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How safe is Dwelle?

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  • How safe is Dwelle?

    Now that Dwelle is back in stock - I'm thinking about ordering it. First, I'm wondering how safe this product is. Have there been any independent studies done on it? Is it FDA approved? What quality controls are in place for testing it? Where is it manufactured?

    Given that it is to be used on the eyes, the oh so precious eyes, it would make me feel better to know more about this product other than that it is very beloved by it's many users. I realize that it is highly effective, but really want to be assured that it is also safe and has been clinically test by an independent lab.

    Also - any independently conducted longitudinal studies done on this product to test safety over time?

    Of course, I want to believe in the product 100%, but I've learned (through trial and error) to be a more cautious consumer - especially when it comes to healing the body.

    Thanks everyone for any information you can provide. Outside of this wonderful website, I've seen very little information on Dwelle, Dakrina, or Nutratear - which makes me nervous. I understand the contracting/production issues, but just don't see much out there in the way of research or discussion.

  • #2
    Caution is good!!

    Dwelle is manufactured in the US at an FDA GMP approved facility.

    For background on "FDA-approved" and safety issues, the FDA does not approve products in this category like they do prescription drugs. Instead, the FDA has a sort of checklist for how a drop can be deemed automatically approved (so to speak). It's called the FDA monograph for OTC ophthalmic demulcents. Basically, there is a list of active ingredients and maximum concentrations thereof that the product can have. If you fall within that, you are considered compliant and do not have to seek the kind of approval that applies to prescription drugs. Such monographs exist for many kinds of products sold over the counter. Dwelle, as well as Dr. Holly's other drops, are compliant with the FDA monograph. Dwelle was formulated specifically to achieve very high oncotic pressure while still staying within the FDA's restrictions for OTC lubricant eye drops.
    Rebecca Petris
    The Dry Eye Foundation