How the dietary supplement industry keeps regulation at bay
In early June, at the request of the Food and Drug Administration, U.S. Marshals seized more than 300,000 containers of dietary supplements, including tablets, capsules and teas from Life Rising Corp. that were manufactured and distributed under conditions that do not meet the FDA’s manufacturing requirements.
Despite the FDA’s plans to modernize regulation of dietary supplements, any firm regulatory changes are still a distant prospect. The nutritional and dietary supplement industry has long had strong allies in Congress who support industry-friendly legislation that maintains the status quo of self-regulation.
Setting the industry standard
The last major legislation to strengthen regulatory oversight of dietary supplements, the Dietary Supplement Health and Education Act, was passed 25 years ago. The bill was introduced in 1994 by former senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa).
The law classified many over-the-counter nutritional and dietary products as food rather than drugs. It also prohibited manufacturers and distributors of dietary supplements and dietary ingredients from marketing products produced in a contaminated environment or containing harmful ingredients, as well as those that are deceptively labeled or have unproven claims.
However, the FDA is not responsible for harmful products until after they reach the market, so the agency can’t take regulatory action until a tainted or mislabeled product is possibly already in the hands of a consumer.
This act, touted by President Bill Clinton as “bring[ing] common sense to the treatment of dietary supplements under regulation and law,” effectively set the standard for lax government regulation of the supplement industry.
Throughout their careers, Hatch and Harkin worked to ensure that the responsibility of oversight and regulation falls on the supplement industry rather than the FDA. They were duly rewarded for those efforts. From 1990 through their retirements, the two were regular recipients of nutritional and dietary supplement industry campaign contributions.
Hatch received $475,637 throughout his career, the most of any member of Congress, and Harkin received just over $300,000. Hatch and Harkin were involved in passing several dietary supplement-related bills, including a 2006 bill that required non-prescription drug manufacturers to report adverse effects caused by their drugs or supplements and 2010 legislation to fully implement their 1994 law.
Several dietary supplement companies and interest groups lobbied on the 2010 bill, including one industry group that hired a lobbying firm where the Utah senator’s son, Scott Hatch, worked as a registered lobbyist.
According to Daniel Fabricant, CEO of the Natural Products Association, “Any FDA reforms in the past 35 years, Sen. Hatch’s fingerprints were on it.”
Similarly, Michael McGuffin, president of the American Herbal Products Association, called Harkin a “champion of the dietary supplements and organic products industry.”
“Looking forward, our goal should be to find new friends on Capitol Hill, who will support and promote the industry a fraction as well as Senator Harkin has,” McGuffin added.
Harkin and Hatch retired in 2014 and 2018, respectively. Since then, the industry has worked to build support in Congress and fill the void left behind, giving a record $9.7 million during the 2016 presidential election cycle and spending more than $38,000 in preparation for the 2020 presidential election cycle. Eighty-three percent of this spending has gone to Democrats and only 17 percent to Republicans. The industry tends to play both sides of the aisle. In 2018, they gave only thirty-five percent to Democrats and sixty-five percent to Republicans.
In 2017, Rep. Mia Love (R-Utah) took on a new leadership role as a co-chairwoman of the Congressional Dietary Supplement Caucus, a bipartisan forum for sharing information on dietary supplements. Love, from Utah like Hatch, acknowledged that the industry is a crucial part of Utah’s economy. In the 2018 cycle following this new role, she became one of the industry’s top recipients raking in $51,540 for that cycle. She still lost her re-election bid. Two of the other top recipients of industry money in 2018, Reps. John Curtis (R-Utah) and Tony Cardenas (D-Calif.), receiving $27,800 and $16,067 respectively, are co-chairmen of the caucus.
The Senate Committee on Health, Education, Labor and Pensions has jurisdiction over most of the agencies, institutes and programs of the Department of Health and Human Services, including the Food and Drug Administration. The FDA oversees supplements and is a focal point for the supplement industry. Of the top 20 recipients of money from the nutritional and dietary supplement industry, three members sit on the committee, influencing decision-making. Republicans Mitt Romney (R-Utah), and Tim Scott (R-S.C.) received $16,200 and $11,000 respectively and Democrat Bob Casey (D-Pa.) received $7,050. Romney also received a significant amount, $120,035, during his presidential campaign in 2008, and more, $275,440, in his 2012 campaign.
