Natural Treatment Reduces Risk of Diabetes by 41%, Encounters Hurdles for FDA Approval in the US

June 17, 2024 TruthUSA

The FDA suggests that “If a supplement promises a cure or quick fix for a health problem, it is probably too good to be true.”

Diabetes is reaching epidemic proportions, with millions of people developing the disease each year. “Safe and effective treatments for preventing type 2 diabetes in persons at high risk for the disease are needed,” wrote Dr. Mitchell Katz, president and chief executive officer of New York City Health and Hospitals in an editor’s note in JAMA Internal Medicine on June 3.

What if effective treatments exist, but we lack access to them? A new study from China suggests that Jinlida granules, a traditional Chinese herbal medicine, could significantly reduce the risk of diabetes. However, regulatory hurdles make it difficult for such treatments to gain approval and become widely available in the United States.

The Study

The study, published in JAMA Internal Medicine shows that Jinlida, a treatment approved for Type 2 diabetes in China composed of 17 herbal ingredients, reduces the risk of developing diabetes in individuals with impaired glucose tolerance (IGT). This condition involves elevated blood sugar levels that have not yet reached the threshold for a diabetes diagnosis. Participants taking Jinlida experienced a 41 percent lower risk of developing diabetes compared to those receiving a placebo.

The study involved 885 participants aged 18 to 70, monitored over two years. All participants engaged in a comprehensive lifestyle intervention program, including monthly physical activity sessions, dietary adjustments, and other lifestyle modifications. They also received a booklet with recommendations for daily habits, such as regular physical activity, regulating protein and carbohydrate intake, increasing dietary fiber, and reducing sodium consumption.

One group took 9 grams of Jinlida granules three times daily, while the other group received a placebo. This approach enabled researchers to assess the effectiveness of Jinlida granules alongside lifestyle interventions in preventing diabetes and managing related health conditions.

“To our knowledge, our study was the first to investigate the synergistic effects of traditional Chinese medicine (TCM) and lifestyle modifications among participants with IGT, abdominal obesity, and metabolic disorders,” the researchers noted, highlighting the combination of TCM with conventional preventive strategies.

Results showed that individuals in the Jinlida group had a lower incidence of diabetes and demonstrated improvements in waist size, body mass index, and cholesterol levels. Significant decreases were noted in both after-meal and fasting blood sugar levels and HbA1c, a measure of long-term blood glucose control. Jinlida was also linked to better cholesterol profiles, with reductions in bad cholesterol and triglycerides and an increase in good cholesterol.

Herbal Treatments vs. Medications

In the United States, herbal treatments and medications face different regulatory standards. Medications must undergo rigorous testing for safety and effectiveness to receive approval from the U.S. Food and Drug Administration (FDA), whereas herbal treatments are usually marketed as dietary supplements. “The FDA considers herbal supplements as foods, not medicines,” according to Johns Hopkins Medicine.

“New herbal supplements and products are not governed by the strict FDA drug approval process, and there is no premarket approval required,” writes Christopher Ty Williams, associate professor of nursing at Vanderbilt University, in a 2021 review. According to the editor’s note in JAMA, companies only need to notify the FDA of their belief in the supplement’s safety before it hits the market.

Herbal products cannot claim to address specific diseases unless they meet stringent FDA drug approval guidelines. “Products that have claims to treat, diagnose, prevent, or cure diseases are generally subject to regulation as drugs,” the FDA website states. “If a supplement promises a cure or quick fix for a health problem, it is probably too good to be true.”

This regulatory gap means that even when herbal products like Jinlida granules show promising results and strong safety profiles in clinical trials, they still face significant hurdles to be recognized on par with pharmaceutical drugs.

From Herbal Remedies to FDA Hurdles

The journey to approval by the FDA for herbal treatments involves significant regulatory barriers. “Were this a pill, there would be questions about what stage it was at in the US Food and Drug Administration approval process,” notes Dr. Katz in the editor’s note.

For herbal formulas to win FDA approval, manufacturers must demonstrate consistent composition and dosage in addition to proving effectiveness and safety. This is particularly challenging for botanical products like Jinlida, which Dr. Katz states can vary depending on growing conditions and possess complex chemical profiles.

Even if herbal companies prove safety and efficacy, the cost would be prohibitive for many smaller companies. The 2024 application fee alone for requesting new drug approval from the FDA is over $4 million, a sharp increase from the $3.2 million fee in 2023.

Despite the recent trial’s positive outcome in lowering the risk of developing diabetes, licensed medical professionals such as doctors will not be able to prescribe the herbal formula since it is not FDA-approved. However, consumers may still obtain similar formulas from traditional Chinese medicine practitioners or herbalists.

“As Editors of JAMA Internal Medicine, we want to be open to treatments other than pharmaceuticals, yet we recognize that the barriers for herbal treatments may preclude their being approved as medications,” Dr. Katz said.

This illustrates a broader issue with the U.S. drug approval system. The stringent requirements designed to ensure the safety and efficacy of pharmaceuticals may unintentionally prevent potentially beneficial treatments from reaching the market, particularly those derived from traditional medicine.

Source link