law office

Michele Simon and Lauren Handel of Foscolo & Handel PLLC will cover the top four legal issues for startup food businesses.

Watch the FREE 23 minute video here, post your questions and comments
https://circleup.com/community/article/presentation–the-top-4-legal-issues-for-food-startups/VMfLDCsAAKCj3k8k/

  1. Unlawful or risky marketing claims
  2. Marketing opportunities, such as key product certifications
  3. Managing product liability risks
  4. Unique regulatory compliance and liability concerns for innovative foods

This presentation will guide investors and companies through the legal nuances of operating, and investing in, upstart food businesses. Food and beverage start-ups are all the rage. Some are hoping to be the next high-tech protein supplement while others are angling for the hot gluten-free market. But before betting the farm, you need to understand the unique legal risks, compliance issues, and marketing opportunities impacting the value of a food business. An investor in a food business needs to consider more than the company’s financials and sales. You need to ensure, for example, that any product claims being made with the “pitch” for funding can be legally made when it comes to writing marketing copy.

IMG_9713The legalities of marijuana are evolving and unraveling before our very eyes and it’s an exciting to watch the industry growing from an underground secret to full blown conventions like the HempCon I attended last weekend in San Jose.

I attended the show because several of my friends (with prescriptions) wanted to buy their medicine but also because I was curious about what types of medibles are out there and what types of food manufacturing/regulation laws are not being followed.

Turns out- very few laws are being followed and it’s just a matter of time before a foodborne illness wipes a whole generation of 1960’s hippies and their Gen X pot smoking children as well.

The issue is quite simple and potentially easy to solve. In California and in many other states Marijuana is still not legal at the federal level. Because MIF’s are not completely legal, food production operations are not monitored by the FDA, USDA, or even the local state health department. It’s pretty much a free for all when it comes to making and selling MIF’s in dispensaries and hemp festivals across the U.S. As a result – Dispensaries are making and selling potentially hazardous food products without even knowing it!

Here are a few food safety violations I witnessed at the trade show:

  • Brownies without any ingredient statement, allergen listing or even a product description. Just a brown square wrapped in saran wrap.
  • Rice Crispy treats in unmarked clear packages without any mention of what they are made from.
  • THC dosed ice-cream made in a facility of unknown origin that was probably not inspected by the USDA, FDA or any dairy organizations.
  • Juice bottles in sealed anaerobic containers being kept and sold unrefrigerated.
  • Siracha hot sauce in a sealed airtight container. How do we know pH levels are low enough to prevent bacteria outgrowth? How do we know a proper thermal process has taken place?
  • THC level recommendations are non-existent. I did get the vague idea that 12 mg is enough for a serving but how much of that bar or cake has 12 mgs in it?

What are the risks that can occur here? Patients with food allergies are at risk if they don’t know what is inside the brownie they are eating. Dairy products need to be regulated to ensure that it is kept cold. Listeria is an organism that can show up in dairy products. Any container that is sealed up supports anaerobic spore forming toxing producing bacteria like C.Botulinum and S. Aureus.

With food violations all over the place- I would not advise anyone to eat a medible unless they know where it was made, who made it and you have perhaps even personally inspected their facility. I am amazed at how critical consumers are about the current safely manufactured food market and protest against GMO’s, artificial flavors and sugar but yet there does not seem to be much concern at all about unlabeled pot brownies made in a dirty basement somewhere in the suburbs. All products should have at the minimum ingredient statements, allergen statements and clear packaging describing the contents and medicinal levels. Ideally marijuana food makers would only want to make safe shelf stable food that does not require refrigeration but medible consumers are tired of brownies and other same old varieties and are demanding new ideas on how to ingest.

If you plan to buy MIF’s—proceed with caution. Stick with shelf stable cakes and cookies, don’t buy beef jerky, ice cream or anything that requires refrigeration unless you know and trust the maker personally. For fellow industry professionals out there I am preaching to the choir however there is a large market of consumers that have no idea that these products are in violation of GMP ‘s (Good Manufacturing Practices) and could lead foodborne illness or over dosing on the medicinal THC component.

