Milly Gaines
TruVision Health LLC, a wellness brand that sells dietary supplements, has been the subject of regulatory scrutiny and consumer reviews. In 2017, the FDA cited serious violations of Good Manufacturing Practice, including issues with product labels and quality control. TruVision was also required to recall certain products in 2023 due to the presence of potentially dangerous and unapproved ingredients, namely hordenine and octodrine/DMHA. These compounds may cause adverse side effects, particularly in sensitive populations. While some consumers have reported positive weight loss results and increased energy, others have experienced negative side effects, including lightheadedness, thirst, nausea, and more. The efficacy and safety of TruVision's products remain a subject of debate, with concerns about their ingredients and manufacturing practices.
| Characteristics | Values |
|---|---|
| Company name | TruVision Health LLC |
| Brand name | Truvy |
| Product | Dietary supplement |
| Product type | Metabolism pills, weight loss supplements |
| Product claims | Can balance out the body's chemistry, boost metabolism, suppress appetite, enhance mood |
| Product format | Two-pill regimen |
| Side effects | Lightheadedness, thirst, sweating, nausea, jitteriness, nervousness, insomnia, chest pain, chills, diarrhea, dizziness, fatigue, headache, high blood pressure, high heart rate, nausea, vomiting, rash, stomach pain, upset stomach |
| Product rating | 4.5/5 stars on Facebook, 3.05/5 stars on Better Business Bureau |
| FDA warning | Yes, for serious violations of Good Manufacturing Practice and for the presence of potentially dangerous ingredients |
| Recall | Yes, in 2023 |
| Refund | Yes, full refund for recalled products |
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What You'll Learn
- TruVision Health recalled their dietary supplement products due to possible health risks
- TruVision's products contained unapproved dietary ingredients
- TruVision's products have been reviewed by customers
- TruVision's manufacturing facility was inspected by the FDA in 2017
- TruVision's products were recalled due to mislabelling
TruVision Health recalled their dietary supplement products due to possible health risks
On April 27, 2023, TruVision Health LLC recalled a list of dietary supplement products due to the presence of unapproved dietary ingredients. The products in question contain hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine), which are considered "possibly unsafe" by the FDA and are not permitted to be sold as dietary supplements.
Hordenine may be unsafe when taken orally and could stimulate side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting, or insomnia. These adverse effects are more likely to occur in sensitive sub-populations, such as pregnant women and individuals with cardiovascular disease. Octodrine or DMHA is similar to another stimulant, dimethylamylamine (DMAA), which was removed from the market in certain countries due to safety concerns. There is no data on its metabolic pathway in humans, and its use during exercise is potentially dangerous. DMHA is also considered an unsafe food additive.
Some consumers who have used these products have reported experiencing chest pain, chills, diarrhea, dizziness, fatigue, headache, high blood pressure, high heart rate, jitters, nausea, nervousness, rash, stomach pain, sweating, and vomiting. These products were packaged as capsules in blister packs and cardboard cartons or as stick packs in 30-count bags. The product bears the TruVision Health or Truvy brand name and was sold online at Truvy.com to customers in the USA, Canada, New Zealand, Germany, Australia, Ireland, and England.
Consumers who have purchased these products should immediately stop using them and are urged to return them to TruVision Health LLC for a full refund (excluding return shipping), an exchange, or they may discard the product. For any questions or concerns, customers can contact Truvy Customer Support at (855) 213-8788, Monday through Friday, 7:00 am-6:00 pm MDT.
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TruVision's products contained unapproved dietary ingredients
TruVision Health LLC recalled its dietary supplement products due to the presence of unapproved dietary ingredients. The company announced the recall on April 27, 2023, citing the potential presence of hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine) in the products.
Hordenine, an unapproved dietary ingredient, may be unsafe when consumed orally and can cause adverse side effects such as an increased heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting, and insomnia. These side effects are more likely to occur in sensitive individuals, such as pregnant women and those with cardiovascular disease.
Octodrine or DMHA is another unapproved dietary ingredient that is structurally similar to dimethylamylamine (DMAA), a stimulant removed from the market in several countries due to safety concerns. Octodrine has been found to increase heart rate, myocardial contractility, and pain threshold in animal studies. The lack of data on its metabolic pathway in humans makes the use of octodrine during exercise potentially dangerous.
The recalled TruVision products were sold online at Truvy.com to customers in the USA, Canada, New Zealand, Germany, Australia, Ireland, and England. They were packaged as capsules in blister packs, cardboard cartons, or stick packs in 30-count bags. Consumers who purchased these products are urged to stop using them immediately and return them to TruVision Health for a full refund, exchange, or discard. The company advised consumers that they would need to cover the cost of return shipping.
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TruVision's products have been reviewed by customers
TruVision Health has received mixed reviews from customers. While some customers have praised the company's products for their effectiveness in weight loss and improved overall health, others have raised concerns about the safety of certain ingredients in their dietary supplements.
