July 1, 1982: The Food and Drug Administration announces that it considers diet-aid pills known as starch blockers to be unapproved new drugs and asks manufacturers and distributors of the tablets to discontinue marketing them pending such approval.
Summer 1983: Starch blockers are being sold in at least five Washington health food stores.
AFTER MORE than a year, confusion continues over the status of starch blockers, a product that its manufacturers claim inhibits the body's absorption of starch, allowing people to eat such foods as spaghetti and potatoes without the worry of gaining weight. Managers of local health food stores that still sell the pills say they either don't know of FDA's pronouncement or that they can continue selling starch blockers until a court orders them to stop.
The controversy began in 1981 when the product gained national attention and consumer inquiries started filtering in to the FDA. The issue took the form of legal warfare when in July 1982 the agency declared starch blockers to be drugs that could not legally be marketed and subsequently was sued by 17 companies in two separate lawsuits.
Manufacturers and distributors of the pills claimed that since their products were made from kidney beans, they are foods and therefore not subject to the safety and effectiveness tests that the FDA requires before drugs can be marketed. The FDA stated that the product fit the agency's definition of a drug because starch blockers are "intended to affect the structure or function of the body." Now, the issue continues to be whether FDA approval of starch blockers is required, not whether the pills are safe and effective.
One of the cases is in Chicago, where a federal court's decision in the FDA's favor was upheld on appeal Aug. 8. The other (which includes among the plaintiffs, General Nutrition Center and American Health Products, manufacturers of two of the products being sold in Washington) is pending in New York. According to Larry Roth, an attorney representing the companies in the New York case, "FDA's decision-making process is subject to the review of the courts."
When the FDA made its July 1, 1982, announcement, it sent letters to more than 300 manufacturers and distributors stating that the marketing of starch blockers constituted a violation of the Food, Drug and Cosmetic Act. Continued marketing could result in regulatory action, wrote the FDA. Although the letters were not sent to retailers, the FDA is "not required as a legal matter to inform store owners," said FDA spokesman Bruce Brown.
The FDA has three enforcement options against retailers, manufacturers and distributors of starch blockers. The agency can, with court approval, seize the products; ask a court for an injunction prohibiting the sale; or recommend to a U.S. attorney that criminal prosecution be initiated. As a result of the lawsuit in Chicago (unless the companies appeal to the Supreme Court), the companies must halt all manufacture and distribution of starch blockers, destroy all of their inventory and pay the cost of FDA reinspection of their facilities to assure compliance. This order only applies to the seven companies involved in the suit; every company manufacturing starch blockers has the right to a day in court, according to the FDA. In addition, said Brown, retailers who continue to sell residual pills manufactured by the seven companies are not under legal obligation to comply with the order of the court decision.
To date, the FDA has seized more than $3.5 million worth of the diet aids around the country, although the agency's strategy has been to go ----after "large size lots," not individual stores. According to Brown, the agency initiated seizures at the wholesale level last September and is now concentrating on areas with a large number of offending stores. (On July 15 of this year, the agency seized starch blockers from General Nutrition Centers in six Connecticut towns. "We are disappointed that they made that seizure before the outcome of the federal trial," said Dr. Robert Thompson, director of nutrition education at GNC).
According to Dr. Beth Whelan of the American Council on Science and Health, the "FDA doesn't have the manpower," to prohibit starchblocker sales.
"Any individual store is only going to have a couple hundred dollars worth of stuff," said Brown, in regard to Washington's sales. According to Brown, it "costs the taxpayermany times that to get a seizure order signed by a judge and executed by U.S. marshals."
The main reasons for the continuation of local sales are three-fold, said Brown. The first may be that store personnel do not understand that the FDA considers the marketing of starch blockers to be illegal. Secondly, some of the stores "are in out-of-the-way places and never heard the word." And lastly, "people are legitimately confused," said Brown, citing the two lawsuits and conflicting word-of-mouth reports as the causes.
In a survey of about 50 area health food stores, the majority said they no longer sell the pills because "the FDA took them off the market," or "they're illegal." All local stores that are still selling the tablets are getting rid of residual stocks, not newly manufactured pills, confirmed both the stores and manufacturers. Store managers appear to be "legitimately confused," about the pills' status, as Brown said, while others are selling under the assumption that they may until personally notified by the FDA.
