While all drugs sold to American consumers face a rigorous approval process, that's not the case when it comes to supplements. The Food and Drug Administration (FDA) does not approve supplements, and while there are some limits to the claims that can be made by companies in this space, there's a fair amount of latitude.
"The manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a 'disclaimer' that FDA has not evaluated the claim," according to the FDA website .
Supplement makers can make certain structure/function claims without FDA preapproval, as long as they have substantiation that the claims are truthful and not misleading, and that they meet the agency's other requirements.
"The disclaimer must also state that the dietary supplement product is not intended to 'diagnose, treat, cure or prevent any disease,' because only a drug can legally make such a claim," the federal agency shared.
It's a legal grey area that allows supplements to advertise that they can help with fitness, hair growth, sleep, and your ability to focus.
Synergy CHC Corp., the maker of Focus Factor, which is described on its Amazon sales page as a "Brain Supplement for Memory, Concentration and Focus," has filed for Chapter 11 bankruptcy .
Synergy makes some bold claims about what Focus Factor can do for consumers.
Focus Factor Extra Strength brain supplements contain a powerful combination of vitamins, minerals, and neuro-nutrients that not only power your brain but can also replace your daily multivitamin," it shared.
The company, on Amazon, also said that the supplement promotes concentration and memory.
"Like other parts of your body, your brain needs proper nutrition to perform its best. This advanced formula improves and enhances memory, concentration, and your ability to focus," it added.
Synergy CHC backs that up with the following claim that doesn't directly speak to efficacy.
"Focus Factor is the #1 Pharmacist Recommended Brand based on the results of the U.S. Pharmacy Times Survey of Pharmacists' OTC Recommendations for 'Memory Support' dietary supplement, 2025-2026," the company shared.
Synergy CHC Corp. develops and markets consumer health and wellness products, led by its flagship brands Focus Factor and Flat Tummy.
"Focus Factor, a clinically studied brain health supplement and functional beverage line with a 25-year legacy, enjoys established distribution in the U.S., Canada, and Mexico through major retailers including Walmart, Amazon, BJ's, and Walgreens, among others. Flat Tummy complements Synergy's portfolio as a lifestyle brand focused on women's wellness and weight management," the company shared in a press release .
Synergy CHC warned of potential significant financial problems after it received notice from Costco that the warehouse club would be dropping the company's products.
Reporting synthesized and verified under Nexvoro.tech editorial guidelines. Full primary records referenced via Yahoo Finance.
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