In memory of Ben Zaricor, 1947-2022

Fmali v Heckler: The landmark herb case that changed the industry

By Stephen Daniells contact

- Last updated on GMT

Schisandra chinensis or five-flavor berry on a branch. The berries possess all five basic flavors in Chinese herbal medicine: salty, sweet, sour, pungent (spicy), and bitter.   Image © Geshas / Getty Images
Schisandra chinensis or five-flavor berry on a branch. The berries possess all five basic flavors in Chinese herbal medicine: salty, sweet, sour, pungent (spicy), and bitter. Image © Geshas / Getty Images

Related tags: Herbal supplements, Schisandra, Lawsuit, Fda

It started with ten-speed bicycles and ended with an Appeals Court decision in 1983 that changed the herb industry and knocked FDA down a peg. Four decades later, it’s time to shine the spotlight on this game-changing court case.

The story focuses on Ben Zaricor and Louise Veninga, a husband-and-wife team that had finished college in the Midwest with an idea to start a company with some friends selling ten-speed bicycles. When the shipment of bikes failed to materialize, the Zaricors took a trip to California, during which a visit to San Francisco’s Chinatown led to the discovery of Tiger Balm​ and ginseng.

Convinced that there was a business for both products outside of Chinatown, the Zaricors tested the market in Colorado before expanding and traveling the country to establish business contacts and researching ginseng and other botanicals.

Louise authored The Ginseng Book​, “a seminal publication at the time”​, according to Mark Blumenthal, founder and executive director of the American Botanical Council. “It was the first book on ginseng in English in 100 years,”​ Louise told me during a telephone interview.

The early to mid-1970s also saw a coalescence of an herbal community around health food stores and shows in California, recalled Ben during the same interview.

FDA becomes more “restrictive”

At the same time, the US Food and Drug Administration (FDA) was adopting a more aggressive stance against herbal products and vitamins.

One well known example was the FDA’s final rule to limit the potency of vitamins to 150% the daily RDA (Recommended Daily Allowance) that was finalized in the Federal Register​ in 1973. The 1976 Proxmire Amendment (named for the efforts of then-senator from Wisconsin William Proxmire) stopped the Agency from imposing these limits*. 

(* The Proxmire Amendment also prohibited the classification of food supplements as drugs. The term ‘dietary supplement’ would not be defined until the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.)

Another FDA move in the mid-1970s was to change the parameters of what constituted “common use in foods”, which had important consequences for those selling herbal teas: The Food Additives Amendment of 1958 amended the Food, Drugs, and Cosmetic Act of 1938 to establish an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. In 1974, FDA had issued a regulation to explicitly state that “common use in food” related specifically to the US.

“FDA in the mid-1970s had a tendency to be more restrictive,” ​explained Michael McGuffin, president of the American Herbal Products Association (AHPA). (To hear more from McGuffin on the case, please click HERE​.)

Enter William Pendergast

There was also increased scrutiny of shipments coming in from China, recalled Zaricor. “Occasionally our shipments were stopped, but we’d get them back because we had quality herbs from the right places,”​ he said.

The herb community began to consider how to deal with the “FDA problem”, said Zaricor, who remembers that veteran brokers suggested they start a trade association to deal directly with FDA

The Herb Trade Association was founded in 1976 and lasted until 1980/81 (the HTA was forerunner to AHPA, which was founded in 1982). The HTA’s first co-president was Ben Zaricor.** The first treasurer, Louise Veninga.

If the Agency was to be challenged, then HTA and Fmali needed a lawyer. Enter William (Bill) Pendergast from D.C.-based law firm Hamel, Park, McCabe & Saunders.

“Bill was from a political family in Kansas City called the Pendergast Machine,” ​noted Zaricor. “He was a brilliant man.”

In the meantime, Fmali had begun selling a product known as renshenfengwangjiang, a combination of Asian ginseng extract and royal jelly that also contained schisandra fruit. “We were making tremendous sales,”​ recalled Zaricor, and distributors started putting the products into stores.

With the money they were making from selling their herbal products, “we could afford to do some things for the industry,” ​said Zaricor. “One of the things we could do was challenge the FDA.”

At the start of the 1980s, Fmali made their move and filed suit against the FDA. According to court documents from the time​, “Fmali brought the action in order to obtain pre-enforcement review of the FDA's regulation”​, and the company and Pendergast used renshenfengwangjiang as the key: The FDA’s position was that the product could  be sold in the US only if it did not contain schisandra, a relatively unknown herb in those days. This was based on the “common use in foods”.

“The FDA held that evidence of long and widespread use of schizandra seed*** in China is not admissible in aid of establishing that schizandra seed is safe for human consumption,” ​stated the court documents.

On the other hand, Fmali’s position was that “so long as proof is documented that herbs were and are used as safe food or tea ​[anywhere in the world], then the FDA should not prohibit their sale and distribution as a tea or food”, ​(source: 1982 press release from Fmali Herb Co.).