 

 

 

 

 

 

The Fancy Food Show was in town this week! I love wandering around the show, checking out the trends and secretly searching for false claims, labeling violations or stuff that is just misleading! That’s what food scientists do, and then we pick up the phone, call the FDA and make sure violating entrepreneurs are BUSTED!!

But the reality is, there are just way to many products out there for the FDA to inspect for compliance and unless your product is under USDA jurisdiction, you don’t even have to have it inspected or approved before putting it on the shelf. This is all the more reason to do your diligence and make sure you don’t accidentally lie, mislead or omit any important information.

Here are a few common mistakes that start up food entrepreneurs make that could result in a product recall or even worse—causing someone to get sick or die!

Allergen Labeling– It is very important that you clearly state any of the 8 major allergens that are in your product. They include Milk, Eggs, Fish, Shellfish, Tree-nuts, Peanuts, Wheat and Soy.   Double check every ingredient that goes into your product to make sure they don’t have hidden allergens (like dry seasoning blends that may have soy or nut powders in them). Just check out the FDA recalls and you will see how many products are recalled almost every day for accidently not listing an allergen.   By the way—coconut is considered an allergen in the U.S.A., and Canadian allergens include sesame seeds and mustard.

Serving Size– Unfortunately, your 1-lb muffin that delivers 9 grams of protein is not an honest serving size! The FDA has what is called RACC (Referenced Amounts Customarily Consumed) and they say a normal muffin size is 55 grams (that’s about 2-oz). You may not consider this a portion, but the FDA does. Watch your sizes and base your nutritional information on what is the reference. Its all right here in Title 21 of the CFR part 101.12

All Natural? The FDA does not have an actual definition of “all-natural” and there have been plenty of class action lawsuits. The rules are vague and there are lots of ingredients that may seem natural- like modified food starch and alkali processed cocoa- that are not. You have to figure that if big companies like Trader Joe’s and Ben and Jerry’s are getting sued then you can get in trouble too. Your best bet is to just stay away from the “All Natural” term. The All Natural terminology is just so 10 years ago anyway- try to focus on other ways to market your product in a more measurable and certifiable way (Gluten Free, Kosher, Organic—etc)

Net Carbs– This is a made up word used to indicate the total number of carbohydrates minus soluble fiber and sugar alcohols. The term is not based on sound science and can give consumers the false impression that they do not contribute any calories or raise blood sugar levels. The FDA has not has not yet taken a position on words like “net carbs” on your food package- however they will evaluate labels on a case by case basis to ensure that the brand owner is not “characterizing” the amount of carbohydrates in a product. For example saying your product “ONLY” has 5 carbs per serving is characterizing it—you are doing more than just stating the facts. If you do want to market your product as having a lower carbohydrate level and imply that it will help with weight loss, be very careful of your wording and run your final statements by a regulatory lawyer expert!

Keep it real- I know that all food entrepreneurs have the best of intentions and want to make sure that their creations are healthy and clean. However, there are many tempting and alluring food science shortcuts that will make your product taste great or last longer on the shelf… but can all of a sudden make your product not as “real” or as “clean” as you want it to be. Don’t try to hide what you are doing! If you are going to jack up your fiber levels with soluble corn fiber then just put it on the label and fess up! Calling your natural flavors as “extracts” is not fooling anyone (ok maybe it is, but you know deep down that you are misleading!) -Don’t try to downplay your protein sources or bacteria inhibiting preservative levels.

Before you put your product on the market have the entire package reviewed by a regulatory lawyer or food scientist. Hidden mistakes can result in millions of dollars lost as well as your brand name reputation.

 

Comments?

Happy New Year!

To all those who are receiving this newsletter— I want to start off by saying thank you for signing up! I also may have added you to this list if you have downloaded my book or worked with me in the past.

About a year ago I asked potential future readers of this newsletter or blog what they would like to read about– what food science topics they would like to hear more on! I want to continue this dialogue and ask that everyone either email me directly (rachel@theintrepidculinologist.com) or post a comment on this blogs link about what you would like to hear more about.

