For those of us who have been confused as to whether or not almond milk contains actual milk, the Food and Drug Administration under Trump’s leadership is here to help. According to the FDA commissioner, Scott Gottlieb, the agency is planning on announcing a new guidance on the proper use of the term milk. In his own words,

If you look at our standard of identity—there is a reference somewhere in the standard of identity to a lactating animal…And, you know, an almond doesn’t lactate, I will confess.”

If only all confessions were obtained so easily!

Standard of Identity

So what is standard of identity? These are regulations set by the FDA that dictate what a food is, may be called, and the ingredients that must be used, may be used, or must be listed on the label. Standards of identity don’t actually have anything to do with the quality of a product, though they do help protect against fraudulent versions of a product.

A great example of the standard of identity laws at work is Kraft Singles. These marvels of engineering are legally not allowed to be called cheese, as they are not made with at least 51 percent real cheese. Until 2002, Kraft Foods labeled them as Kraft Singles Pasteurized Prepared Cheese Food until that name also ran afoul of the FDA standard of identity for cheese food due to the inclusion of milk protein isolates. They are now sold under the name Pasteurized Prepared Cheese Product.

Related: Homemade Vegan Nut Milk Recipes

Vegan Disruptions

There is a benefit to being able to set standards for what a product is. No one wants to bring home a package labeled cheese and open it to find Kraft Singles (cheap shot…sorry). But the way we eat has evolved rapidly, and what seemed ridiculous twenty years ago is now a worldwide phenomenon followed by more than a million people in the United States. When the FDA set into place the standards of identity, they did not forsee veganism.

The most notable disruption of these standards as of writing this occurred in 2014. Scrappy startup Hampton Creek, makers of popular vegan mayo Just Mayo, was reprimanded by the FDA for violating the mayonnaise standard of identity. Those circumstances are markedly different than these, as the FDA has not singled out a single specific company (likely because large businesses like Unilever haven’t complained this time).

There is still an important parallel between the two cases. Both of these products, vegan mayonnaise and non-dairy milk, threaten animal product industries struggling to cope with modern societies desire for plant-based foods and the fallout from their own unsustainable practices. In 2014, Just Mayo inadvertently capitalized on an egg industry reeling from an avian flu season that claimed nearly 40 million chickens. Meanwhile, a dairy industry in decline has been complaining about the use of the word milk since 2017, going so far as to recruit thirty-two members of Congress to advocate for them. In both of these cases, it appears that business is asking the government to step in and deal with this disruption for them.

Well Established Relationships

Based on the folksy, vaguely patronizing soundbite from the commissioner, it seems likely the FDA will come down on the side of the dairy industry. This is to be expected, though. The Trump Administration has proven itself to be extremely friendly to big business.

Gottlieb has been publically approving of big business friendly moves in the past. When the USDA moved its branch of the Codex Alimentarius Commission, a collaboration of more than 180 countries responsible for international food safety standards, he was among those to publically congratulate USDA head Sonny Perdue. While it might sound like a great idea to have the U.S. Codex Office housed at the USDA, that move leaves the national positions on food safety open to manipulation by big food producers. Internationally, this causes the rest of the world to become increasingly mistrustful of our science and safety regulations as well as our ractopamine-laced pigs and chlorine-washed chickens.

Related: Best Cooking Oils – Health benefits, Smoke Point, Which to Use and Avoid

International Agreement

But international food governing bodies are in agreement with the dairy farmers here. In fact, the EU ruled that items labeled milk, butter, cheese, cream, and yogurt must contain animal milk. A label clarifying the products plant-based origins will no longer suffice. Except for coconut milk…and almond milk…and cream filled sweets. There is also room for exceptions to the rules.

It feels almost like a punishment for soy and vegetable products clearly labeled tofu butter and veggie cheese. Will the person purchasing these products be disappointed there is no milk or butter? They clearly don’t mind the tofu or veggie part.

Related: Hellmann’s Vs. Just Mayo – The Very Interesting Battle Within the Mayo Industry

At the same time, not everyone is informed when it comes to non-dairy alternatives. Soy milk and vegetable cheese are also fundamentally different from dairy milk and cheese, and that separation could have unintended benefits for vegan and non-dairy products. The EU no longer accepts certain animal products from the U.S. due to our lax animal welfare standards. Perhaps the FDA, in their desire to appease the dairy board and catch up with other worldwide legislation, are doing vegan companies an early favor.

Who Is Confused Here?

Vegan alternatives are everywhere. Removing the word milk from non-dairy alternatives won’t change the growing demand for them.

Here’s the biggest question. How are these products supposed to be labeled, and should their non-vegan counterparts be anywhere near that decision?

The real problem here is not the label.