|Top Members (Includes campaign contributions to presidential campaigns)||Total from industry (1998-2018)|
|Orrin Hatch (R-Utah)||$475,637|
|Mitt Romney (R-Utah)||$412,675|
|Tom Harkin (D-Iowa)||$306,343
|Frank Pallone Jr. (D-N.J.)||$122,850|
|Jason Chaffetz (R-Utah)||$102,259|
|Mia Love (R-Utah)||$90,990|
|Hillary Clinton (D)||$77,536|
|Martin Heinrich (R-N.M.)||$72,000|
|John McCain (R-Ariz.)||$64,850|
|Marsha Blackburn (R-Tenn.)||$62,400|
|Brian Bilbray (R-Calif.)||$54,750|
|Steve Israel (D-N.Y.)||$49,600|
|Dan Burton (R-Ind.)||$48,650|
|Marco Rubio (R-Fla.)||$46,700|
|Mike Lee (R-Utah)||$44,650|
|Ernest Istook (R-Okla.)||$44,000|
|Tony Cardenas (D-Calif.)||$42,469|
|Barack Obama (D)||$42,099|
|Pete Sessions (R-Texas)||$41,950|
|Max Baucus (D-Mont.)||$40,949
Under President Barack Obama, the Federal Trade Commission, which regulates food advertising, sought to crack down on inflated health benefit claims by advocating for heightened clinical trial standards. The Trump administration dropped such efforts. Dr. Scott Gottlieb, Trump’s FDA commissioner until April 2019, is on the record as a proponent of nutritional supplements and the current acting FDA commissioner, Dr. Norman Sharpless, is not expected to change this stance in the same role.
The nutritional and dietary supplement industry is using close industry connections to political players to maintain relative self-regulation as well as address the notion that supplements may have limited health benefits.
In addition to findings in 2018 in the Journal of the American College of Cardiology that there is no conclusive evidence for the benefit of any supplement across all dietary backgrounds, manufacturers are not required to provide explicit instructions on how much to take or on potential drug interactions. There was an overall increase in the rate of dietary supplement exposures reported to poison control centers from 2000 through 2012. Findings such as this encourage the industry to continue to lobby congress.
Having spent a record $63,075 in 2018 election cycle, the Natural Products Association, the largest and oldest trade association for dietary supplements and nutrition, is on track to meet that with contributions of $14,750 to Republicans in the 2020 cycle thus far. The group is focusing lobbying efforts on expanding the Supplemental Nutrition Assistance Program to include nutritional supplements as well as on CBD regulation.
The Council for Responsible Nutrition, another trade association for dietary supplements and functional foods, has long pushed for supplements and nutritional aids to be considered deductible medical expenses under Health Savings Accounts and Flexible Spending Accounts. The council opposes an amendment introduced by Sen. Richard Blumenthal (D-Conn.) to the annual defense budget that would require additional reporting for adverse events that may be associated with dietary supplements. The group is also lobbying for the expansion of SNAP to include multivitamins.
The American Herbal Products Association, a trade group for the herbal and botanical product industry, has no documented contributions in 2020, but in 2018 spent $15,850 with a majority – $9,350 – going to Democrats. The group is an advocate for CBD and cannabis, urging the FDA to create legal access to CBD.
Company heads take the lead
Since 1990, the industry has contributed more than $14 million to federal candidates, and much of this can be attributed to a handful of large companies and their executives.
Michael Schoor, president of Essential Formulas Inc., a company selling probiotics, contributed neary $189,560 in 2016 and nearly $20,050 in 2018, exclusively to Republican candidates and PACs. Keith Frankel, president and CEO at Vitaquest, a nutraceutical and functional foods company, contributed $93,000 in 2016 and $32,000 in 2018.
Herbalife International, a multi-level marketing firm that sells weight loss products and nutritional supplements, contributed a total of $134,621 in 2016 and $236,000 in 2018. The Herbalife International PAC contributed $210,319 since 2016, giving fairly evenly across the aisle.
In 2014, the FTC opened an investigation into Herbalife accusing the company of operating as a pyramid scheme. After the completion of the investigation, Herbalife was fined $200 million, but it stayed in business and eventually made a comeback.
In 2015 in her role as California’s attorney general, Sen. Kamala Harris (R-Calif.), a current 2020 Democratic presidential candidate, was urged by prosecutors in the San Diego office to pursue an investigation into Herbalife. Shortly thereafter, Harris received the first of three donations, totaling $5,400, to her Senate campaign from Heather Podesta, a lobbyist whose ex-husband’s firm, the once-powerful Podesta Group, had worked for Herbalife since 2013. Podesta’s own lobbying firm now lobbies for Herbalife. Harris did not pursue an investigation.
Seizures, like that of the Life Rising Corp. earlier this month, display that regulations in place are being enforced. However, with significant financial resources and legislative support leading into the 2020 elections, the nutritional and dietary supplement industry will likely continue to spread money around Washington to ensure that these regulations aren’t expanded.
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