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Sacramento, CA—California Governor Gavin Newsom has vetoed Assembly Bill 1341. As WholeFoods Magazine has reported, California bill AB-1341: Dietary supplements for weight loss and over-the-counter diet pills called for restricting access to dietary supplements.

Newsom explained in his veto letter that the bill would prohibit retail establishments from selling, transferring, or providing, dietary supplements for weight loss or over-the-counter diet pills to anyone under 18 years of age without a prescription, or valid ID prior to purchasing. AB-1341 also would require the California Department of Public Health (CDPH) to establish a list of dietary supplements that would be subject to such restrictions.

Outlining his reasons for vetoing the bill, Newsom said: “I commend the work of the author as this bill raises an important public health issue related to the safety of diet or weight loss pills that can result in injury. However, dietary supplements for weight loss are not considered drugs and, therefore, this measure would require CDPH to evaluate every individual weight loss and dietary supplement product for safety, which is beyond the scope of the department’s capabilities.”

As future steps, Newson:

• Called for CDPH to form a workgroup including academic and medical experts to develop public policy recommendations on the best way to educate the public health on the topic of supplements for weight loss.
• Noted that CDPH “is prepared to work with the legislature next session to address sales age limits and other potential legislative actions to address the responsible sale of dietary supplements for weight loss and over-the-counter diet pills that do not require the state to undertake lengthy and costly pharmacologica l studies on the many supplements on the market today.”

Industry Responds to News of the Veto

The Natural Products Association (NPA), which has been working to fight the bill and led a grassroots campaign to mobilize industry members, said the veto was “a big win for American consumers, free enterprise, and thousands of small and  large businesses in California.” NPA pointed to the larger impact the bill would have had, explaining that it would have “required brick and mortar retailers to post warning signs at purchase counters saying that dietary supplements are known to cause serious adverse events, including stroke, organ failure, and even death despite no scientific evidence supporting the claim. The bill had no such similar warning requirements for online sales.”

NPA took several actions to fight AB-1314

Actions from NPA include: 

• Sending a letter to Newsom asking that the bill be vetoed.
• Sending letter to the CDPH director urging him to recognize the importance of dietary supplementation and the scientific evidence from the FDA showing there is no correlation between dietary supplement use and eating disorders.
• Testifying against the bill.

“This is a decisive victory for California consumers, the natural products industry and science,” said Daniel Fabricant, Ph.D., NPA President and CEO. “Supporters of this bill like STRIPED used a range of completely false claims and zero science to jam this  through with no evidence, but to his credit Governor Newsom and his team looked at the facts and  made the right call. NPA members had a big hand in persuading him by sending thousands of messages that made their opposition clear. While we are extremely grateful Governor Newsom listened to the science, the fact remains other states need to now take now notice and ensure these draconian policies never again see  the light of day. NPA is still currently battling to ensure similar proposals in New Jersey, New York, Massachusetts, Missouri, and Rhode Island do not become law.”

AHPA & CRN engaged with bill’s sponsor

Also sharing news of the veto, the American Herbal Products Association (AHPA) reported that, over the last two years, they trade group “has worked closely and directly with Assemblymember Cristina Garcia, the bill’s sponsor, to present the interests of consumers and the responsible sports nutrition industry.”

The Council for Responsible Nutrition (CRN) said that while CRN opposed the initial version of AB-1341, the group “engaged with Assemblymember Garcia to reach an amended version that required CDPH to evaluate products individually, rather than imposing a categorical restriction on dietary supplements.” CRN noted that the amended version of the bill “removed liability from retail clerks and eliminated the restricted access to affected products as originally included in the legislation.” When the bill passed the Senate with those changes, CRN removed its opposition and took a neutral position.

Julia Gustafson, CRN Vice President, Government Relations, said, “CRN had multiple conversations and a good working relationship with bill author Assemblymember Cristina Garcia and her staff. We appreciate her willingness to include practical measures in the final version of her legislation that limited its scope and removed behind-the-counter restrictions…We expect this bill or similar proposals to be reconsidered during the next legislative session. CRN stands ready to work with the lawmakers to ensure this legislation is reintroduced in a way that responsibly balances consumer safety with public access to dietary supplements.”

NPA spotlights power of grassroots efforts

Regarding the grassroots campaign designed to counter AB-1314 (in addition to opposing  similar proposals in New York, New Jersey, Massachusetts, Missouri, and Rhode Island), NPA’s Dr. Fabricant said, “This is a prime example of what a strong grassroots network can do for the industry. NPA’s grassroots network sent over ten thousand emails and phone calls to Governor Newsom and the legislature urging their opposition to AB-1341.”