I have been writing blogs for years and posting them either on this site or on other similar industry websites- but I sometimes run out of ideas so am looking forward to you sending over your requests-even if its just a simple question, knowing me and my obsession with this topic– a essay can be written on any question presented to me!

Looking forward to hearing your questions and topic requests for 2015!

Rachel

 

PS- The Fancy Food Show is coming up – San Francisco next week– are you going??

www.specialityfood.com 

As a food scientist, I often have to break traditional rules of flavor in order to fit our product into a can, box, plastic tray and pouch. The traditionalist chef inside of me however starts protesting loudly when I bend the rules too much, to the point where my newly developed food item only loosely resembles the original origin and flavor of the dish. This is why it is important for us (the culinary scientists) to be well versed in both the science and culinary aspects of our food. While maintaining flavor is important, keeping our processed foods safe is crucial! The growth of dangerous pathogens like E.coli and C. Botulium must not only be prevented, but if they are present in the raw ingredients at low levels, must be killed off immediately!

In my early working days I had the great pleasure of setting up regular challenge studies for shelf stable salad dressings (translation: inoculating food with bacteria to see if the counts increase, decrease or stay the same) My boss, a hard core food microbiologist informed me that if the bacteria did not die off immediately, the product would fail and the R&D developers would have to jack up the preservative levels. Known as the bacteria police force, our agar smelling department was not the most popular group in the house. It was our job to advise the developers on acid and preservative usage, to prevent the outgrowth of pathogens and spoilage organisms. The acidity kept the product below 4.6, preventing pathogenic outgrowth, while the second battalion of preservatives killed off all the spoilage organism like lactobacillus, yeast and mold. If a salad dressing company can sell their product at a higher cost, refrigeration is another viable and more natural option for spoilage inhibition. Refrigerated products don’t need preservatives and will have a fresher final taste and cleaner label.

Most dressing-like products are cold filled in order to maintain the integrity of the emulsion. Hot fill methods (heating to 160’F for products under pH 4.6) can be used to kill spoilage organisms in durable non-emulsion style acidified products such as marinara, pizza and BBQ sauce. These products can maintain their identity even after being heated to 160’F and is shelf stable in its final form. The positives in this case are a lower cost shelf stable product; the negatives are a product that has been heated to a higher temperature which could loose some of its valuable flavor.

But what about products that are only acceptable at pH levels above 4.6 like beef stews, tuna fish, alfredo sauce and creamed corn? At this point, a flavor compromise must be made. Without the preventative measures of pH in place, there are only two other options. Heat the heck out of it or spend the extra money to have a refrigerated or frozen product with a short (and expensive) shelf life. Thermal retorting, which involves heating the food to 250’F + kills every living thing that ever lived in that food product. Processing specialists determine the minimum heat needed to kill everything up to the most difficult bacteria to kill in the can. End result is your typical jar or can of processed food. Heated to the point of total flavor loss, the food industry has done wonders to get those flavors back in there-however, we do have to adjust our standards to accept these products by names that they really might not be entitled to.

Bacteria is controlled by heat, acid, refrigeration and preservatives. The developer’s best tools are understanding bacteria growth and the means that can prevent it. The chef can help the scientist understand at what point the product will be so off the charts that it will be an insult to the original dish itself. The scientist can make sure that the company budget and manufacturing capabilities matches their bacterial prevention system. Working together the chef and the scientist can balance it out perfectly.

label claim pixI get calls from lots of start up companies asking me how they can keep their label “clean” and ensure that their product has no preservatives, is all natural and uses fresh local ingredients—oh and they also want it to be affordable and shelf stable too!

Everyone wants their product to hit all the current trend buttons (natural, clean label, locally sourced, GMO Free, etc) – but sometimes you have to compromise in order to ensure that you are creating something that is both safe and affordable- and it also helps to understand that just because something sounds like it is not natural, doesn’t mean that it isn’t!

