Sheldon Baker07.01.12
Steven Shapiro is a partner in the New York City-based law firm of Ullman, Shapiro & Ullman, LLP. Mr. Shapiro has over 24 years of experience in food and drug regulatory matters and counsels clients in the areas of food and drug law relating to the manufacture and marketing of foods, beverages, dietary supplements, drugs, and cosmetics. Mr. Shapiro also assists clients in matters relating to enforcement by the Food and Drug Administration, including the handling of FDA inspections and the Federal Trade Commission relating to advertising enforcement matters. He is a contributor to many industry trade magazines and a frequent lecturer on topics of concern to the natural products and drug industries. Mr. Shapiro is a member of the New York and New Jersey State Bars. He is a 1986 graduate of the Syracuse University College of Law, where he was an editor of theSyracuse Law Review.
Health E-Insights: What pending legislation could impact the industry?
Mr. Shapiro: There does not seem to be any legislation affecting the industry that is likely to pass this session. But that does not mean that the industry can just sit back and relax. Other industries make their presence felt in Congress with far more lobbying than the dietary supplement industry ever does. In this country, for regulated industries, lobbying is the name of the game. Recently, Senator Richard Durbin was able to schedule a surprise amendment to a pending, must-pass FDA User Fee Act, which would have required dietary supplement facility registration and listing of all products and their ingredients with FDA. Prompt mobilization by industry with calls to Senators on a day's notice killed that amendment. Such vigilance must, however, be never ending and not just simply in response to a potential crisis. Regular interaction with Congress is essential, particularly as our industry champions leave Congress and fewer and fewer members were there for the passage of DSHEA.
Health E-Insights: Are there other industry concerns besides legislation?
Mr. Shapiro: My concern is that FDA is biding its time and very patiently undercutting aspects of DSHEA without taking the time to involve Congress by issuing draft guidances that contradict DSHEA and "chill" innovation. In addition to the well discussed concern about the draft new dietary ingredient guidance, Senator Durbin's recent letter to FDA demanding that the agency enforce its 2009 Draft Guidance affecting liquid dietary supplements and beverages continues to remain a concern. Under DSHEA, a dietary supplement could physically resemble a conventional food so long as it was not represented as a conventional food by being called a "drink" or a "cookie." Senator Durbin and FDA, apparently out of some concern over liquid energy supplements, are seeking to "re-write" DSHEA without bothering to go through Congress. The draft guidance would be a substantive change in the Agency’s statutory and regulatory policy toward how it distinguishes dietary supplements from conventional foods and beverages. For the first time, in contradiction to 18 years of policy and public statements, FDA has used a draft guidance to announce that a product's physical form and packaging, together with the volume of liquid consumed will be determinative factors in whether a product will be regulated as a dietary supplement of a conventional beverage.” Thus, ingredients in such products would be subject to "food additive" status and a safety standard, which the FDA must perceive as less onerous that the "significant or unreasonable" safety standard that applies to dietary supplement ingredients. Moreover, FDA can extend its analysis right down the slippery slope to such things as "bar" dietary supplements that are packaged similarly to candy bars, powder dietary supplements that are packaged similarly to breakfast drinks or "gummy" vitamins that look like candy. There is a reason that packaging has not been a factor in making this determination and FDA should not finalize a guidance that would make it a determinative factor now.
Health E-Insights: What do you consider is the biggest legal hurdle supplement companies face?
Mr. Shapiro: Without question, the biggest legal hurdle for the dietary supplement industry going forward is going to be compliance with the FDA's Good Manufacturing Practice (GMP) regulations. I view these regulations as taking the industry from childhood into adulthood. Obviously, for the industry to grow and prosper, consumers must be confident that products are properly labeled and contain exactly what the label says that they contain. As raised by Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, at the American Herbal Products Association's recent Botanical Congress in New York, it is frightening that during inspections FDA is finding that such a large percentage of companies are failing to have implemented or comply with even the most basic requirements of the new GMPs. Clearly, FDA is taking its obligation to ensure compliance seriously and appears to be taking prompt action against companies that are failing to meet their obligations. According to Dr. Fabricant we should expect to see more inspections, more injunctions, and more product seizures related to failure of companies to comply with the basic GMP requirements.