Sources:

• “An almond doesn’t lactate:” FDA to crack down on use of the word “milk” – Ars Technica
• Standards of identity for food –Science Direct
• Kraft American Cheese Singles Have Been Labeled A Health Food By Professional Nutritionists (Not As A Joke) – Huffington Post
• Hellmann’s Vs. Just Mayo – The Very Interesting Battle Within the Mayo Industry – Organic Lifestyle Magazine
• A Food Fight Has Broken Out Between The USDA And FDA – Five Thirty Eight
• EU court bans dairy-style names for soya and tofu – BBC

The FDA is considering restricting the use of the word “milk” to mammal’s milk. This would non-dairy milks like soy, almond, hemp, and coconut milk producers from referring to their products as “milk.” The National Milk Producers Federation has been asking the FDA to end the use of the word “milk” in non-dairy milk products since 2000, according to AP.

Mammals produce milk, plants don’t.” – Jim Mulhern, president of the National Milk Producers Federation

Related: Homemade Vegan Nut Milk Recipes

According to PBS, FDA Commissioner Scott Gottieb says that if the FDA decides to end the use of the word “milk” by non-dairy milks, the FDA, in about a year, will probably start by notifying non-dairy milk companies of the possible change and seek public input. Scott also says that the FDA would likely face lawsuits from the non-dairy industries, and adds that the dictionary definition of milk does include milk produced from nuts.

Related:

• Hellmann’s Vs. Just Mayo – The Very Interesting Battle Within the Mayo Industry
• How to Avoid GMOs in 2018 – And Everything Else You Should Know About Genetic Engineering
• Best Cooking Oils – Health benefits, Smoke Point, Which to Use and Avoid

Sources:

• The Milk Project – Ashleys Green Life (image)
• The government wants to ban soy and nut milks from being called ‘milk’ – Business Insider

Aluminum is an adjuvant used in vaccines licensed by the US Food and Drug Administration. James Lyons-Weiler, Ph.D., wanted to know how did the FDA determined what the safe levels are for aluminum in vaccines.

For most of my adult life, I never gave vaccine safety a second thought. Sure, I spaced my sons’ vaccines out, and none of the pediatricians in three states gave us a hard time. We were never kicked out of practice because we exercised our rights to choose if, how, and when to consume vaccine products.

But after writing a chapter on vaccines in one of my books, I grew increasingly concerned about whether something, or somethings were very wrong with my understanding of vaccines and how they were developed.”

Dr. Lyons-Weiler’s LinkedIn profile states that he is a long-time veteran in the areas of genomics, proteomics, bioinformatics and evolutionary biology. “He earned a Ph.D. in Ecology, Evolution & Conservation Biology, and won a US DOE/Sloan Postdoc in Computational Molecular Biology at Pennsylvania State University…”

Related: A Look At the Flu Shot in 2018

Dr. Lyons-Weiler’s published a study, Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum, that says the recognized safe aluminum levels in vaccines are based on immune efficacy and ignore body weight. James says that several critical mistakes have been made in the consideration of pediatric dosing of aluminum and that safety inferences of vaccine doses of aluminum have relied solely on dietary (ingested, not injected) exposure studies of adult mice and rats.

On Day 1 of life, infants receive 17 times more aluminum than would be allowed if doses were adjusted per body weight.

The FDA states that 850 mcg of aluminum is safe for an adult. With his research, James found that a series of errors led to the guidelines that state 850 mcg of aluminum is safe for an adult.

The first serious problem (Problem #1) is that a provisionally tolerable weekly limit assumed to be safe was, by a series of errors and bad assumptions, transformed into a daily limit that appeared to be backed by studies. The studies used were not up to date, and the FDA’s determination used spurious estimates to transform safety information from dietary studies of adult mice into injected safe limits in human infants. These errors were made, in part, in the pediatric limit consideration by the FDA, who used outdated information not consistent with other organizations like World Health Organization.

To add to the confusion, the 1 mg/kg/week was also then changed to 2 mg/kg/week. The ATDSR used information from one study, assumed 1 mg/kg/week, adjusted using arbitrary functions that are without a doubt as good as a bad guess.

The provenance of these errors is reviewed further below, and in our newly published study.”

Related: How To Detoxify and Heal From Vaccinations – For Adults and Children

We came across this study last week on Medium. It has since been deleted, along with Jame’s account. We checked on web.archive.org to see if the page had been preserved; it had not. We searched Google, but it’s gone from search results, but we did find the article republished by James on LinkedIn.

This Open Letter originally appeared on Medium.com. Due to their censorship, it is ported here.= JLW. It is based on peer-reviewed studies.” – Dear FDA: Please Reconsider “Safe” Levels of Aluminum…

We also noticed that Jame’s Medium account has been suspended. And Bing is a little slower to eliminate the search results. If you want, click here to see their Cached version while it’s still available, but you can also read the full article republished on LinkedIn.

Related: Doctors Against Vaccines – Hear From Those Who Have Done the Research

The Food and Drug Administration has announced a new risk-based approach to regulating homeopathic medicines with an increased focus on products administered by injection, intended for children or the elderly, and those marketed for serious diseases. Per the Dietary Supplement and Health Education Act of 1994, homeopathic medicines will not need FDA approval to be on the market, but this proposal brings an increased level of inspection to the 3 billion dollar homeopathy industry.

