Balance Of Nature Recall. The recent Balance of Nature Recall was issued on November 15 by the FDA. The court mandated that the company stop producing and selling its supplements. It is noted that the company needs to comply with the established rules and regulations governing food and drugs.
These supplements are usually available on platforms like Amazon and Walmart. However, these are temporarily unavailable until the companies rectify their practices to align with legal requirements.
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What Is Balance Of Nature?
In 1997, Dr. Douglas Howard founded Balance of Nature. He is a medical doctor and chiropractor. It aimed to address nutritional needs, especially in areas with limited access to food or where excessive fast food consumption leads to health issues like obesity.
It is a supplement comprising 100% freeze-dried whole fruits and vegetables. The primary product, Fruits & Veggies, is available in capsule form. It offers flexibility in consumption, like:
- Swallow with water
- Mix in a drink
- Sprinkle on food
- Chew like a treat
The recommended daily intake involves three capsules each of Fruits and Veggies, totalling six. Additionally, Balance of Nature offers Fiber and spice. It is a powder blended with water and taken twice daily. It consists of whole fiber sources and a combination of 12 herbs.
Is Balance Of Nature Out Of Business?
No, Balance of Nature is not out of business. After a recent recall, it says it’s back to selling and shipping its dietary supplements.
Balance of Nature claims they’re back to regular operations and shipping just in time for the holidays.
Evig’s CEO, Lex Howard, thanked the customers for their patience and ongoing support. He assured a commitment to providing top-notch products and excellent service in a statement.
According to a letter shared by Daryl Farnsworth of Balance of Nature, an FDA official informed the company that it seemed to be “in compliance” with supplement regulations. This means they can go back to making and distributing their supplements.
The FDA cautioned that they must stick to their agreement with the agency to keep selling Balance of Nature products. This agreement involved promising to handle customer complaints better and remove any marketing that breaks federal law.
Currently, there’s no comment from an FDA spokesperson on the matter.
Before, the FDA accused Balance of Nature of making many unsupported claims. They also had to settle a lawsuit in California over how they advertised their supplements.
The FDA also said that Balance of Nature’s manufacturer needed to do more to check if the ingredients in their products were what they said they were.
After the recall by the court in November, Evig, the company behind Balance of Nature, said they agreed to a Consent Decree without admitting to the accusations. They claimed to be already working on a plan to deal with the FDA’s worries. According to the agreement, they’re working with independent experts. So that they can regularly check if they’re following FDA rules.
Evig says they’re still committed to giving people high-quality supplements. Along with fruits, veggies, and Fiber, even with all these issues.
Why Did The FDA Say To Stop Making Them?
The FDA says the labels on these supplements claim they can be used to fix several diseases. Even though the FDA didn’t say, they could do that.
The FDA also says Premium Production LLC and Petersen made these products in a way that breaks some manufacturing rules. This means the products are now considered not good enough to be sold.
The FDA wants to ensure companies follow the rules so people can trust what they’re buying. Michael C. Rogers, from the FDA, said they warned these companies before. But they kept breaking the rules, so the FDA has to stop them now.
FDA Rules and Warnings for Supplement Companies
Companies making dietary supplements must follow certain rules called Current Good Manufacturing Practices (CGMP) set by the FDA. These rules make sure that accessories are made consistently. Also, there should be no harmful stuff and have clear labels. They also outline strict rules for saying what a supplement can do without making it sound like a drug.
In 2019, Evig LLC and Premium Production LLC got warning letters from the FDA. Evig was told that Balance of Nature’s labels and ads made it seem like their products were drugs. Also, they claimed that they could cure or prevent diseases like:
- Multiple Sclerosis
- High cholesterol
Premium Production didn’t follow the manufacturing rules, like testing the products for what’s in them and ensuring they’re pure. The FDA couldn’t give penalties despite these issues. They could only send warning letters or suggest the Department of Justice consider charges for dangerous or dishonest supplements.
Balance of Nature agreed to pay $1.1 million in July 2023, and some of it will be given back to people in California who bought their supplement. The California Food, Drug, and Medical Device Task Force accused Evig, LLC, saying their products could cure serious diseases.
