FDA Expands Warning to Consumers About Product That Has Been Referred to as “Nature’s Ozempic”

There are currently three FDA-approved semaglutide products. All three medications, Ozempic, Rybelsus, and Wegovy, are only available with a prescription, and there are no approved generic versions. Since their approval, many weight loss products have used the medications’ name, “Nature’s Ozempic”, etc. to fuel sales of their products.

Per the FDA: The FDA and Maryland Department of Health analyses have determined that certain weight loss products labeled as Nuez de la India, and potentially marketed as “botanical food,” “India Nuts for Weight Loss,” “slimming seeds,” “India seeds for weight loss,” or “diet seeds,” appear to be highly toxic yellow oleander, a poisonous plant native to Mexico and Central America. 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.

• One person in the state of Maryland is known to have been hospitalized after consuming Nut Diet Max brand Nuez de la India seeds.
• These products are typically sold online through third-party platforms (e.g., Amazon, Walmart, eBay)

Tested Products

• Botanical weight loss products, both in seed and capsule form, sampled and determined by the FDA to be substituted with yellow oleander.

Below are pictures of the sampled seeds labeled as Nuez de la India with comparisons to authentic Nuez de la India or candlenut seeds and authentic yellow oleander seeds.

Nut Diet Max Brand: Image shows authentic seeds on the left compared to sampled seeds on the right.

Todorganic Brand: Image shows authentic seeds on the left compared with sampled seeds on the right.

Recommendations for consumers

• 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. For other Nuez de la India, India nuts, or India seeds products, FDA urges customers to exercise caution because of the similar physical appearance between candlenut seeds (which are non-toxic) and highly toxic yellow oleander seeds.
• The FDA advises consumers who have taken any of these products of concern to contact their health care provider immediately.  Even if these products have not been used recently, consumers should still inform their health care provider about which product they took, so that an appropriate evaluation may be conducted.
• Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products.
• Contact your healthcare provider if you or someone in your care recently ingested these products or other botanical weight loss products and have health concerns.
• Consumers can also contact the state poison control center.

Summary and Scope of the Problem

Recently, the Maryland Department of Health (MDH) began sampling and testing weight loss products labeled as Nuez de la India after one person in the state reported the consumption of a Nuez de la India product and was hospitalized. 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. Based on these analyses, the Agency determined that the product appeared to be yellow oleander, and not Nuez de la India.

Additional analysis found Nut Diet Max brand Nuez de la India capsules contained cardiac glycosides consistent with yellow oleander. The FDA has expanded its safety alert to include this product.

The Agency is also concerned that other products with similar marketing descriptions may also contain yellow oleander. Consuming yellow oleander can cause severe adverse health effects and be potentially fatal.

Actions

The US Food & Drug Administration (FDA) is actively working with the third-party platforms where these products are sold.

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. Additional recall information is available in the firm’s press release (also available in Spanish).

Additionally, on August 30, 2023, the manufacturer TODORGANIC INC., located in Middleburg FL, issued a press release indicating that they initiated a voluntary recall of its Nuez de la India Seeds after FDA analysis determined that the seeds appeared to be yellow oleander. 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. Additional recall information is available in the firm’s press release (also available in Spanish).

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. FDA is working with federal and state partners to further address the concerns related to these products and monitoring the market for adverse events, product complaints, and other emerging issues.