Nutrition and supplements in eye care – regulations do exist

When I discuss nutritional supplements with practitioners, one of the comments I often hear is that supplements are not “regulated,” meaning that just anyone can produce a product and sell it on the open market without scientific backing. Nothing could be further from the truth.

Consider that dietary supplement manufacturers must comply with a host of federal and state regulations involving ingredient safety, manufacturing, quality control, labeling, advertising, bioterrorism and postmarketing surveillance.

In 1994, the Dietary Supplement Health and Education Act (DSHEA) was enacted by Congress. This law defines dietary supplements as vitamins, minerals, botanicals, sports nutrition, weight management and specialty supplements that would be regulated not as drugs, but as foods. DSHEA also provided the US Food and Drug Administration with more, not less, authority over supplements than it had previously.

DSHEA defines the following mandates:

The FDA has the authority to remove adulterated or unsafe products from the market.
If a product contains an ingredient not listed on the label (or an inaccurate amount of an ingredient), the product is considered adulterated, and the FDA can impose sanctions on the company, ranging from imposing fines to removing the product from the marketplace to criminal prosecution of the manufacturer.
By law, dietary supplement manufacturers must adhere to Good Manufacturing Practices (GMPs) specific to dietary supplements that go beyond conventional food GMPs. These cover virtually every aspect of supplement manufacturing, labeling and quality control. If products are not made according to the GMPs the FDA can deem them adulterated or misbranded.
The FDA must be notified before supplement manufacturers introduce a new ingredient to the marketplace and they must have evidence of safety in support of the new ingredient.
Advertising and labeling for dietary supplements must be truthful and not misleading to consumers. FDA, Federal Trade Commission, and state agencies and attorneys general all have enforcement authority and have exercised that power with large civil fines and penalties.

If serious adverse events are reported, supplement manufacturers must notify the FDA within 15 days. This is a requirement comparable to prescription and some over-the-counter drugs, but not conventional foods.

It is true that dietary supplement products do not have to undergo the same premarket approval process as that required for drugs; however, premarket approval does not guarantee safety, as has been seen with pharmaceutical products being granted FDA approval, only to have them later removed from the market for safety reasons. In addition, dietary supplement manufacturers have a variety of other requirements to help assure product safety.

So, it is important to realize that recommending nutrition and dietary supplements can be a safe and effective tool in the prevention and treatment of chronic eye disease. Reputable companies have their boards of directors, as well as their ingredients openly listed on their websites. It is up to the eye care professional to learn which supplements to recommend, because consumers can easily get confused. Take some extra time to learn about nutrition and supplementation; it will advance your understanding of your patients’ needs and possible resolution to their eye care concerns.