Lets start with mold inhibitors- anyone who wants their somewhat moist baked good to last on the shelf is going to have to keep the fuzzy stuff at bay –and there are a wide variety of natural and synthetic versions. Potassium Sorbate for example is a great yeast and mold inhibitor that is inexpensive and works in a wide variety of pH’s and food bases- it’s not natural but it does the job! Sodium benzoate is also cheap, synthetic and keeps the bad bacteria at bay! There are more natural options that you can use- and they are called cultured dextrose- (Danisco sells a trademarked version of this) – It’s a cleaner label bacteria inhibitor that is created via fermentation of milk and sugar with probiotic organisms and works in a wide variety of applications like salad dressings and cured meats, soups and dairy products. They cost more but allow you to maintain a “natural” statement on your label (assuming all other ingredients are natural as well). Of course you can always cook your product (IE canned foods and jarred shelf stable sauces often just rely on heat as a the preservation method) or dump in tons of salt or sugar- those too can inhibit bacteria by lowering the water activity of the product.

What about flavorings? No one in the specialty food industry wants to put artificial flavor in their products and that is understandable but keep in mind that natural flavors are more expensive and less concentrated than artificial so you need to use more of them to get a flavor impact. If you want to flavor up a lemon cake- you may only need 0.02% artificial flavor but would have to use 2 to 3% of a natural flavor to get the same effect—AND that natural flavor is going to cost you more money. So what can you do? You can use a flavor called WONF (with other natural flavors) which is a blend of similar flavors used to make up the flavor you like but at a slightly reduced cost- you can tell your supplier that you want an “off the shelf” flavor that they may already sell to several companies (a stock flavor) that they probably produce in bulk at a cheaper price. Talk to your flavor supplier about options!

Even starches can fall in the natural or not natural category—If a starch is referred to as a “modified food starch” it is not a natural thickener—you need to ask your supplier to provide you with a natural “unmodified” food starch. There are also other ways to thicken a product like via dehydration or evaporation of water—using tomato paste (if your product is tomato based), or experimenting with gums and hydrocolloids. There are always natural alternatives in the world of food ingredients, it’s just a matter of balancing out what you need with the right price point.

Last year I wrote a blog that debunked and clarified some Thanksgiving myths. At the time, not too many people were reading my blog and I feel like I don’t want my hard research to go to waste on the three people that may have read it-so I am going to cheat alittle bit and repost my last year Thanskgiving blog, but to be fair will throw in a few extra tidbits for 2014!

The holidays are coming up and all of a sudden everyone is a food scientist and knows all about tryptophan, proper turkey thawing, the best raw ingredients to use for pumpkin pie, and the accuracy of pop-up thermometers. Will the real chefs and culinologists please stand up? It is your job to stop the false rumors and annoyingly educate your family and friends with your official, technical and documentable knowledge!

Pumpkin pie ingredients. While all my organic northern California friends are gently cooking and pureeing down their farmers market pumpkin, I recommend taking the easy way out. Call your local Stahlbush representative and ask them nicely if they will send you a sample of their gorgeous bright-orange frozen pumpkin purée. Be honest, tell them you want to make it into a pumpkin pie and offer to pay for the overnight shipping.

 I snagged a few lbs of Stahlbush sweet potato puree and pumpkin puree and am looking forward to mixing it with curry and coconut (one of the McCormick and Seasoning company’s flavor pairing profile recomendations) and making a a creamy vegan soup! I might even acidify it, file it with the FDA and manufacture it someday!

Tryptophan myth. After the big meal, everyone loves to crash out and blame it on the tryptophan. Unless you ate the entire turkey yourself, there is really not enough tryptophan in turkey to cause post-feast sleep. The real reason everyone is tired is because they have been dealing with food, family and football all day! Tryptophan is an essential amino acid and can be found in lots of foods, not just turkey.

Proper turkey thawing. I don’t care what anyone tells you: Do NOT thaw your turkey on the counter! It will take a long time (more than 2 hours) and parts of the defrosted bird will be in the TDZ (temperature danger zone) of 40° to 140°F for several hours allowing pathogenic bacteria to pick up where they left off before the freezing and grow to harmful levels! There is lots of bad advice out there, but I trust the USDA Poultry Preparation Consumer Guide and I recommend that everyone at least skim through it and try to follow their ultra-conservative guidelines.

