Macular Degeneration and the FDA: What They Do and What They Don't Do
If you are in the U.S., you most likely recognize that the letters 'FDA' mean the Food and Drug Administration. Do you know, however, what they do and what they don't do? Do you know why it is important for you to know if you have AMD?
The FDA's Mission
Their mission as is as stated on their website: "The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation."1
There is more, but even with just that, it's easy to think that the FDA is the authority on everything related to food and drugs. We see 'FDA Approved' and may judge that to be a guarantee that they "have our back." However, I'll bet that you haven't thought about how the FDA relates to your diagnosis of AMD.
AREDS and AREDS2 supplements
Has your eye specialist recommended that you take something called AREDS? I've had people tell me that they were told to take everything from 'Arats' to 'reds.' 😀 From my experience, this is one of the most misunderstood topics of all those of AMD. I've written about it in 'What About Those Eye Vitamins'. We also discuss the topic regularly on the MacularDegeneration.net Facebook page.
The FDA does not regulate supplements
What I'm here to help you understand regarding the FDA and AREDS2-based supplements is that the FDA does NOT regulate supplements like they do medications.
The extent of the FDA's involvement
Supplements are categorized basically as food (dietary supplements) and this is the extent of the FDA's involvement with them:2
- New supplements are NOT reviewed and approved by FDA for their safety and effectiveness before they are marketed. They need to be labeled as a dietary supplement or the equivalent, but that is all.
- If a product has a new dietary ingredient - vitamins, minerals, amino acids, and herbs or botanicals (things such as vaccines or drugs that are derived from biological sources) and others taken by mouth - they have to notify the FDA, but that is all.
- Only if there are public safety concerns does the FDA look at a product for safety issues and monitor adverse events. Manufacturers are required to report 'serious' adverse events, but that is all. Consumers are encouraged to report adverse events, but many do not.
- They do not evaluate claims such as "It will reverse your macular degeneration!" or even 'It will slow the progression of AMD." A company that does make a claim must notify the FDA, but that is all.
- Even though it is not legal to make claims that a dietary supplement is a treatment or cure for a specific disease or to alleviate symptoms of a disease, the FDA says, "FDA reviews substantiation for claims as resources permit."
Other dietary supplements
In addition to this lack of safety and effectiveness assurance for AREDS2-based supplements, it also applies to some of the frequently-discussed dietary supplements that are not backed by any or much scientific research such as those containing saffron, bilberry, turmeric, CBD oil, and others.
Without clinical trials and without FDA oversight, how do we know if a supplement is safe for us? Anything we put in our mouths - which is what a dietary supplement is - has the potential to help or harm.
What does this mean for you as a consumer of these supplements?
We need to do our homework regarding any supplement we take just as we need to do with medications. Some dietary supplements are fine for some people but not others. We will, however, not get much guidance from the FDA on that.
You can get fact sheets with information about dietary supplements from the NIH (National Institute of Health) Office of Dietary Supplements.3 These fact sheets contain information about reported adverse events, recommendations for any RDAs (Required Daily Allowance), what the supplement does or doesn't do, whether it can be harmful, and references to more information if it is available.
What else does the FDA do and not do?
I may have missed some, but here are the main ones that we as consumers need to know about:6
- DOES NOT: FDA does not approve health care facilities, laboratories, or manufacturers. FDA does have authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations. The 'good manufacturing practice regulations' topic is a complex one. You can find more about it on the FDA's website.
- DOES: New drugs and certain biologics must be proven safe and effective according to the FDA’s regulations before they can be marketed. This includes FDA Approved treatments for macular degeneration including anti-VEGF injection medications for wet AMD.
- DOES: Some examples of biologics that require approval are therapeutic proteins, vaccines, cellular therapies, and blood and blood products. This relates to stem cells inappropriately used for the eyes. More below.
Treatments for AMD
Until there is a cure or more treatments for AMD, there will be people looking for them everywhere. The Internet provides a lot of help finding them. Unfortunately, there are people and companies who are making a lot of money preying on this need to DO SOMETHING - anything - to stop vision loss!Stem cell treatmentThere are several so-called treatments for AMD, but the one I want to talk about now is the use of stem cells that are injected into a person's eye for the purpose of impacting AMD in some way.Stem cells are considered biologics, and the FDA DOES regulate the use of them.FDA-approved stem cell therapiesStem cell treatments are currently being researched with promising results, but there are no safe and effective FDA-approved stem cell treatments available outside of clinical trials.The FDA has warned of the dangers of these unproven and unapproved stem cell therapies. People have been blinded by them. I highly recommend that you read the entire statement and the watch video in it. They say:5"Stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what’s really being offered before you consider any treatment."Other so-called treatments for AMDThere was a recent post in my Facebook group about a microcurrent device which is one where electrical current is applied to the body. In this case, it was applied to the area around the eyes. The post claimed the device was FDA-approved. Two fallacies:It was NOT FDA-approved, but it was FDA-registered which is quite different; It was FDA-registered for specific use: muscle stimulation as is used by some physical therapists, for example, certainly not for the eyes or AMD. FDA Approved is quite different than FDA Registered.6There are other so-called treatments for AMD. Alas, I've run out of space, again! (Is there actually anyone here reading this? 😀)The buyer alone is responsibleThere are criticisms of the FDA's system of regulating drugs that can get into the topic of 'Big Pharma.' That doesn't even apply to us because for the AREDS2-based products, other supplements, and devices, the FDA does not help us as consumers.I leave you with a definition of 'caveat emptor': "The principle that the buyer alone is responsible for checking the quality and suitability of goods before a purchase is made."
Do you find it easy to advocate for yourself?