The allure of a "magic bullet" for weight loss has driven many to explore over-the-counter dietary supplements. These supplements, readily available and often promising remarkable results, appeal to those seeking an easier path than diet and exercise. However, understanding the ingredients, efficacy, and safety of these supplements is crucial for making informed decisions. This article delves into the world of slimming botanical diet pills, examining their ingredients, potential benefits, and associated risks, while making maximum use of the information provided by the user.
The Appeal and Regulation of Weight-Loss Supplements
Many patients desire a "magic bullet” for weight loss. OTC weight-loss supplements appeal to many patients who desire a “magic bullet” for weight loss.A multi-state survey in 1998 found that 7 percent of adults used OTC weight-loss supplements, with the greatest use noted among young obese women (28 percent). These supplements appeal to the desire for a "magic bullet" that is less demanding than special diets and increased physical activity. They are available without a prescription and often advertise remarkable benefits.
In the United States, dietary supplements are regulated by the Food and Drug Administration (FDA). Regulations mandate that all ingredients used to manufacture dietary supplements be tested for identity and be free from reasonably anticipated contaminants. However, the FDA does not require manufacturers to provide proof of safety and efficacy before marketing supplements. Furthermore, adoption of good manufacturing practices by supplement makers is not currently mandatory. Despite these regulations, misbranded dietary supplements are frequently found to contain potentially dangerous substances.
Dangerous Substitutions and Adulterations
Recent incidents have highlighted the dangers of mislabeling and adulteration in the supplement industry. The FDA is advising consumers to stop using Nut Diet Max brand (seeds or capsules) or Todorganic Natural brand (seeds) products marketed as Nuez de la India, India nuts, or India seeds because they may contain yellow oleander.
Yellow Oleander: A Recurring Threat
Ingestion of yellow oleander can cause neurologic, gastrointestinal and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.
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Nuez de la India is marketed as India nuts or seeds, which are generally understood to be nuts from the flowering tree Aleurites moluccanus, or commonly known as candlenut, candleberry, Indian walnut, kemiri, and varnish tree. Additional analyses by MDH and FDA revealed that the Nut Diet Max and Todorganic seed products contained cardiac glycosides and other characteristics consistent with yellow oleander, and not nuts from the Aleurites moluccanus plant. Additional analysis found Nut Diet Max brand Nuez de la India capsules contained cardiac glycosides consistent with yellow oleander. The Agency is also concerned that other products with similar marketing descriptions may also contain yellow oleander.
On September 6, 2023 OBC Group Corp, located in Miami, FL , issued a press release indicating that they initiated a voluntary recall of its Nut Diet Max brand Nuez de la India capsule and seed products, labeled as being distributed by Natural Vida of Miami, FL, after FDA analyses determined that the products appeared to be yellow oleander. The product NUEZ DE LA INDIA Seeds was distributed online through Amazon and eBay. The Seeds comes in a 2-ounce clear bag. The product NUEZ DE LA INDIA Capsules was distributed online through Walmart and eBay. The Capsule product comes in an amber bottle with 30 capsules. Both the seed and capsule products are labeled as being distributed by Natural Vida of Miami, FL.
Consumers who purchased Nuez de la India seeds and capsules products with the brand NUT DIET MAX are urged not to consume the products and to return them to the place of purchase for a full refund. The product was distributed online through the Amazon, eBay, and Walmart platforms. Consumers who purchased Nuez de la India seeds from TODORGANIC INC are urged to return it to the place of purchase for a full refund. The FDA’s investigation is ongoing, and FDA will continue to provide information on any further actions as it becomes available. Products may be added to this advisory.
Tejocote Root and Yellow Oleander
Tejocote (Crataegus mexicana) root, a supplement promoted online through social media for weight loss, is readily available from online retailers. Recent DNA fingerprinting of a product labeled as containing tejocote root under the brand name Alipotec determined that the product was 100% yellow oleander (Cascabela thevetia).
On September 8, 2022, an emergency physician called the New Jersey Poison Information and Education System (NJPIES) regarding a child aged 23 months who had consumed Eva Nutrition Mexican Tejocote Root and developed nausea and vomiting. The product was marketed as a weight loss supplement and purchased by the patient’s mother. The patient was experiencing age-specific bradycardia (heart rate = 90 bpm; normal range = 98-135 bpm) and was hypotensive (blood pressure = 71/60 mm Hg). Electrocardiogram (ECG) results demonstrated sinus bradycardia, frequent premature ventricular complexes, and scooped ST segments consistent with cardenolide toxicity.
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At the direction of NJPIES, a serum digoxin assay was obtained with a reported level of 0.5 ng/L, which NJPIES interpreted as being attributable to cross-reactivity with a nondigoxin cardiac glycoside. After receiving treatment with 40 mg of digoxin-specific antibody fragments (FAB, a digoxin overdose antidote), the patient’s ECG and blood pressure normalized. A repeat ECG 12 hours later again demonstrated evidence of cardenolide toxicity.
