Human Nature has noted with sadness the FDA Advisory 2017-328 dated Jan 8, 2018 advising the public not to purchase our DEET-free Bug Shield Oil. Firstly, we accept that the product is currently unregistered and would like to acknowledge that Human Nature will fully comply with FDA’s Advisory. We have already taken steps to request our partners to withhold the product from sale until FDA issues an updated product registration. Secondly, we would like to advise that we have the utmost respect for the people working in FDA and the FDA itself as an institution. In all our dealings with FDA, we have always found FDA to be completely honest, helpful and to genuinely act with 100% concern for the Filipino public. Since we have the utmost admiration for FDA, we did not respond to the Advisory publicly immediately, but have spent this week attempting to resolve the issues surrounding the registration of our product with FDA, specifically issues around animal testing.
We would like to assure the public that our Bug Shield has been proven effective and safe by third party bio-efficacy testing and safety assessment. All our ingredients are 100% natural and commonly recognized as safe. The complete list of our Bug Shield’s ingredients is:
Helianthus annuus (sunflower) seed oil, Glycine soja (soy bean) oil, Cymbopogon winterianus (citronella) essential oil, Citrus sinensis (orange) essential oil, Eucalyptus globulus (eucalyptus) essential oil, glyceryl caprylate (coconut, palm and glycerin derived). There are no ingredients which will pose any danger to the public at all.
We would also like to state that 100% of the profits of this product go to Gawad Kalinga and other accredited community development organizations. Human Nature does not earn anything from this product. The citronella oil used in it is produced by farming communities in Labo, Camarines Norte; Malaybalay, Bukidnon and Impasug-ong, Bukidnon, which we buy at almost double the market price, enabling these communities to rise out of poverty. Producing this citronella oil constitutes almost the entire livelihood of these communities and taking Bug Shield off sale will cause severe hardship to them unless we are able to successfully register it with FDA very soon. This is the reason we continued to offer Bug Shield for sale while waiting for the release of the product registration. We were very much hoping to resolve the situation quickly and have been willing to pay all penalties and suffer all consequences in order to protect the livelihood of our farming communities which depend on Bug Shield.
The reason we have been unable to successfully register Bug Shield this time is simply that FDA regulations require a toxicity test for all bug repellants, which will entail animal testing. Toxicity studies require several tests that include putting the product in the eyes of the animal until it goes blind, forcing animals to inhale products until the point of suffocation and forcing animals to ingest the product in bigger and bigger quantities until it dies. Human Nature is 100% animal cruelty free and was the first company in the Philippines to be accredited cruelty-free by PETA, the world’s largest animal welfare organization. Hence, we have been lobbying to provide alternative studies to prove that Bug Shield is safe and non-toxic, especially considering the very safe and well-known nature of the ingredients we use. We view the requirement for animal testing to constitute unnecessary cruelty and have been hoping to convince FDA of that for several months.
In previous years, FDA accepted our alternative safety data and we successfully registered various forms of our Bug Shield. But when we attempted to register this last June 2017 and paid all fees, we were advised that the documents would not be accepted without the toxicity data, which can only be obtained through the forms of animal testing outlined above.
We have tried unsuccessfully since then to convince FDA to accept our data. After further discussion with FDA this week, we have now been allowed to submit additional documents to prove safety in place of animal testing but we have been told to stop selling while they review our case, which can take up to 175 days. As stated earlier, we will comply 100% with this directive, but we are very concerned that this will cause hardship for our farming communities and so we very much hope for a speedier review of our data. We are confident that the documents we have submitted are enough evidence of our product’s safety and efficacy and we trust in the expertise of the FDA to judge our product as such.
We are issuing this statement so that our customers and partners will understand clearly the issue leading to the late registration of our Bug Shield and to assure them all that Human Nature always takes the utmost care in ensuring absolute safety of all our products. We fully support FDA’s mandate to protect consumers and we look forward to an outcome which allows people to continue to choose safe, natural bug repellants which are free from animal cruelty, in line with the values of many Filipinos today.