On the one hand, TruVision's health and wellness products have garnered positive feedback from individuals who have successfully lost weight and experienced improved energy levels, mental clarity, and overall well-being while using them. For example, some customers have reported losing a significant amount of weight, such as 70 pounds or even over 120 pounds, while taking TruVision's products. They attribute their success to the company's weight management supplements, such as truFIX®, ALTER™, and Trim, claiming that these products have helped reduce bloating, increase energy, and improve mental focus.
Additionally, TruVision offers a 7-Day Experience Kit, allowing customers to try their products before committing to a purchase. This kit has been well-received by those who appreciate the opportunity to experience the products firsthand before making a decision.
On the other hand, TruVision Health has faced scrutiny and issued a recall for certain dietary supplement products due to the presence of potentially dangerous and unapproved ingredients. The recalled products contained hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine), which are considered "possibly unsafe" by the FDA. Hordenine, when taken orally, may cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, and insomnia. Octodrine, also known as DMHA, has been found to increase heart rate and is not approved as a dietary ingredient. Some consumers who used these recalled products experienced adverse effects, including chest pain, chills, diarrhea, dizziness, fatigue, headache, high blood pressure, high heart rate, nausea, and vomiting.
As a result of these concerns, TruVision Health urged consumers to stop using the affected products immediately and offered full refunds or exchanges. The recall highlights the importance of conducting thorough research and consulting with healthcare professionals before taking any dietary supplements to ensure their safety and effectiveness.
Overall, while some customers have had positive experiences with TruVision's products, the presence of potentially unsafe ingredients in certain supplements raises concerns about their safety profile. It is always advisable to consult with a healthcare professional before starting any new dietary supplement regimen to ensure it is safe and appropriate for your individual needs.
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TruVision's manufacturing facility was inspected by the FDA in 2017
The U.S. Food and Drug Administration (FDA) conducted an inspection of TruVision's manufacturing facility in Draper, Utah, from May 15 to May 31, 2017. The inspection revealed serious violations of the FDA's Current Good Manufacturing Practice (CGMP) in manufacturing, packaging, labelling, and holding operations for dietary supplements.
The FDA's inspection found that TruVision's dietary supplement products were adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. The products had been prepared, packed, or held under conditions that did not meet the CGMP requirements for dietary supplements. In addition, the inspection found issues with the product labels and the website.
As a result of the inspection, the FDA issued a warning letter to TruVision Health LLC on November 29, 2017, detailing the violations and requiring corrective actions. The letter stated that TruVision, as a responsible official of a facility that manufactures, processes, packs, or holds food for human or animal consumption, is responsible for ensuring that their operations and products comply with all applicable laws and regulations.
The FDA's inspection of TruVision's facility was a for-cause inspection, triggered by suspected quality problems or complaints. The agency conducted the inspection to evaluate whether TruVision was complying with quality manufacturing practices and to follow up on any previous violations. The adequacy of TruVision's corrective actions was to be evaluated during the next inspection.
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TruVision's products were recalled due to mislabelling
TruVision Health LLC recalled several dietary supplement products due to the presence of unapproved dietary ingredients. The products contained hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine), which are not permitted to be sold as dietary supplements. Hordenine may be unsafe when ingested orally and may cause side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting, and insomnia. Octodrine, also known as DMHA, is not considered a dietary ingredient and is an unsafe food additive. Its use during exercise is potentially dangerous as no data on its metabolic pathway in humans exists.
Some consumers who used the recalled products experienced adverse reactions, including chest pain, chills, diarrhoea, dizziness, fatigue, headache, high blood pressure, high heart rate, jitters, nausea, nervousness, rash, stomach pain, sweating, and vomiting. These recalled products were sold online at Truvy.com to retail customers and distributed throughout the US, Canada, Australia, New Zealand, Germany, Ireland, and England.
The FDA posted the recall announcement as a public service, but it does not endorse the product or the company. TruVision Health offered consumers a full refund (excluding return shipping), an exchange, or the option to discard the product.
While the recall was due to the presence of unapproved and potentially unsafe ingredients, it is important to note that the issue was with mislabelling rather than the effectiveness of the products. The recall affected 12 dietary supplement products ordered through the TruVision website.
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Frequently asked questions
Truvision diet pills have been recalled due to the presence of potentially dangerous ingredients. The FDA has warned that these pills contain unapproved dietary ingredients, such as hordenine and octodrine/DMHA, which may cause serious side effects.
Some consumers have reported experiencing chest pain, chills, diarrhoea, dizziness, fatigue, headache, high blood pressure, high heart rate, nausea, nervousness, rash, stomach pain, sweating, vomiting, and insomnia.
Truvision, previously known as TruVision Health LLC, received a warning letter from the FDA in 2017 for serious violations of Good Manufacturing Practice. The FDA also found that Truvision was making unapproved claims about their products' efficacy and that their supplements were misbranded with incorrect serving size information.
Some users have reported positive experiences with Truvision diet pills, claiming significant weight loss and improved lab levels for thyroid and liver function. However, it is important to consult with a medical professional before taking any dietary supplements, especially if you have existing health conditions or are taking other medications.