Because of the public health concerns of this likely mislabeled product, 10 products labeled as tejocote and marketed as weight loss supplements were purchased by NJPIES online during December 2022. Each product was listed on a separate page, although some carried the same or similar labels. Products were shipped directly to Flora Research Laboratories (Grants Pass, Oregon), which specializes in the analysis of chemical constituents found in dietary supplements. Using ultra-high pressure liquid chromatography-accurate mass-time of flight mass spectrometry analysis, researchers compared the purchased supplements with authenticated tejocote root procured and authenticated results with an ethnobotanist (Trish Flaster, Botanical Liaisons, personal communication, December 2022).
These readily available dietary supplements, upon testing, appeared to be mislabeled. Instead, they contained a toxic substance of concern to both clinicians and public health officials. FDA recently released a consumer warning about toxic yellow oleander purported to be Nuez de la India in certain botanical weight loss products.
Clinicians need to be aware that persons with signs and symptoms of cardiac glycoside exposure might have been exposed to products labeled as tejocote, Nuez de la India, or other supplements marketed for weight loss and might benefit from treatment with a similar approach to that used in cases of nondigoxin cardiac glycoside exposures. Persons who are exposed to yellow oleander with evidence of toxicity might have a positive serum digoxin result on immune assays caused by cross-reactivity and might respond to FAB, as did the patient in this report. However, higher doses of FAB might be required for the reversal of yellow oleander toxicity than that typically used in cases of digoxin toxicity. Serum digoxin assays are not reliable for detection of thevetin B and cardiac glycosides other than digoxin. Laboratory-reported digoxin levels do not accurately reflect serum levels of other cardiac glycosides.
For public health officials, this is concerning because these supplements contain a highly toxic substance and are readily available from multiple retailers. Future prevention efforts need to include reporting products such as these to FDA and alerting retailers who might be unknowingly selling these hazardous products.
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Specific Botanical Ingredients and Their Efficacy
More than 50 individual dietary supplements and 125 proprietary products are listed in the Natural Medicines Comprehensive Database as commonly being used for weight loss. Individual supplements found in at least five commercial products are discussed in this review, according to their purported mechanism of action.
Ephedra (Ma Huang) and Other Sympathomimetic Amines
Ephedra sinica (or Ma huang in Chinese) is a shrub native to China and Mongolia that contains sympathomimetic compounds referred to as ephedra alkaloids. Bitter orange and country mallow contain related chemicals. Ephedra alkaloids commonly are combined with caffeine or botanical sources of caffeine (e.g., guarana, yerba maté) for weight loss.
The Chinese botanical ephedra, or ma-huang, is sold as a dietary supplement in the United States. It is a natural source of the alkaloids ephedrine and pseudoephedrine. Synthetic ephedrine and pseudoephedrine are found in over-the-counter decongestants and cold medicines and are used to treat asthma. The use of ephedrine, ephedrine plus caffeine, or dietary supplements containing ephedra and botanicals with caffeine is associated with a modest but statistically significant increase in weight loss over a relatively short time (less than or equal to 6 months).
Ephedra is the common name for three principal species: Ephedra sinica, Ephedra equisentina, and Ephedra intermedia. Alkaloid content and composition vary by species and growth conditions; total alkaloid content can vary from 0.5% to 2.3%. Ephedrine, the most potent alkaloid, can account for up to 90% of the total alkaloid content and pseudoephedrine can account for up to 27%. The pharmacologic activity of an ephedra sample depends on its alkaloid composition. North American ephedra species, such as E.
Ephedrine is a mixed sympathomimetic agent that enhances the release of norepinephrine from sympathetic neurons and stimulates alpha and beta receptors. Ephedrine stimulates heart rate, thereby increasing cardiac output. It causes peripheral constriction resulting in an increase in peripheral resistance that can lead to a sustained rise in blood pressure. Ephedrine acts as a stimulant in the central nervous system. Of the ephedra alkaloids, ephedrine is the most potent thermogenic agent.
A recent meta-analysis of RCTs showed a weight loss of 0.9 kg (2 lb) more per month for ephedra-containing supplements compared with placebo. Using adverse event data from 50 trials of ephedra, a 2.2- to 3.6-fold increase in the odds of psychiatric, autonomic, cardiovascular, and gastrointestinal symptoms was estimated. Another review of adverse events possibly associated with ephedra use included 87 reports to the FDA MedWatch program between June 1997 and March 1999. These reports included episodes of hypertension, arrhythmias, myocardial infarction, stroke, and seizures. Ten events led to death and 13 yielded permanent disability.
Due to these serious safety concerns, the FDA moved to ban the sale of products containing ephedra.
