to become as straight as possible, mainly because I believe that they realize that being straight is going to result in sustainability and profits. I think companies are spending more time and money on compliance and that is a positive direction. More and more companies are spending time and money to endure various regulatory and class action challenges, but many companies see the challenges on the horizon and are addressing them before challenges. And it is the right way to do it. I also believe companies are supporting their trade associations more than ever, although I believe they should be doing more considering the target that our industry has on its back. I further see more consolidation occurring in our industry, which I believe is a positive sign that will lead to more compliance and a better reputation.
Health E-Insights: Besides your kids, as a law firm partner, what keeps you up at night?
Mr. Amin: I am always concerned about winning my lawsuits and providing the highest quality advice so my clients obtain the best results as possible. Doing this is not an easy task and it takes constant focus, but it pays off and can build a nice reputation if you provide quality advice and strong results on a consistent basis. We do this because our goal is for a long-term relationship and not to just help with one label review or one patent. If we focus on consistent competency and obtaining the desired results for our clients, as opposed to focusing on law firm profits, I believe our reputation will be strong and that is really all that I’m able to control. But it does keep me up at night.
Health E-Insights: What is the most unique aspect of your firm?
Mr. Amin: I believe we are the only FDA/FTC boutique law firm that has a strong patent procurement, licensing and litigation practice. Many companies in the industry associate our firm with FDA and FTC counseling only, however our firm is known in many circles based primarily on our patent expertise including conducting patent searches, getting patents issued for clients, rendering freedom-to-operate opinions and having a strong record in high-stakes patent litigation. Our firm certainly focuses on label and advertising reviews, GMPs, warning letters, recalls, GRAS and NDIs, yet we manage thousands of patents and trademarks as well—all under one roof. I think this is fairly unique outside of big law firm settings.
Health E-Insights: Who has had the biggest influence on your life?
Mr. Amin: By far my mom and dad have had the biggest influence in my life. They helped educate me and taught me to work hard, have strong character traits and be close with family and friends.
Sheldon Baker wants to interview you. Contact Sheldon at sbaker@bakerdillon.com. Follow him on Twitter @NutraInk and visit his website at www.BakerDillon.com.
Health E-Insights: What is the greatest legal challenge the industry faces today?
Mr. Amin: I think the greatest legal challenge our industry faces is to make sure DSHEA is not repealed or gutted due to misguided perceptions of rampant non-compliance and the lack of effectiveness and safety data for dietary supplements. The FTC is involved here too and if it is able to accomplish its apparent goal to basically shut down or stifle truthful and non-misleading commercial free speech based on alleged substantiation requirements, then companies will have a hard time selling any product. Thus it is crucial that dietary supplement companies comply with the various regulations in good faith and the trade associations get support from the industry so they can continue to respond to the negative press. Companies need to comply with GMP regulations, including analytical testing requirements, as well as the need to label in compliance with FDA regulations and also advertise in a truthful and non-misleading manner. The FDA, FTC, state agencies and class action attorneys are going to be more aggressive in challenging companies over the next five to 10 years. I see a substantial increase in FDA inspections dealing with GMPs and labeling, an increased amount of FTC and related state AG/DA enforcement activity, as well as increased consumer false advertising/class action litigation. Thus our greatest challenge is getting companies as compliant as possible and to weed out the nasty bad players so we have a chance to endure all the challenges ahead of us.
Health E-Insights: Do you find companies hesitate to call for legal counsel or business advice?
Mr. Amin: Yes. I believe companies hesitate to call for legal counsel or business advice for several reasons including the most obvious, the money and cost of obtaining legal advice. It may be easy to infer that companies don’t like to hear what the attorneys have to say and that is why they are not seeking that advice, but I don’t think that is the real issue. Most companies want to hear the negative, devil’s advocate type of position so they are in a better position to assess risk and move their business forward knowing the risk and issues that are in front of them. However, many companies often have budgets that do not account for legal reviews or even solving legal problems. Sometimes companies decide to gain some traction and revenue before spending on attorneys for such things as FDA/FTC or IP clearance, but that is putting the cart before the horse so to speak. At the end of the day, I think not spending time and money on wrapping their heads around the legal issues will put companies at risk so that they will not be as sustainable and profitable as they could be if they just addressed the legal issues, whether it be in-house or via outside legal counsel. In other words, I think an ounce of prevention is worth a pound of cure, especially in this marketplace with all the various regulatory agencies and class action attorneys putting supplement companies under a microscope. That is why I think sound legal advice pays off in spades. If you understand the legal issues and risks and address them head on, then companies will be able to endure challenges and become not only profitable, but sustainable too.
Health E-Insights: Is the supplement industry moving in a positive direction?
Mr. Amin: I believe so. I think more and more companies are trying to become as straight as possible, mainly because I believe that they realize that being straight is going to result in sustainability and profits. I think companies are spending more time and money on compliance and that is a positive direction. More and more companies are spending time and money to endure various regulatory and class action challenges, but many companies see the challenges on the horizon and are addressing them before challenges. And it is the right way to do it. I also believe companies are supporting their trade associations more than ever, although I believe they should be doing more considering the target that our industry has on its back. I further see more consolidation occurring in our industry, which I believe is a positive sign that will lead to more compliance and a better reputation.
Health E-Insights: Besides your kids, as a law firm partner, what keeps you up at night?
Mr. Amin: I am always concerned about winning my lawsuits and providing the highest quality advice so my clients obtain the best results as possible. Doing this is not an easy task and it takes constant focus, but it pays off and can build a nice reputation if you provide quality advice and strong results on a consistent basis. We do this because our goal is for a long-term relationship and not to just help with one label review or one patent. If we focus on consistent competency and obtaining the desired results for our clients, as opposed to focusing on law firm profits, I believe our reputation will be strong and that is really all that I’m able to control. But it does keep me up at night.
Health E-Insights: What is the most unique aspect of your firm?
Mr. Amin: I believe we are the only FDA/FTC boutique law firm that has a strong patent procurement, licensing and litigation practice. Many companies in the industry associate our firm with FDA and FTC counseling only, however our firm is known in many circles based primarily on our patent expertise including conducting patent searches, getting patents issued for clients, rendering freedom-to-operate opinions and having a strong record in high-stakes patent litigation. Our firm certainly focuses on label and advertising reviews, GMPs, warning letters, recalls, GRAS and NDIs, yet we manage thousands of patents and trademarks as well—all under one roof. I think this is fairly unique outside of big law firm settings.
Health E-Insights: Who has had the biggest influence on your life?
Mr. Amin: By far my mom and dad have had the biggest influence in my life. They helped educate me and taught me to work hard, have strong character traits and be close with family and friends.
Sheldon Baker wants to interview you. Contact Sheldon at sbaker@bakerdillon.com. Follow him on Twitter @NutraInk and visit his website at www.BakerDillon.com.