Please turkey eaters, don’t think you are immune to food borne disease. I don’t care how clean your counter is, if you defrost all day on the counter-you could get people sick. Everyone always blames the manufactured retail food world for not being safe, but the retail market is one of the safest, its the home cooks, canners and chefs that cause the most gastrointestinal damage with careless behavior!Pop-up thermometers. I have no idea if they really work or not but considering that they are mass-produced and stuck into thousands of turkeys, chances are they are not the highest quality or most accurate meat thermometers on the market. If you rely on these pop ups, you risk undercooking (and making people sick) or overcooking (how embarrassing!) your turkey. I say, splurge on a good meat thermometer that will help you make a safe and delicious turkey!

I attended a foodbuzz event this year and they gave me a big schwag bag-and in that bag was a really nice thermometer to monitor the internal temperature of my bird. I have moved beyond the pop up, you should too!

Have a Happy and Safe Thanksgiving!

How To Eat Fried Worms

Remember that book  “How To Eat Fried Worms” by Thomas Rockwell (1973) – the kid who accepts the bully dare and eats 15 worms over 15 days—making them taste better by adding ketchup, mustard, and other condiments to it.  Eating insects has never been a mainstream thing to do in the U.S. and it usually falls under the dare category – like the deep fried seasoned cricket I ate at the RCA conference a few years ago, or getting the worm in the tequila.

But the whole insect acceptability thing is changing! I went to a San Francisco meet up group a few weeks ago- the topic was “Alternative Proteins” and I saw that Hampton Creek was there- who has been in the food news lately because they are creating an egg alterative using pea protein and other non egg ingredients. Eggs that are not made from Eggs because real eggs contribute to cholesterol and comes from chickens that live in crowded spaces.

But Hampton Creek was not the star of this event—the real excitement was the three companies showing their cricket based food products.  Tiny Farms, EXO  and Chirp . Exo just raised $54,000 on kickstarter and have created (but not sure if yet selling) their all-natural cricket bars made from protein flour. Chirp is raising organic crickets and making products from the cricket flour. Tiny Farms wants to feed a growing world by developing a ready supply of  sustainable and nutritional edible insects.  So overall, the goal is to grow crickets, make them into flour and use the flour to create high protein and possibly paleo food products. Cricket protein also has omega-3’s, iron and calcium.

The meet up event was packed and everyone was eating cricket muffins, cricket caramels and cricket EXO bars.  I ate some of the energy bar and tried the muffin but had a hard time getting myself to eat the meal worm candy – probably because I could see the meal worms face right there, protruding from the candy- and just couldn’t do it!

Are insects vegetarian?

Are insects vegetarian?

But as a food science consultant I need to come to terms with this—its just a matter of time before the industry (or at least the bay area) will be exploding with cricket flour based food companies and they will need help developing their products. As a consultant – I have to be accepting of all kinds of foods- cricket food, marijuana infused food— as long as they follow the basic food safety guidelines that the FDA has so clearly written up in the code of federal regulations– then all is good!

I have a few concerns about working with crickets- not even sure if the FDA has or will be addressing these any time soon!

  1. Cricket manufacturing facilities need to follow the same GMP’s as other food plants – are they being inspected?
  2. Cricket skeletons may be considered an allergen –like shellfish, will the FDA have to amend their allergen listing
  3. What will the crickets be fed and how can we ensure that the feed is clean and won’t somehow have a negative effect on the people that eat the crickets? I know it sounds fine that organic crickets will be happily feeding on fruits and vegetables but where does that supply of cricket feed come from and who is going to monitor what the cricket is eating?
  4. Will the crickets be treated humanely? (this came up during the meet up discussion— don’t crowd too many crickets into one space!)
  5. Will co packers manufacture products using cricket flour—will they have special labeling for it  (allergen labeling?)