Health E-Insights: What are the most important decisions you make as a partner of your firm?
Mr. Shapiro: I provide legal services to an industry that I care deeply about, but am also running a business. Many of our clients market dietary supplements and health foods. We market our legal expertise. Most of the time, we have the same concerns as any other business. Working with my partner, Marc Ullman, is a pleasure because we work so well together. The most important decisions that I make on a regular basis are those that affect my clients, their companies and the products that they market. Having advised companies in the dietary supplement industry for 24 years, it is a position that I take seriously and an industry that I enjoy being a part of.
Health E-Insights: If a news crew from 60 Minutes walked into your client’s office unannounced, what would you tell your client to do?
Mr. Shapiro: It has happened more than once, although it might not have been 60 Minutes. Generally, I do not believe that the media is your friend. I can think of many examples where companies have allowed the media in thinking that they could outsmart them and the end results were never good. A while back an overly persistent news crew refused to respect my client's wishes to leave the grounds, and I, only half-jokingly, suggested turning on the sprinkler system. All kidding aside, one needs to be properly prepared in order to deal with the media. In the worst case scenario, it is always best to put the proper team together, which usually would include legal counsel, public relations and when appropriate, crisis management before you try to talk to the media. Properly trained and adequately prepared, it is usually possible to survive even the worst case scenarios.
Health E-Insights: What are you passionate about?
Mr. Shapiro: My first answer would be golf, but I haven't gotten to play in a long time. That will be my passion in retirement. I become very passionate when I see injustice. Despite my parents' trying to push me to medical school, they were not surprised when I opted for law school. I have been told that my favorite expression as a child was, "that's not fair." My passion for "health freedom" first came about on a fateful day in June of 1988 when I met Robert Ullman and Milton Bass. But I am happy to debate anyone at any time on life's great issues.
Health E-Insights: What would you do if you weren’t in your present position?
Mr. Shapiro: This is not something that I have given all that much thought to, but now that I think about it, I have always enjoyed doing presentations at the trade shows and writing for the trade press. So, something that involves communicating and educating the public, perhaps an author or journalist. In an alternate life, I could have been the 60 Minutes journalist knocking at your door.
Sheldon Baker is well-known for creating nutraceutical brand marketing and public relations campaigns. For Health E-Insights interview consideration, contact him atBaker@CentralValleyTalk.com. And follow him on Twitter @NutraInk.
Health E-Insights: What pending legislation could impact the industry?
Mr. Shapiro: There does not seem to be any legislation affecting the industry that is likely to pass this session. But that does not mean that the industry can just sit back and relax. Other industries make their presence felt in Congress with far more lobbying than the dietary supplement industry ever does. In this country, for regulated industries, lobbying is the name of the game. Recently, Senator Richard Durbin was able to schedule a surprise amendment to a pending, must-pass FDA User Fee Act, which would have required dietary supplement facility registration and listing of all products and their ingredients with FDA. Prompt mobilization by industry with calls to Senators on a day's notice killed that amendment. Such vigilance must, however, be never ending and not just simply in response to a potential crisis. Regular interaction with Congress is essential, particularly as our industry champions leave Congress and fewer and fewer members were there for the passage of DSHEA.
Health E-Insights: Are there other industry concerns besides legislation?