Chromium
Chromium deficiency is associated with hyperglycemia, hyperinsulinemia, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol. Most weight-loss supplements use chromium picolinate in daily dosages of 200 to 400 mcg. The results of three RCTs that studied the role of chromium in obesity did not show any differences in weight loss between the treatment and placebo groups. However, drawing conclusions from these studies is difficult because of their small size (n = 15 to 36).
Fiber Supplements: Guar Gum and Glucomannan
Numerous weight-loss products contain sources of soluble fiber, which theoretically could absorb water within the gut, causing increased satiety and lower caloric intake. Fiber also may improve control of diabetes and hyperlipidemia, two common comorbidities in patients with obesity.
Although guar gum is relatively safe, a meta-analysis of 11 RCTs of guar gum versus placebo for weight loss showed no benefit. Three RCTs suggest that glucomannan in dosages of 3 to 4 g per day may be well tolerated and yield modest weight loss. However, these trials were small (n = 20 to 50) and had methodologic limitations.
Hydroxycitric Acid (HCA)
Hydroxycitric acid (HCA) is derived from the Malabar tamarind tropical fruit (Garcinia cambogia) native to India. HCA has been found to inhibit mitochondrial citrate lyase, leading to decreased acetyl coenzyme A production and decreased fatty acid synthesis.
A 12-week RCT of mildly overweight women (n = 89; mean BMI of 28.6 kg per m2) reported a 1.3 kg (2 lb, 14 oz) greater weight loss in women who received 750 mg of HCA per day versus placebo. In contrast, an RCT comparing a different formulation of HCA at 1,500 mg per day and placebo in 135 men and women with a higher average BMI (31.2 kg per m2) showed no differences in BMI or adverse events.
Conjugated Linoleic Acid (CLA)
Conjugated linoleic acid (CLA) refers to a family of trans-fatty acids that have been found to reduce fat deposition in obese mice, possibly through increased fat oxidation and decreased triglyceride uptake in adipose tissue.
A 12-week RCT of 60 patients using 3.4 to 6.8 g per day of CLA reported no change in BMI. Persons taking CLA reported mild to moderate gastrointestinal symptoms.
Green Tea, Licorice, and Pyruvate
In one study, green tea increased fat oxidation and thermogenesis in 10 patients, but the study was not designed to assess weight loss. Licorice reduced body fat mass without changing BMI in 15 persons of normal weight. However, licorice has been reported to cause pseudoaldosteronism, hypertension, and hypokalemia. Six weeks of pyruvate, in a dosage of 6 g per day, was associated with a weight loss of 1.2 kg (2 lb, 10 oz), compared with placebo. Although vitamin B5 has been postulated to cause weight loss, no human trials support this.
Chitosan
Chitosan, derived from chitin found in crustacean shells, is a positively charged polymer thought to prevent fat absorption by binding negatively charged fat molecules within the intestinal lumen. A meta-analysis of five RCTs that evaluated chitosan and placebo for weight loss showed a greater mean weight reduction for chitosan (3.3 kg [7 lb, 4 oz]) over placebo. Subsequently, three other researchers reported well-designed RCTs that failed to show any differences in weight loss.
Other Botanical Remedies
Dandelion (Taraxacum officinale) appears to have diuretic activity and cascara (Rhamnus purshiana) acts as a laxative. Neither of these herbs has been studied specifically for weight loss in humans. Although botanical remedies for depression such as St. John’s wort (Hypericum perforatum) often are found in weight-loss products, no data support their role in weight loss. Laminaria (kelp) has not been studied for weight loss. Spirulina (also known as blue-green algae) contains phenylalanine, which is purported to inhibit appetite. In 1981, the FDA declared spirulina ineffective for weight loss, and no subsequent studies to the contrary have been published.
Recommendations for Physicians and Consumers
Criteria adapted from a recent review can be used to develop clinical recommendations for each supplement. If there is strong evidence for a product’s quality, safety, and efficacy, it may be reasonable to recommend that product and closely monitor the patient. No supplements discussed in this review meet these criteria, however. In contrast, it would be appropriate to discourage use of products when there is strong evidence for lack of quality, safety, or efficacy. For example, use of products that contain ephedra should be actively discouraged because of serious safety concerns. Chitosan appears to be ineffective for weight loss and should also be discouraged. The use of guar gum for weight loss should be discouraged because of its lack of efficacy.
For products that do not fall into the categories to recommend or to discourage use because of insufficient or contradictory evidence, physicians should caution their patients about the risks and benefits of using the product given the uncertainty in safety, efficacy, and/or quality control. Chromium, CLA, ginseng, glucomannan, green tea, HCA,l-carnitine, psyllium, pyruvate, and St. John’s wort fall into this category.
Patients who use weight-loss supplements may be highly motivated to lose weight, and physicians can try to harness this motivation to encourage more proactive and established approaches to weight loss, such as changes in diet and exercise.
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