Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have been coming down fast and furious on food, beverage and dietary supplement companies in recent years.
The FDA is focused on eliminating unsafe or adulterated products from the market, as was reflected in the agency’s announcement yesterday that it is stepping up actions to eradicate tainted supplement products from U.S. market. Meanwhile, the FTC is focused on ensuring companies no longer market or label their products with unsubstantiated health claims. The agency’s latest victory in this effort also came yesterday, when the Dannon Company agreed to pay a $21 million settlement with the FTC and individual state agencies over charges of deceptive advertising for its Activia and DanActive products.
NewHope360.com spoke today with longtime food and dietary supplement legal expert James Prochnow, an attorney with the law firm Greenberg Traurig, about these and other recent regulatory-related events. Below is an edited transcript of our conversation.
Dannon’s $21 million settlement is the largest of its kind involving alleged deceptive claims by a food company. What does this settlement mean for Dannon and its products?
James Prochnow: Dannon has been involved in a lot of litigation over the last year. I don’t know if this will be its last settlement, but it is another significant step in the company’s efforts to put behind it the controversy surrounding its lack of scientific support for the claims that it has made for Activia and DanActive.
Dannon maintains that it did nothing wrong regarding its DanActive claims. Why do think the company settled on everything rather than attempting to take on the FTC as POM Wonderful is doing?
JP:I think POM Wonderful reacted too quickly by filing its lawsuit against the FTC.
All of this is part of what has been to me a very obvious effort by the government agencies over the last three years to give a strong push toward both food and dietary supplement companies to get more science behind their claims. I have been advising clients for five years to do this, and every month it becomes more obvious that good science—not marginal or trick science—is absolutely necessary to sell products that people are being asked to put into their bodies. This latest Dannon-FTC consent decree is the latest punctuation mark in the call for better science. And it’s not just the government making the call—it’s also the responsible trade associations and responsible companies.
Food safety bill emphasizes need for better science
In what other ways is the government mandating the need for better science?
JP:The Food Safety Modernization Act emphasizes the need to have good science to make sure your products are not adulterated, while the FTC is focused on having good science to support advertising claims. Both are important.
What improvements need to be made to the science currently supporting food and dietary supplement products?
JP:For a lot of companies it will involve a retooling of their thinking about the role of research and development. Companies in this industry have made a lot of money, and they will have to devote a bigger percentage of their net profits or even their gross sales to good science. There also have to be better internal controls over how marketing departments make claims for a company’s products.
Often times I am asked to take a good look at whether the science actually supports a company’s marketing claims or to get involved when there is a clash between the legal and marketing departments. When this happens, my basic advice is this: Be as sure as you can that what you are saying is true. It’s really that fundamental. Of course, there can be legitimate differences of opinion regarding whether scientific studies support claims or not. People tend to think of science as being an absolute thing, but science can be an opinion as well.
Two clinical studies not the de facto substantiation requirement
In its consent decree with Dannon, the FTC said the company would need to provide two clinical studies to support future claims made for its Activia and DanActive products. What does this mean for the broader food and dietary supplement industries?
JP: The agency is not saying you need two clinical studies to support all claims; it says you need competent and reliable science. This is a good standard. However, because it has Dannon on the ropes, the FTC will now require that company to do two studies for future claims that it makes.
Of course, the fear is that by requiring Dannon to produce two clinical studies to support future claims, that will become a de facto substantiation standard for all FTC decent decrees. Do you see this happening?
JP: In real life at the present time, you rarely see two scientific studies to support one claim. Therefore, the FDA and FTC won’t try to regulate the world—which they have helped to construct—in a way that is unrealistic or artificial. The FTC’s requirement is for one clinical study for each important claim. But again, because the agency has Dannon in its crosshairs, it is saying that company will need two clinical studies in the future.
Do you think the Food Safety Modernization Act will be enacted this year?
JP: The Senate approved it yesterday, and I’ve read that it could be approved by the House today. I think it will be signed by the President before the end of year, probably before Christmas. The act as a whole will become effective when signed, but different provisions of the bill will take effect at different times.
What are some of the ways in which the food safety bill could affect the food and dietary supplement industries?
JP: The bill gives the FDA mandatory recall authority, but only if there is evidence of a product causing death or posing significant danger to consumer health. This is the emphasis throughout the entire act. Many things come into play when there is a risk of death but not as a regular course of business.
Import safety is a primary focus of the bill. I do a lot of work for companies that get their products detained from China, usually either at ports in Los Angeles or Alaska. This has been going on now for three years. Two things usually prompt detainment. One is that people are sloppy in their shipping document paper work. As a result, companies will now have to be more careful in this paperwork. FDA will take criminal action if you lie on shipping documents.
The second common trigger is evidence that ingredients that were not called for in the specifications of product are being included by Chinese exporters—often this happens unbeknownst to the importer. Big section of the food safety bill focus on lab practices. The uninitiated public often thinks that it is easy to test for adulterants, but that is not the case. Sometimes labs can only find adulterants if they know what to look for, but this doesn’t help in those cases where new types of molecules have been added to a product. Testing can be very complicated, so government will have to work with industry to develop new methods of detection.
The issue of ingredient testing is one that came up yesterday in the FDA’s announcement that it is stepping up its efforts to stop the manufacture, distribution and sale of tainted dietary supplements. The FDA is asking manufacturers to be more vigilant when it comes to their qualifying their supply chains and ensuring that they are not using adulterated ingredients in their products. Yet, as you note, this can be a very complicated and difficult process.
JP:I have been involved with the FDA on the tainted supplement issue, so the agency’s announcement yesterday came as no surprise to me. This is a complicated issue because what often happens is that a product comes in from China and it ends up working better than people thought it would be working. So the importer or even the government does some analysis and finds a substance in the product that the importer did not know was there. That is very common. We have seen many recalls and criminal investigations associated with these illegal and often dangerous products.
In these situations, would the importer be held criminally liable—even if it did not know the tainted substance was in its product?
JP: It is illegal to sell adulterated substances in the United States, so there is absolute liability for that—that means criminal liability as well. However, the FDA’s posture has been to deal with situations where people knew something was in the product or acted recklessly. The FDA’s criminal investigations usually focus on intentional acts: You knew an undeclared substance was going into the product or you intentionally altered shipping documents or test results.
But what if a company just doesn’t do any testing at all? Would that company be criminally liable, especially if they are operating in one of the three categories that have been identified as being particularly vulnerable to tainting: male sexual enhancement, weight loss and body building?
JP:The FDA usually focuses on those companies that intentionally taint a product. The reason why is because sometimes adulteration can occur through manufacturing contamination. Also, criminal investigations take a long time and have dire consequences, so the government needs to be pretty sure that someone did something intentionally wrong before accusing them of a crime.
That said, if you are operating within those three categories, the red flag is already up, so you would be wise to qualify your supply chain and do good testing.