The FDA Only Knocks Once: The Story of Montana Emu Ranch Company
- Tammy
- Jul 1, 2019
- 8 min read
Feds and Farms
What is the Food and Drug Administration ( FDA )? It's a government agency which oversees the safety of roughly 80 percent of the country’s food supply. It also regulates everything from drugs to cosmetics.
According to the FDA, their origins as a "federal consumer protection agency" began with the passage of the 1906 Pure Food and Drugs Act. "This law was the culmination of about 100 bills over a quarter-century aimed to reign in long-standing, serious abuses in the consumer product marketplace. Federal public health protection was vigorously advocated by Harvey Washington Wiley, who at the time was chief chemist of the Bureau of Chemistry of the U.S. Department of Agriculture, FDA’s predecessor. The 1906 Act was passed thanks to his efforts and in response to the public outrage at the shockingly unhygienic conditions in the Chicago stockyards that were described in Upton Sinclair’s book 'The Jungle.' Eventually, the position of chief chemist of the Bureau of Chemistry evolved into that of the commissioner of food and drugs." ~
As you can imagine, it's a much needed federal office whose goal is to protect the consumer. Who doesn't want safe food and drugs? Conservatives, moderates, and liberals would agree, though regulations and the distribution of funding can be controversial. While the FDA's history of operation was once reactionary, a health advisory panel in 2010 urged them to be more proactive in preventing consumer safety problems. When the Food Safety Modernization Act (FSMA) was originally proposed that same year, and the FDA was given authority over farms, many were troubled. "Small-farm and organic food advocates warned that the legislation would destroy their industry under a mountain of paperwork and other requirements."
What has this meant for small farms such as the Montana Emu Ranch Company ( MERC )? It means costly and burdensome paperwork; lots of it. "Ain't No Mountain High Enough" might prove too high for some to survive when it comes to government regulations. Small farms aren't exclusive, but businesses, large corporations, organizations ( including nonprofit ), schools, governments, consumers and citizens alike. Protection is a double entendre that comes with a cost; a very high one.
Regulation can be an important ( and needed ) government function to ensure production safety. However, as important as the FDA is for consumer protection, the American Dream must be attainable for each American citizen. It also must be able to continue as a legacy of American standard instilled by previous generations. Especially in the case of the small family farm.
The American Dream
What is Montana Emu Ranch Company ( MERC )? It's a small emu farm born in 1992 from a couple's American dream to help people naturally. Their motto became, Nutrition for the Skin, and they produce
natural products made in the USA from Kalispell, MT.
MERC owners Don and Penni Collins both had 9 to finished-for-the-day jobs ( meaning much longer than the typical 8 hours ) before starting the company on their kitchen counter each evening following work and livestock chores. They expanded to fairs and farmers markets because, "In the 1990’s NO ONE knew what emu oil was!" said Penni Collins. "We grew as we could, and hired people when we were able. We now have 12 staff members covering office, shipping, lab, and ranch work. We are a small company and everyone feels like family."
Don and Penni were both born in Kalispell, but never met despite attending the same high school. They wouldn't meet until life brought them back to Montana almost a decade later, where Kalispell was an ever-changing landscape.
How?
After graduation, Penni headed for California and Alaska to work/manage motorcycle shops, while Don headed to Arizona for construction work. Penni yearned to leave the hustle of the city and return to Kalispell to pursue her two passions: horses and motorcycles. Don grew tired of the south-western heat and moved back about the same time. Both landed jobs at Kalispell Cycle, a local motorcycle shop, as a parts manager andsalesman.
It would be the first time the two would meet since gtowing up in the same town. As both were seeing other people, they became good friends. Penni attributes this and their life experiences as "what prepared us for our business to come." While Don mastered sales, Penni learned inventory control, price comparison, and public relations. "Don later moved on to become a Beer and Wine salesman, where he learned about marketing, and price levels from cost through distributor, wholesale and finally retail," said Collins.
It wasn't until an evening among friends at the famous Moose's Saloon with Penni's dog, Cam (an 85 pound Viszla mix they hid under the table ), followed by an evening of dancing, that fate finally brought them together as a couple.
"Don drove me home and never left! That was 37 years ago. We celebrated our 30th wedding anniversary April of this year," Collins added.
Yet, it would take another 14 years and tragedy before Montana Emu Ranch was born.
When Kalispell Cycle went out of business, Penni worked at Leland’s Honda/Suzuki, while continuing to participate in various horse competitons/shows. Don pursued beer/wine sales, and a newfound passion for Bass Fishing ignited during a fishing trip with Penni. He qualified for Montana's national Bass team competition multiple times, and continues to contribute to the conservation of the sport. The Collins were happy and content.
EMUgency
It was an endurance horse race in Washington state that first introduced the Collins to emus. Penni almost dropped out because the girl who was to accompany her withdrew at the last moment. "Again Fate had a hand in our lives. Don went with me instead, and on our way back we stopped at Don's sister's in Spokane. She had purchased some Emus, and they looked pretty interesting. We studied up on them and decided to give it a try," said Penni. It was around 1992 that the Collins purchased their first emu.
