Now peas are a food additive and carrots are a food additive. In fact, FDA's lawyer admitted that black currant oil itself posed no danger; the problem was that there was no data supporting the safety of black currant oil in a gel cap. FDA was essentially arguing that the Generally Recognized As Safe list, which was first created to regulate chemical food additives, should be interpreted to include dietary supplements ingredients.
This distinction was key to FDA enforcement efforts, because if dietary supplements ingredients were considered foods, it was up to FDA to prove they were unsafe. However, if they were considered food additives, the burden of proof for safety lay squarely on the manufacturer. During the proceedings, Ullman asked if FDA's lawyer would have any safety concerns about consumers drinking black currant oil straight out of the bottle.
FDA's lawyer responded that no one would do such a thing. Was it a food? Was it an additive? It turned out that, by mistake, Ullman had grabbed a bottle of olive oil, but no one knew that at the time. The presiding judge, Harold A. Baker, found in favor of Traco Labs on April 10, FDA appealed to the Seventh U. The Jan. On June 8, , the U. District Court for Massachusetts found in favor of Oakmont, saying the FDA argument that adding black currant oil to a capsule turns it into a food additive "defenestrates common sense.
What, ultimately, was the impact of these rulings? As a result of overreaching, FDA eventually lost the very market preapproval for dietary supplements that it was fighting so hard to protect. To the extent that these cases bolstered both public and congressional support for a bill such as DSHEA, they had a direct impact on the current regulatory situation.
Congress received more mail from constituents in support of DSHEA than it had for any other single piece of legislation in history. Natural products retailers were a key element in mobilizing this public outcry against FDA's heavy-handed tactics. At the time she was a retailer with Nature's Fresh Northwest and president of the northwest region of the National Nutritional Foods Association.
Of course, there was some self-interest involved: Supplements were a high-margin product, and losing the entire category would have put many stores out of business. But the driving force behind retailers' activism was the belief that consumers should be able to make their own health choices. Vitamins with anything above the [recommended daily allowance] would no longer have been for sale.
Herbal products would have been gone, unless used as an herb or spice. Retailers became activists to protect consumer health freedom. Sandy Gooch, founder, owner and director of marketing for the Southern California-based naturals supermarket chain Mrs. Gooch's, was a key figure in this nationwide education campaign.
Few people, especially in FDA, thought this grassroots movement had any chance of achieving its agenda through legislative means. But the natural products industry has always been an industry of true believers.
From the standpoint of being a positive person and an entrepreneur, I just thought, 'Let's get this done,'" said Gooch. We must. It is estimated that 52 percent of consumers over 19 take dietary supplements. While there has not been consensus with the approach used to accomplish these ends, on balance the core elements of the regulatory framework envisioned by the authors of DSHEA are in place.
Dietary supplements have a legal definition; there are comprehensive requirements in place for advertising claims that ensure that consumers have access to truthful and non-misleading information; and there is strong legal authority to remove unsafe products from the market, cease deceptive advertising and provide redress to consum- ers when appropriate. Available at: www. All rights reserved. Sills Cummis litigators represent multinational corporations, financial institutions and government bodies, often in complex and important matters.
Our attorneys are active in pre-trial, trial and appellate matters in federal and state courts, as well as administrative litigation, grand jury investigations, and arbitrations. We staff our matters intelligently and Skip to main content. New Articles. Walsh Jr and Jeffery R. Swor and Rachel L. Kennedy, Jr. Rinearson and Andrew M. Adler What is an organization required to do in Europe if it engages in Zetoony Computing on the Edge by: Robert M.
Kamer and Aubrey A. Slack and Peter A. Paolillo and Ellen L. Mitchell and F. Delaney and Kristina M. Kahlon and Aron C. Thomas and Michael P. Neifach and Otieno B. Porzio and Joshua S. Bryan What a Deal! Ferrante and Nathaniel M. Porzio and Elizabeth A. Bourne and Daniel J. Ferrante and Jana L. Demand for dietary supplements remains more robust than ever, especially in the wake of a global pandemic. But consumers have become more proactive when it comes to the ingredients that go into the supplements they take.
As a result, dietary supplements manufacturers remain under growing pressure from consumers and regulators to manage label claims more effectively and transparently. Congress passed the U. Dietary Supplement Health and Education Act of DSHEA in response to this increased pressure to regulate dietary supplements and provide consumers with more information.
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