Bill Butler, district manager of the Natural Nutrition Shoppes, who said that the company reintroduced their product Starch Control about two months ago after previously removing it from the stores, said he was told by the chain's main office that "there was never a final ruling as far as their the FDA's claims of it being a drug" and that he had heard that "stores had to receive notice to have it taken off the shelves."
"We need to be notified by FDA " about any rulings, said Shirley Pettingell, manager of Nature's Outlet in Springfield, who said she is still selling starch blockers although they are "a dead product."
Other area stores that are selling them say they do so with hesitation. "When people come in and talk about losing weight, we don't recommend them," said Charlie Krisfalusi, manager of Super Nutrition Shops Inc. in Baileys Crossroads, who sells the starch blocker Vita-Plus for $8.95 for 30 tablets. (Vita-Plus in Las Vegas says it no longer manufactures the product.) Krisfalusi said he heard starch blockers could no longer be manufactured or distributed, but thought that the FDA was "not going to force us to take it off the shelves." Since the agency made its announcement last year, said Krisfalusi, the store has sold about two or three dozen bottles. According to Krisfalusi, one woman bought about a dozen a few months ago. "She wanted to make sure she could get enough."
And at Natural Extravaganza on Connecticut Avenue in the District, the product has been going on and off the shelves. When owner Yessey Pesome is there, she removes them because she said she "doesn't like anything that stops the body's functions." But Pesome said Alpha-Slim Starch Inhibitor was recently reshelved by the store's new manager, when Pesome wasn't there. (Naturade, the Paramount, Calif. company that used to make the product, said it no longer manufactures Alpha-Slim).
At least two other stores said they do not display the item on their shelves, but will sell to inquiring customers from their stock rooms--sometimes at reduced rates.
There's added confusion among consumers about the status of starch blockers. Requests for the tablets are still coming in from patrons, say the local stores. Sol Newton, manager of Woodlawn Pharmacy, said that "people come in all the time" inquiring about the pills, although "right now we're high on the Cambridge Diet." And at California Nutrition in Vienna, owner Emery Stith said the store still gets requests for them even though they sold out last July when "people came in and hoarded it." There's a "section of the community that doesn't believe in the FDA," said Stith.
Verbal warnings accompany other sales. At the Natural Nutrition Shoppes in the Connecticut Connection, the store manager warned this reporter before she purchased Starch Control that the product "could cause diarrhea."
Although the interpretation of the Food, Drug and Cosmetic Act is the issue at stake in the court cases, and not whether the tablets are safe or effective, when the FDA ruled starch blockers to be drugs, the agency had received reports of stomach disorders and hospitalizations. Attorneys for the 17 companies that sued the FDA claimed that the agency's evidence did not show a direct correlation between the starch blockers and the hospitalizations. "That's a crock," said the FDA's Brown. "They're the attorneys just blowing smoke."
As for starch blockers' effectiveness, "nobody disputed the fact that it works," said Kirkpatrick Dilling, attorney for companies that sued--and recently lost to--the FDA in Chicago. By taking a starch blocker and eating a plate of spaghetti, said Dilling, you "reduce the calories to zilch."
Thompson of General Nutrition Centers, the 1,100-store nationwide chain, with about a dozen stores in the Washington area, said that the companies' research and development office--which employs six doctors and about 50 chemists--performed a series of starch blocker tests. Feeding human subjects 150 grams of mashed potatoes with Advantage, the company's pills, the results showed that the enzyme that breaks down starch was inhibited from doing so. But Thompson emphasized that the more immediate issue is FDA's authority to change the classification of the product. "We feel it's a precedent that's not in the best interests of the public." If unchallenged, "they the FDA could do the same thing with cod liver oil," he said.
Brown said that since July, the FDA has received five studies from clinical researchers, all of which prove that starch blockers are "ineffective in passing starch through undigested."
Tom Walsh, an assistant U.S. attorney and trial attorney for the Chicago case, said he believes the studies are correct. "It goes to show you you can sell almost anything," he said.