Related: COSMOS-Mind Study Shows Promise for Multivitamins in Cognition

 

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Washington, D.C.—On the eve of the White House Conference on Hunger, Nutrition, and Health, which takes place September 28, 2022, the Council for Responsible Nutrition (CRN) is urging Conference leaders in the Biden Administration to focus on closing nutrition gaps. The conference aims to end hunger and increase healthier outcomes by 2030, and CRN stressed that addressing nutrition gaps is an important component in striving for a healthy and well-nourished America.

In a letter submitted to the conference leaders, CRN President and CEO Steve Mister and Andrea Wong, Ph.D., Senior Vice President, Scientific and Regulatory Affairs, emphasized that the Conference should address improvements to nutrition along with physical hunger. Mister stated: “No one should have to go to bed hungry, and everyone should have access to a variety of food that provides a sense of satiety, but focusing solely on calories and food quantity would be shortsighted. Better nutrition leads to healthier lives. Public policy should consider how to increase intake of essential nutrients among all socioeconomic groups and to address nutrition disparities that lead to chronic disease and missed opportunities to reduce these illnesses.”

Related: NPA Stresses Value of Supplements to White House Conference on Hunger, Nutrition, and Health

In July, CRN submitted recommendations to the White House Conference to increase nutrition access and now has reiterated its earlier calls for attention to better nutrition as well as reducing hunger.

As outlined in July, CRN recommends the following to help achieve the Conference’s proposed pillars:

Include multivitamins/mineral supplements in the Supplemental Nutrition Assistance Plan (SNAP) benefits.

CRN pointed to existing research that shows low-income and food-insecure adults are at greater risk of nutrient shortfalls. Amending the SNAP program to allow beneficiaries the opportunity to purchase multivitamin/mineral supplements would help address the socioeconomic nutritional gap and help achieve improved food access and affordability, CRN said.

Allocate adequate resources to regularly update Dietary Reference Intakes (DRI) and establish new DRIs for nutrients & bioactives as needed.

CRN noted that, with a few exceptions, DRIs have not been updated for at least the past 15 to 20 years despite research that highlights the role of nutrition in strengthening immunity, maintaining cognitive function and active lifestyles, and reducing chronic disease risk. CRN called for regular updates to existing DRIs, and establishing new ones, to integrate nutrition and health by giving researchers, policy makers, and healthcare providers up-to-date information on nutrients and bioactives in order to develop new programs and recommendations.

Develop initiatives to educate on the relationship between nutrition & better health, and the role supplements can play in filling nutrient gaps.

CRN noted that, addition to access to a variety of nutritious foods that deliver these nutrients, and supplements to fill in nutritional gaps, consumers need access to nutrition education that explains the importance of eating a healthy diet and explains the negative health consequences from failing to meet the body’s nutritional needs.

Grant attention to private sector initiatives/partnerships to increase nutrition access.

CRN highlighted private sector initiatives to improve nutrition access by working with non-profits that serve low-income and food-insecure people. To broaden the supplement industry’s efforts, CRN said its Act for Access program challenged its members to volunteer or donate to non-profits between June and September, and has demonstrated success with broad participation from members.

Related: CRN’s Feedback on FDA’s Supplement Your Knowledge Content
COSMOS-Mind Study Shows Promise for Multivitamins in Cognition
“Not the Final Word”—CRN Responds to Reporting on 2 Vitamin D & COVID-19 Studies

 

 

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On August 24, 2022, Kaiser Health News (KHN) reported that Lori McClintock, the wife of U.S. Rep. Tom McClintock of Northern California, died at the age of 61 late in 2021 “after ingesting a plant that is generally considered safe and is used as an herbal remedy for a variety of ailments, including diabetes, obesity, and high cholesterol.” KHN’s headline: “Congressman’s Wife Died After Taking Herbal Remedy Marketed for Diabetes and Weight Loss.”

The Sacramento County coroner reported that Lori McClintock died from dehydration due to gastroenteritis that was caused by “adverse effects of white mulberry leaf ingestion.”

In the days that followed, mainstream media ran with the story with headlines such as “Wife of U.S. Congressman died ‘accidentally’ after using white mulberry leaf supplement” and “How Did Herbal Remedy Kill Lori McClintock?” Various articles cast doubt on the benefits and safety of dietary supplements, calling them “poorly regulated” and maintaining  that supplements “in some cases, can actively be harmful.”