“Fmali wishes to clarify the regulation by allowing the Court to rule that FDA’s interpretation is discriminatory and with no basis of law by limiting its interpretation to prior use in the U.S.A.”

“Wow, Fmali won!”

While Fmali had some money to finance the case, they did ask for financial support from the industry. “Some industry friends did step forward and offer financial support, but many did not,”​ noted Zaricor.

Loren Israelsen, president of the United Natural Products Alliance, remembers the case. In the early 1980s Israelsen was General Counsel for Nature’s Way. “A few people were aware there was a lawsuit, but the overall feeling was there was little to no chance of winning this thing,” ​he told me. “I remember Ben made requests for industry support because Ben and Louise felt this was important, but I think a lot of people didn’t understand the legal principle, and many thought that industry couldn’t win against FDA.”

Initially, Fmali didn’t win this thing: A judge for the Federal District Court of San Francisco ruled in favor of the FDA.

Fmali appealed, and the case went to the United States Court of Appeals for the Ninth Circuit. Now known as Fmali v Heckler (the Heckler in question being Margaret Heckler, Secretary of Health and Human Services in 1983), the judges reversed the lower court's decision and decided in favor of Fmali.

“We conclude that, even according the deference due an administrative agency's interpretation of a statute that it is responsible for enforcing, the challenged FDA regulation does not fairly reflect either the language or purpose of the "common use in food" portion of section 201(s),” ​stated the decision.

“There was surprise,”​ said Israelsen. “Wow, Fmali won!The fact that it was an Appeals court decision only raises the legitimacy of the decision,”

Herbalgram cropped
A section of the coverage of the case in Herbalgram #2 in 1983, reproduced with permission from the American Botanical Council (ABC)

The case received limited coverage: There was an article in Herbalgram​ #2 in 1983, five years before the American Botanical Council (ABC) was founded.

“The Fmali case allowed foreign-sourced herbs to be imported into the U.S. for use in teas and possibly food supplements based on the assessment of their safety based on history of use – with such history not being limited to use in the USA only – which was the US FDA’s narrow (mis)interpretation of the food additive provisions of the 1958 law,” ​explained ABC’s Blumenthal in an email.

“It didn’t necessarily open the floodgates for more imports of foreign herbs, but it did lubricate that process. (History of relatively safe use in foreign cultures became a new criterion for safety assessment, but not the only criterion.)”

Legacy

Ben and Louise continued in the industry for many years: Fmali became the leading supplier of herbal ingredients for Celestial Seasonings, Thomas J. Lipton, and many other tea, herb, and spice companies. In 1993 they bought the trademark rights of Good Earth for all the restaurants, teas, and other food products. They sold Fmali in 2005, with Zaricor staying on as CEO until 2006. 

ABC’s Blumenthal remains friends with the Zaricors and has no doubt about the important contribution they and Bill Pendergast made to the industry. “Fmali v Heckler is a landmark in the history of the modern herb industry, likely the most important decision – or at least one of the most important – until the passage of DSHEA 11 years later,” ​he said.

The case should receive more recognition, said Israelsen, but even at the time it’s not clear that everyone appreciated the significance. “I think the lawyers advising companies understood the importance, but many other folks didn’t,” ​he said.

And in the pre-internet age, the Zaricors didn’t go around lecturing people about it. “We’re pretty low-key people,”​ said Ben.

While a few in the industry recall the case, its impact is clear to this day: It changed the world for the US herb community:

“Without Fmali, the herb industry may have been a furtive, underground market,” ​said Israelsen. “Without Fmali, the herb industry certainly wouldn’t have kept pace with the other categories.”

 

Editor's note: Ben Zaricor passed away on June 8, 2022. To read more about his life and achievements, please see this article in HerbalEGram​. 

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Notes:

** Mark Blumenthal explained that HTA initially had 3 presidents: Ben Zaricor, Caroline MacDougal (who worked at Celestial Seasonings at the time and now is founder and owner of Teeccino), and the late Barry Meltzer, who owned San Francisco Herb and Natural Food Co., an herb importer and wholesaler. “The thinking of many of the hippie-type early herb industry folks was that they didn’t want concentration of power in one individual, hence the tripartite presidency of HTA in its initial year,”​ he said.

That changed in the second year, he said, when John Hay of Celestial Seasonings was elected president, followed by Blumenthal himself, who at that time was running his own company called Sweethardt Herbs.

*** While the court documents from 1983 refer to “schisandra seed”, Schisandra is actually a fruit. The berries of Schisandra chinensis ​are known as wu wei zi​ in Chinese, which translates as "five flavor fruit":  because they possess all five basic flavors in Chinese herbal medicine: salty, sweet, sour, pungent (spicy), and bitter.

According to a review by Panossian and Wikman in the Journal of Ethnopharmacology​ (2008, Vol. 118, No. 2, pp. 198-212), the berries are used in traditional Chinese medicine for a range of endpoints, including to infection resistance, and to improve skin health, insomnia, coughing, and thirst.

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