Napa County District Attorney Allison Haley said Balance of Nature made risky claims about their products. These claims put people’s health at risk. She added that customers should expect products to do what they say.
Apart from false ads and unproven medical claims, California also said Balance of Nature wrongly charged customers for a subscription that didn’t clearly explain the terms. Also, it didn’t get clear permission from customers and didn’t let people cancel online if they signed up online.
Why Are Balance Of Nature & Other Nutritional Supplements So Popular?
Nutritional supplements are popular because they promise easy solutions to various health issues. They claim to provide the benefits of fruits and veggies without the effort of preparing or eating them. Marketed as a quick fix, these products have become a booming $52.9 billion industry. Also, it is expected to grow over 5% annually.
While health experts advise eating a variety of whole fruits and vegetables for a balanced diet, the rise of supplements suggests a gap in people’s actual consumption of these foods. However, relying on pills instead of real food may offer different benefits.
For instance, the balance of Nature’s supplements claims to provide the nutritional equivalent of fruits and vegetables. However, experts caution that these pills’ small amounts of dried powder may not offer the same benefits as whole foods.
Also, there’s limited evidence supporting their role in reducing cancer risk. The American Cancer Society recommends getting nutrients from food, suggesting balanced multivitamin/mineral supplements for general health.
While supplements might be necessary in specific situations, for example:
- Folic acid for pregnant individuals to reduce congenital disability risks
- A mix of nutrients for vision loss in macular degeneration
- Calcium and iron are not a one-size-fits-all solution for those lacking these nutrients from food.
- Vitamin D is advised for those with insufficient exposure to sunlight.
- Vitamin B-12 for those over 50 who may struggle to absorb it from food
Companies Must Follow Rules Before Selling Again
The companies must do a few things before they can start making and selling their products again. They need to hire experts to ensure they follow the rules, show documents to prove they’re doing things right and get the FDA’s approval.
Evig LLC has to get someone who knows about labels to ensure their products are no longer called new or misbranded drugs. They must do all these things before making or selling their products.
The Deputy Assistant Attorney General, Brian M. Boynton, said products that can treat or cure diseases need permission from the FDA. He also mentioned that dietary supplement companies must follow health and safety rules. The department will keep working with the FDA to stop the sale of products that don’t follow the rules.
Best Alternatives To Balance Of Nature
If you’re thinking about buying freeze-dried supplements, several alternatives exist. Even before having problems with the FDA, Balance of Nature faced tough competition. Below, you can check a few other options for Balance of Nature:
For their main product, Fruits & Veggies, Balance of Nature has some rivals:
- Simply Nature’s Promise Simply Fruits & Veggies: Similar to Balance of Nature, but cheaper at $59.95.
- Justified Laboratories Vital Fruits & Veggies: Even more affordable at $49.95.
- Terra Kai Organics Super Fruits & Veggies: Another option for $49.95.
- Juice Plus Fruit & Vegetable Blend: More vitamins and a longer return policy (180 days).
Alternatives to Balance of Nature’s Fiber & Spice:
- Garden of Life Raw Fiber Powder: Cheaper at $38.99, with added omega-3 and probiotics. Also, a longer money-back guarantee (60 days).
- My Source Nutrition Fiber G: Costs $39.99 and is similar in price but without the extra benefits.
- NorCal Organic Fiber: It is cheaper than Balance of Nature. It’s organic with transparency about safety testing.
Other options might be better and more budget-friendly than Balance of Nature, even before all the FDA issues.
In conclusion, the FDA’s recent recall of Balance of Nature supplements highlights serious concerns about their safety and compliance with regulations. The court-ordered stop in production and sales follows repeated violations. It has happened due to misleading claims and manufacturing lapses.
Customers should be cautious about using these products, considering the FDA’s findings and the need for the companies to rectify these issues before resuming operations. It emphasizes the importance of thorough research and awareness when choosing dietary supplements.
The recall serves as a reminder that ensuring product safety and adherence to regulations is crucial for companies in the health and wellness industry.