Mr. Shapiro: My concern is that FDA is biding its time and very patiently undercutting aspects of DSHEA without taking the time to involve Congress by issuing draft guidances that contradict DSHEA and "chill" innovation. In addition to the well discussed concern about the draft new dietary ingredient guidance, Senator Durbin's recent letter to FDA demanding that the agency enforce its 2009 Draft Guidance affecting liquid dietary supplements and beverages continues to remain a concern. Under DSHEA, a dietary supplement could physically resemble a conventional food so long as it was not represented as a conventional food by being called a "drink" or a "cookie." Senator Durbin and FDA, apparently out of some concern over liquid energy supplements, are seeking to "re-write" DSHEA without bothering to go through Congress. The draft guidance would be a substantive change in the Agency’s statutory and regulatory policy toward how it distinguishes dietary supplements from conventional foods and beverages. For the first time, in contradiction to 18 years of policy and public statements, FDA has used a draft guidance to announce that a product's physical form and packaging, together with the volume of liquid consumed will be determinative factors in whether a product will be regulated as a dietary supplement of a conventional beverage.” Thus, ingredients in such products would be subject to "food additive" status and a safety standard, which the FDA must perceive as less onerous that the "significant or unreasonable" safety standard that applies to dietary supplement ingredients. Moreover, FDA can extend its analysis right down the slippery slope to such things as "bar" dietary supplements that are packaged similarly to candy bars, powder dietary supplements that are packaged similarly to breakfast drinks or "gummy" vitamins that look like candy. There is a reason that packaging has not been a factor in making this determination and FDA should not finalize a guidance that would make it a determinative factor now.
Health E-Insights: What do you consider is the biggest legal hurdle supplement companies face?
Mr. Shapiro: Without question, the biggest legal hurdle for the dietary supplement industry going forward is going to be compliance with the FDA's Good Manufacturing Practice (GMP) regulations. I view these regulations as taking the industry from childhood into adulthood. Obviously, for the industry to grow and prosper, consumers must be confident that products are properly labeled and contain exactly what the label says that they contain. As raised by Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, at the American Herbal Products Association's recent Botanical Congress in New York, it is frightening that during inspections FDA is finding that such a large percentage of companies are failing to have implemented or comply with even the most basic requirements of the new GMPs. Clearly, FDA is taking its obligation to ensure compliance seriously and appears to be taking prompt action against companies that are failing to meet their obligations. According to Dr. Fabricant we should expect to see more inspections, more injunctions, and more product seizures related to failure of companies to comply with the basic GMP requirements.
Health E-Insights: What are the most important decisions you make as a partner of your firm?
Mr. Shapiro: I provide legal services to an industry that I care deeply about, but am also running a business. Many of our clients market dietary supplements and health foods. We market our legal expertise. Most of the time, we have the same concerns as any other business. Working with my partner, Marc Ullman, is a pleasure because we work so well together. The most important decisions that I make on a regular basis are those that affect my clients, their companies and the products that they market. Having advised companies in the dietary supplement industry for 24 years, it is a position that I take seriously and an industry that I enjoy being a part of.
Health E-Insights: If a news crew from 60 Minutes walked into your client’s office unannounced, what would you tell your client to do?
Mr. Shapiro: It has happened more than once, although it might not have been 60 Minutes. Generally, I do not believe that the media is your friend. I can think of many examples where companies have allowed the media in thinking that they could outsmart them and the end results were never good. A while back an overly persistent news crew refused to respect my client's wishes to leave the grounds, and I, only half-jokingly, suggested turning on the sprinkler system. All kidding aside, one needs to be properly prepared in order to deal with the media. In the worst case scenario, it is always best to put the proper team together, which usually would include legal counsel, public relations and when appropriate, crisis management before you try to talk to the media. Properly trained and adequately prepared, it is usually possible to survive even the worst case scenarios.
Health E-Insights: What are you passionate about?
Mr. Shapiro: My first answer would be golf, but I haven't gotten to play in a long time. That will be my passion in retirement. I become very passionate when I see injustice. Despite my parents' trying to push me to medical school, they were not surprised when I opted for law school. I have been told that my favorite expression as a child was, "that's not fair." My passion for "health freedom" first came about on a fateful day in June of 1988 when I met Robert Ullman and Milton Bass. But I am happy to debate anyone at any time on life's great issues.
Health E-Insights: What would you do if you weren’t in your present position?
Mr. Shapiro: This is not something that I have given all that much thought to, but now that I think about it, I have always enjoyed doing presentations at the trade shows and writing for the trade press. So, something that involves communicating and educating the public, perhaps an author or journalist. In an alternate life, I could have been the 60 Minutes journalist knocking at your door.
Sheldon Baker is well-known for creating nutraceutical brand marketing and public relations campaigns. For Health E-Insights interview consideration, contact him atBaker@CentralValleyTalk.com. And follow him on Twitter @NutraInk.