Daniel Fabricant, Ph.D., CEO and President of the Natural Products Association (NPA), commented in the KHN report, questioning the coroner’s finding. “It’s completely speculative,” Dr. Fabricant stated. “There’s a science to this. It’s not just what a coroner feels. People unfortunately pass from dehydration every day, and there’s a lot of different reasons and a lot of different causes.”

Experts Weigh in on Findings of Mulberry Leaf

“The widely disseminated report of a death caused by ingesting a supplement containing Mulberry leaf is an example of a coroner jumping to conclusions that he was not qualified to make, and then the media sensationalizing and demonizing ‘another deadly herb’ without much if any proof,” maintains David Winston RH(AHG) founder and President Herbalist & Alchemist. “The coroner stated he identified a partially digested Mulberry leaf in the woman’s stomach.  This is problematic for two reasons.  First, is he a botanist or did he have a DNA lab positively identify the leaf as Mulberry? Secondly, if the woman was taking a supplement (capsule, tablet, tincture, extract granule) or a tea, there would not be any identifiable leaf in her stomach.  Was she eating fresh or dried Mulberry leaves?  If so, this is not a supplement.”  

Elan Sudberg, CEO, Alkemist Labs, further breaks down the coroner’s findings and points to “peculiarities” he is considering after reading the certificate of death. Sudberg’s breakdown:

1. “Eating an entire leaf is an unusual delivery mechanism outside of the norm for dietary supplements.”
2. “As a botanical microscopist, I wonder who identified the leaf, and how. If you were to send me a sample of a leaf recovered from the stomach of a deceased person, it would be hard to pinpoint a particular botanical unless a tip (look for herbs used in diets) was provided. There are many plants traded in our industry. My company tests nearly 2,000 of them. Without a suggestion, it would take a very long time to cross reference all of them to get to Morus alba. AND when it was found, was it really in good enough shape after being partially digested and aging in a deceased person’s stomach? I believe they had a suspicion and reason to find a culprit.”
3. “Was the leaf material or Mrs. McClintock tested for APIs (Active pharmaceutical ingredients like sibutramine) that may have contraindications for other drugs she was taking? Per the toxicology report, there is no data on to show that those very important tests were conducted.”
4. “What else was she self-administering? Where is the toxicology report showing the pharmaceuticals that were also in her system? The data is not adding up and someone is not being transparent. “

Mulberry Leaf has a Long History of Safe Use

“As I read into the details that were available, I began to question the accuracy of the conclusion that the medicinal herb, Morus alba, with centuries of recorded use/real-time safety data, that has shown no risk nor history of illness from this botanical, was the killer,” says Sudberg. “The American Herbal Products Association’s Botanical Safety Handbook states that Morus alba leaf has a safety rating of 1 and an interaction of A, which indicates no reports of known adverse effects in reviewing the literature up until 2013 and no knowledge of such adverse effects. One of the most comprehensive English language materia medicas available, Chinese Herbal Medicine by Bensky et al. (3rd edition), list no cautions or contraindications with mulberry leaf use.” 

Mulberry leaf tea has been used safely for millennia in China and the fresh leavers are used as animal fodder, Winston adds. ”The woman’s blood work suggests severe dehydration. Mulberry leaf, while having hypoglycemic activity, is not known to have diuretic activity based on traditional Chinese usage or modern research.  So, is this an issue of [supplement] quality control or lack of testing? Doubtful.  Is it even likely that her death was caused by Mulberry? The evidence for causality is simply not there.” 

Transparency is Key for Supplements

“Events like this, regardless of the level of scandal behind them, do damage to our beloved industry,” Sudberg says. “It hurts all the brands. Even the ones doing all the right work and spending endless amounts of money testing six ways until Sunday. We remedy this scar on our industry with transparency. It is high time our industry stood up to show its quality leaving the brands that can’t, sitting down for good. Much of the world thinks we are unregulated. We are not unregulated but how would the world know if we don’t talk about our above and beyond regulatory compliance quality? On the rare occasion, I agree with Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance, on dietary supplements; it’s important to try to find supplements that a third-party has certified. You have to do your homework. Let’s as an industry make it easy for consumers to do their homework by proudly displaying the quality that holds up our industry.” 

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
CRN calls Vitamin D VITAL for Health Study a “Disservice to Americans Seeking Better Health”

 

NOTE: This article may be updated as more information becomes available.

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