Juice Plus is not FDA approved, and it never will be, because it doesn’t need to be. Juice Plus is classified as a dietary supplement, and the FDA does not approve dietary supplements before they go to market. This is true of every supplement you can buy, not just Juice Plus. The distinction matters because it shapes what the product can legally claim and how much oversight it actually receives.
Why the FDA Doesn’t Approve Supplements
The FDA operates under two completely different systems for medicines and supplements. Prescription and over-the-counter drugs must go through a formal approval process, including clinical trials proving safety and effectiveness, before they can be sold. Dietary supplements skip that entire process. As long as a supplement doesn’t contain a new ingredient introduced after October 15, 1994, the company selling it doesn’t even have to submit safety evidence to the FDA before putting it on shelves.
Supplement manufacturers are responsible for ensuring their products are safe and that label claims are truthful. They must follow Good Manufacturing Practices covering identity, purity, strength, and composition. But this is self-policing. The FDA only steps in after the fact, pulling products from the market if they turn out to be unsafe or if the company makes misleading claims. It’s a reactive system, not a preventive one.
When a clinical trial on Juice Plus was registered on ClinicalTrials.gov (studying its effects on cardiovascular health in people with type 2 diabetes), the filing explicitly noted: “Studies a U.S. FDA-Regulated Drug Product: No” and “Studies a U.S. FDA-Regulated Device Product: No.” That’s standard language for supplement research.
The Disclaimer on Every Bottle
If you’ve looked at a Juice Plus label, you’ve likely noticed the standard FDA disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This isn’t optional. Federal law requires this exact wording on any supplement that makes a structure or function claim (like “supports immune health”). Companies cannot modify the text. Every supplement brand carries it, so seeing it on Juice Plus packaging is normal, not a red flag.
What Juice Plus Has Instead of FDA Approval
While Juice Plus lacks FDA approval (like all supplements), the company has pursued third-party certification through NSF International, an independent testing organization. Multiple Juice Plus products, including the Fruit Blend, Vegetable Blend, Berry Blend capsules and chewables, the Complete shake mixes, and the Essentials line, are certified under NSF’s Guideline 229 for Functional Foods. These products are manufactured at facilities in Garden Grove, Santa Cruz, and Vista, California.
NSF certification means the products have been tested to verify that what’s on the label matches what’s in the capsule, and that contaminant levels fall within acceptable limits. This is meaningful because supplement labels aren’t always accurate. Third-party testing closes some of the gap that the lack of FDA pre-approval creates, though it’s still not equivalent to the scrutiny a pharmaceutical drug receives.
Regulatory Actions Against the Company
Juice Plus has drawn regulatory attention at least once. In June 2020, the Federal Trade Commission sent a warning letter to The Juice Plus+ Company related to claims made during the COVID-19 pandemic. The FTC monitors advertising claims for all consumer products, and supplement companies frequently receive these letters when their marketing language crosses the line into implying disease prevention or treatment.
This is worth knowing because it illustrates the broader issue with supplements: without FDA pre-approval, the burden falls on regulators to catch problematic claims after they’ve already reached consumers.
What the Research Actually Shows
Juice Plus contains dried concentrates of fruits and vegetables, and a handful of peer-reviewed studies have tested its effects. One randomized, double-blind trial published in the Journal of the American College of Cardiology found that four weeks of taking Juice Plus capsules reduced the negative impact of a high-fat meal on blood vessel function. Participants who took the supplement saw their blood vessels recover significantly better after eating a 900-calorie, 50-gram-fat meal compared to the placebo group. The supplement also raised blood levels of nitrate and nitrite, compounds that help blood vessels relax.
That said, the capsules themselves contain relatively modest amounts of vitamins. Four capsules of the Fruit Blend provide about 20 mg of vitamin C (for comparison, a single orange has roughly 70 mg) and some beta-carotene. The product isn’t meant to replace fruits and vegetables, and no study has shown it’s equivalent to eating whole produce.
Safety Concerns to Be Aware Of
Juice Plus is generally tolerated by most people, but it’s not without risks. Clinical trials have documented gastrointestinal discomfort and hive-like rashes in some participants. Memorial Sloan Kettering Cancer Center flags a more serious concern: because Juice Plus has antioxidant properties, it could theoretically interfere with chemotherapy and radiation treatments that work by generating free radicals to kill cancer cells. The center advises against taking it during those treatments.
In one documented case, a 51-year-old woman with endometrial cancer developed elevated liver enzymes while taking Juice Plus, which interfered with her cancer treatment. Her liver function returned to normal within four weeks of stopping the supplement. While a single case report doesn’t prove the supplement caused the problem, it’s a reminder that “not FDA approved” also means “not rigorously screened for drug interactions.”
What This Means for You
The absence of FDA approval doesn’t make Juice Plus dangerous or fraudulent. It places the product in the same regulatory category as every other dietary supplement on the market: legal to sell without pre-approval, required to follow manufacturing standards, and subject to enforcement action only if problems emerge. The NSF certification provides an extra layer of verification that many supplements lack. But “not FDA approved” also means no government agency has independently confirmed that the product does what its marketing suggests. You’re relying on the company’s own evidence, a handful of published studies, and third-party lab testing rather than the rigorous approval process that prescription medications go through.