TL;DR
If you’ve been looking into supplements for age-related macular degeneration (AMD), you’ll have come across the AREDS2 formula. And one of the first questions most people ask is whether it’s been approved by the FDA. The short answer is no, but that doesn’t mean what you might think. The FDA doesn’t approve any dietary supplement before it goes on sale. Here’s what that actually means for you and your eye health.
How the FDA regulates dietary supplements
The U.S. Food and Drug Administration (FDA) treats dietary supplements very differently from prescription drugs. Pharmaceutical medicines have to go through a formal approval process before they can be sold. That involves years of clinical trials, safety reviews and an official sign-off from the FDA.
Dietary supplements don’t follow that route. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements are classified as a special category of food. Manufacturers are responsible for making sure their products are safe and that any claims on the label are backed by evidence, but they don’t need FDA approval before putting a product on the shelf.
The FDA’s job is to monitor the market after products are available, step in if something is unsafe and take action against misleading claims. So when you see “this statement has not been evaluated by the FDA” on a supplement label, that’s standard for every dietary supplement, not just AREDS2.
Are AREDS2 Supplements Approved in the UK?
If you’re buying supplements in the UK, the regulatory picture is different again. The Food Standards Agency (FSA) oversees food supplements, and they’re regulated under the Food Supplements Regulations 2003.
Like the FDA system, UK supplements don’t require pre-market approval for safety or efficacy. However, only vitamins and minerals from an approved list can be used, and any health claims must be authorised and backed by scientific evidence.
The Medicines and Healthcare products Regulatory Agency (MHRA) draws the line between food supplements and medicines. If a product claims to treat, cure or prevent a disease, it’s classified as a medicine and needs a licence. That’s why you won’t see AREDS2 supplements making those kinds of claims on the label, even though the clinical evidence behind the formula is strong.
What the AREDS2 formula actually is
AREDS2 stands for Age-Related Eye Disease Study 2. It’s a formula that came out of a major clinical trial funded by the National Eye Institute (NEI) in the United States. The original AREDS study, published in 2001, found that a specific combination of vitamins and minerals could reduce the risk of intermediate AMD progressing to the advanced stage by around 25%.
The AREDS2 follow-up study, launched in 2006 and published in 2013, refined that formula. Researchers replaced beta-carotene with lutein and zeaxanthin after studies linked beta-carotene to an increased risk of lung cancer in smokers. The updated AREDS2 formula contains:
- Vitamin C (500 mg)
- Vitamin E (400 IU)
- Lutein (10 mg)
- Zeaxanthin (2 mg)
- Zinc (80 mg)
- Copper (2 mg)
The swap to lutein and zeaxanthin wasn’t just about safety. A 10-year follow-up study confirmed that the AREDS2 formula was more effective than the original, showing an 18% additional reduction in the risk of progressing to advanced AMD compared to the version with beta-carotene.
Related read: What To Look For In Eye Supplements: Ingredients List
Why the lack of FDA approval doesn’t matter as much as you’d think
It’s easy to hear “not FDA approved” and assume a product hasn’t been properly tested. With AREDS2, the opposite is true. The formula is one of the most thoroughly researched supplement combinations in ophthalmology. It was developed through a large-scale, randomised clinical trial involving over 4,000 participants across 82 clinical sites, and it’s backed by more than a decade of follow-up data.
The NEI itself recommends the AREDS2 formula for people with intermediate AMD in both eyes, or intermediate AMD in one eye and advanced AMD in the other. That recommendation carries real weight. The fact that the formula doesn’t carry an “FDA approved” stamp is purely a regulatory classification issue, not a reflection of the evidence behind it.
Who should take AREDS2 supplements?
AREDS2 supplements aren’t for everyone. The studies specifically looked at people with intermediate to advanced AMD. If you have early AMD or no signs of the condition at all, the research doesn’t show a benefit from taking these supplements.
Our expert’s opinion
Your optometrist or ophthalmologist will be able to tell you which stage of AMD you’re at and whether an AREDS2 supplement is appropriate. If you’re a current or former smoker, it’s particularly important to use the AREDS2 version of the formula, which replaces beta-carotene with lutein and zeaxanthin, to avoid the associated lung cancer risk.
It’s also worth checking the label carefully. Not all supplements marketed as “eye vitamins” follow the exact AREDS2 formula. Some contain different doses or additional ingredients that weren’t part of the original study. Look for products that match the specific nutrient profile tested in the trial. Our own Eyesight+ follows the AREDS2 formula exactly.
What to look for when you buy
Quality can vary between brands, so there are a few things to keep in mind. Check that the supplement contains the correct doses of each ingredient as tested in the AREDS2 study. Some products include omega-3 fatty acids, but the AREDS2 trial found these didn’t provide additional protection against AMD progression.
Third-party testing for quality and purity is another good sign. And if you’re taking other medications, speak to your GP or pharmacist first. High-dose zinc, for example, can interact with certain antibiotics and diuretics.
The evidence matters more than the stamp
No dietary supplement is FDA approved, and AREDS2 supplements are no exception. But the AREDS2 formula is backed by one of the most rigorous clinical trials ever conducted for an eye health supplement. The NEI recommends it, and over two decades of research support its use for slowing the progression of AMD in the right patients.
The question isn’t really whether AREDS2 is FDA approved. It’s whether the evidence supports it. And on that front, the answer is clear.