The following year, in 1993 tragedy struck; Penni was in a horse accident that broke 5 ribs and her left scapula off. Unknown to doctors were additional internal injuries. "I was in emergency and the hospital overnight. They thought they fixed me but no one knew my pancreas was damaged also." said Collins. It took a week to diagnose her condition. "In the meantime I almost died.", she added. In the hospital for 20 days on intravenous antibiotics and food, "They said I would be diabetic and all sorts of bad things."
"THAT is what put Don and I on the road to NATURAL," said Collins. "We got me healed, and started wanting to help people live their lives without chemicals."
The Collins ( circled below ) worked diligently for the next 12 years, and saved up enough for a trip to Australia in 2015. They had dreamed of traveling to see where their emus originated, and learn more about them. Their America Dream had come true.
"Don and I both gave up our passions to get the business going. Every single cent and every single second of time we had went into the business," said Collins. Then one autumn day in September, 2016, there was a knock on the door:
"FDA calling."
The Enchanted Forest
In fairy tales there always seems to emerge an enchanted forest signifying transformation. Folklore describes them as mysterious metaphors unfamiliar to their characters; a place of threatening danger, one of refuge -- or, in many cases, both. They present testing grounds for growth, and one always has a choice of which direction to go. That decision will determine if you discover the light at the end of the tunnel to your dreams, or wander aimlessly through the maze trying to find your way back to where you started from.
So much of the American Dream relies on compliance with government agencies. You can start a small business if you meet requirements. You can sell your personal items in your own yard as long as you report the income. You can claim a fact only if it doesn't mislead consumers, aka, despite physical proof that it heals a condition from personal testimonies of individuals and you must have clinical studies to support your claim. The regulations are endless. . .
And with testimonies such as these regarding MERC ( from the FDA's warning letter, dated April 20th, 2017 ), it's no wonder the Collins were investigated: “At my last exam [my doctor] told me he saw signs of the beginnings of macular degeneration. He did the first part of the [current] exam ... Finally, he looked at me and said, ‘…Your eyes are BETTER than they were a year ago!’ Told him about the Vital Stats, which is the only major change…”
"3 month old baby…developed eczema…rashes on her arms, stomach, legs and bottom… recommended this product for the itching and healing…sprayed her all over and she IMMEDIATELY stopped scratching…less than 24 hours with using EMUgency…my baby’s skin is healing…"
"Photographs identified as March 2010 and June 2011 accompanied by: “I have systemic eczema…The eczema covered my entire body…It now has healed…I apply…VitalStats…internally…”
The testimonies regarding MERC have accumulated over 25 years, and are a mountain of endless verification from consumers as to the effective use of said products. Yet, despite the free speech of their customers, the Collins discovered just how limited they were in regards to sharing that information with consumers. When the FDA knocks, you scramble. Literally scramble, because you have mere weeks to respond; two, to be exact. Or, 15 business days, according to the FDA's warning letter. You must provide written verification of compliance, or a game plan of corrections within that small allotment of time. How are the Collins and their loyal consumers responding?
"We are co-operating with the FDA requirements while still staying natural. We see our company hopefully back on its path within another year. We still offer wonderful quality products that work. Our customers and stores have helped us get through these challenges with great understanding," says Collins.
Out of the Woods
While the Collins haven't quite made it out of the woods yet, they do see light at the end of the tunnel, and are very grateful to the FDA for working with them to become compliant without closing their doors. Which, the FDA is more than willing to do, as long as you are making a verifiable effort to comply. In addition to gratitude for not having lost their dream even temporarily, the Collins are also more than willing to advise other small companies on how to avoid that particular area of enchanted forest.
"Realize that it is not IF the FDA will walk through your doorway, it is WHEN the FDA will walk through your doorway. We could have spared ourselves a lot of grief and expense if we would have visited the FDA website and learned more about labeling and claims. Even what size you legally have to use on your labels. By size I mean do you use ounces or ML, also the WORDS have to be a certain size, font and format," said Collins.
"Everything you say must have a double blind human or animal study behind it. Natural ingredients don’t usually have expensive studies because they cannot be patented. Make sure whoever you work with for your brochures, labels, website etc is familiar with FDA requirements. Make sure YOU are familiar with FDA requirements. EVEN THOUGH they change all the time." explains Collins.
You have to keep yourself updated. What happened to us would have put us out of business even 8 years ago. It is hard financially to recover from something like this. So do it right the first time; educate yourself, work on it NOW before you see that badge of FDA identification at your doorstep," .
"Our products work; people are coming back because they do work, even if the name can’t really say it," Collins added.
While the postman always knocks twice, the FDA only knocks once; and your ducks better be all in a row when they do. Or, in this case, your Emus!
"The FDA agent had a good analogy for us, 'It is like a speeding ticket—not everyone gets caught—but they will eventually.' " Collins concluded.
The long arm of the law is notorious for catching up to even to those who think they're playing by the rules.
Facing a potential inspection, or want more information on how to handle an FDA inspection? Click here and remember, it's not the end of your dreams; there's always a light at the end of the enchanted forest!
Want to learn more about Montana Emu Ranch Company? Call toll-free Customer Service at 1-888-444-4EMU, or visit their website below:
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