My fellow food scientists are discussing this on the IFT linked in group – so join in and read what they are saying! I am already thinking about how to get the max amount of protein from the cricket itself—right now, EXO bar only has 10 grams of protein in a 290 calorie bar- and each bar contains 25 crickets-as well as other nuts. I want to figure out a way to really shove more cricket protein in there- like lets make a shelf stable retorted protein drink with 100 calories and 21 grams of cricket protein that is heavily flavored up with chocolate, coffee and berry flavors and boosted with caffeine- the opportunities are endless!

Chirp Chirp!

chapter 12 nutriton label pictureSometimes… well actually most of the time- I get calls from start ups asking me how they can scale up their recipe to industrial size. The first thing I always ask —is your formula in percentages because that’s what manufacturers need to see it in.

Crickets chirping in the distance— silence on the line…

Client usually says  “I measure my liquids with a measuring cup and I use teaspoons to weight out my salt and sugar- is that ok??”

I answer NO!! A recipe and a formula are not really the same thing (although they are often used interchangeably) – a recipe is what you make in your house, and record your amounts in cups, tablespoons and pinches. A formula is how a professional specialty food manufacturer will document your information and is based on pounds, kilograms, grams and other weight measurements. These weights are then converted to percentages so any amount or batch size can be made on those confirmed percentages.

This means that if you have 2 cups of water in your recipe you have to weigh it out—and 2 cups of honey will not weigh the same amount as that water, and a cup of corn syrup will also have a different weight. This is because all these ingredients have different densities. The density of water is 1 gram per 1 ml (volume) but the density of honey is about 1.4 gram per 1 ml (volume) and different types of honey even have different densities!

Here is a sample of a simple conversion of a homemade recipe to a professional industrial formulation

Typical Chocolate Chip Cookie Recipe Recipe Converted to Weights (Approximate)
2-1/4 cups All Purpose Baking Flour 320 grams
1-teaspoon baking soda 4.8 grams
1-teaspoon salt 6 grams
1 cup (2 sticks butter) 227 grams
¾ cup granulated sugar 151 grams
¾ cup packed brown sugar 165 grams
1teaspoon vanilla extract 4 grams
2 large eggs 97 grams
2 cups chocolate chips 303 grams
1 cup chopped walnuts 122 grams

Final Formula in Percentages

Ingredient Recipe in Grams Percentage
Flour 320 22.86%
Baking Soda 4.8 0.34%
Salt 227 0.43%
Butter 6 16.22%
Sugar 151 10.79%
Packed Brown Sugar 165 11.79%
Vanilla 4 0.29%
Eggs 97 6.93%
Chocolate Chips 303 21.65%
Walnuts 122 8.72%
Total Weight 1399.8 100.00%

 Its very simple math- you just need to keep in mind that in food science manufacturing world, there is no such things as a cup, spoonful, pinch or feather dusting— everything has to be in weight only!

 For more useful start up food company technical information- check out my book—- 

www.theintrepidculinologist.com 

Its official I no longer have to buy my own cheeses and make a party platter- I discovered LASSO at the Food Fete party this week and they will take care of everything for me- the wine, the cheese and more! They also told me that anyone who reads this blog can get $20 bucks off their next order at www.lassoit.com (minimum order $60 but still …. its a good deal!) I am all about simplifying my parties—-

$20 bucks off--same day delivery!

$20 bucks off–same day delivery!

This was just one of many interesting items that I got to taste and experience at Food Fete– the post fancy food show special party for food companies and the media!  We all meandered around the room sipping Prosecco from Italy  and tasting gourmet chocolates made by a company that is known for making the kitchen sink….(Kohler). Other specialty items included the all american couture unique chocolates from Jcoco- (Edamame and Sea salt and quinoa) and more chocolate from Seattle Chocolates (their parent company) a responsible company that uses ethically traded cocoa. New from Manchester Farms were Quail Eggs and boneless quail – so you can make mini scrambled eggs whenever you want.

IMG_6614 IMG_8733

I love nuts — so was excited to see that Sante- a company that sells roasted and seasoned nuts is making unique flavors like chipotle almonds, cardamon cashews and sweet and spicy peanuts.

Thanks to all these companies for coming out to San Francisco and showing us all the new and exciting products that we can now buy- so much variety and so little time!

IMG_8742