Among other reasons, these guidelines have been introduced shortly after the discovery of inconsistent amounts of belladonna (otherwise known as deadly nightshade) were found in teething tablets, causing 400 injuries and 10 deaths.

NBC News reported that when Little Blaine Talbott started teething, his mom, Karina, saw homeopathic teething tablets in the store, she grabbed them. “It said homeopathic, all natural, you know, organic stuff, and so you think that stuff is going to be safe for your child.” Coon Blaine began having seizures. Neurologistsdidn’t know what was causing them, but the seizures stopped when Karina ran out of the tablets.

Supplements the FDA Will Focus On

While the FDA has made it clear they will not be changing the way the majority of homeopathic are regulated, some medications have been put on notice. These include

• Products that have or are associated with a history of manufacturing errors, adverse health incidences or other safety issues
• Products with infectious agents, controlled substances, and potentially toxic ingredients
• Products administered through non-oral or non-topical method, such as injection
• Products meant to treat serious diseases such as cancer, heart disease, or addiction issues
• Products aimed at children or elderly populations
• Products that have been altered or where the strength, quality, or purity differs from established standards

Mild or Truly Terrifying?

It is possible to see this as the end of being able to treat yourself in the way you see fit. There is some truth in that, and as Americans being told what we can or can’t do is unsettling. “It’s a slippery slope…” But the good news is that this is on the mild side of medication regulation, and there is certainly an argument made for a greater level of regulation – with the right intentions. The FDA has released guidelines, as opposed to hard and fast rules. It’s entirely possible that many supplements will be left alone. If we learned one thing from Nestle’s recent acquisition of Pure Encapsulations, Garden of Life, and Douglas Labs, supplements are big business, and our government is extremely friendly to big business, which brings up the other possibility. We can see a future where large supplement manufacturers, of whom put the profits over our health, could ruin the health of the natural health industry.

Sources:

• FDA takes more aggressive stance toward homeopathic drugs – Washington Post
• Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry – FDA.gov

How much would a chocolate company pay to know exactly when you or the lady in your life is experiencing PMS symptoms in an effort to more effectively target ads? If that level of corporate involvement in your medical records upsets you, you’re not going to like the new digital ingestion tracking system approved by the Food and Drug Administration.

This new tracking system is designed to address the issue of nonadherence, where patients do not follow through on prescribed medical treatments. The treatment, in this case, is called Abilify MyCite and it’s made by Japan-based Otsuka Pharmaceuticals. The actual medication portion of the Abilify MyCite system is brand-name aripiprazole, an antipsychotic drug used for treating schizophrenia, bipolar disorder, and as an add-on treatment for depression in adults. “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

How It Works

The pill part of the system is the simple part. Abilify MyCite comes with a web-based dashboard that allows a patient to track their actual drug ingestion, daily activity level and self-reported mood and sleep. The sensor that tracks that is roughly the size of a grain of sand and activates upon contact with fluid in the stomach. It detects and records the date and time the pill was taken and relays that to a patch worn by the patient. The patch then sends all of that to the patient’s smartphone. When the patient gives consent, caregivers or medical professionals are able to see all of this data, though the system does not register the ingestion in real time or emergencies. The patient is able to revoke those permissions at any time.

Is It Worth It?

The system itself does not actually increase drug compliance. Both Otsuka Pharmaceuticals and the FDA take care to note that the product does not fix nonadherence, and it remains to be seen if the patients with the first illnesses targeted by this medication will respond positively. While nonadherence is an expensive issue, schizophrenics and those with bipolar frequently skip medications because they don’t like the way they feel when on them or dislike the feeling of being controlled or manipulated. A pill that tracks their compliance is probably not going to change that.

Who Does This Product Work For?

Imagine a system where medical compliance is a condition of benefits without a way around it. Can a digital ingestion tracking system create a situation where your insurance charges you more for choosing not to take a prescription?

The more connected we become, the more difficult it is to keep information private. How secure will this data be? According to Kimberly Whitfield from Otsuka Pharmaceuticals public relations department, “the data is encrypted while it is stored in the Health Insurance Portability and Accountability Act (HIPAA)-compliant cloud environment, and the cloud service provider does not have a decryption key.” While all of these makes this information much more secure than your average social media profile, information leaks happen across every sector.

The company is clearly taking precautions, but can the information be stopped once it’s out there?

Recommended Reading:

• How to Detoxify From Antibiotics and Other Chemical Antimicrobials
• How to Kill Fungal Infections
• Three Homemade Toothpaste Recipes – Better Oral Health for Less Cost

Sources:

• FDA Approves First Digital Pill That Can Track Whether You’ve Taken It – NPR
• FDA approves pill with sensor that digitally tracks if patients have ingested their medication – FDA
• FDA approves ‘trackable’ pill – BBC
• Experts raise eyebrows at digital pill to monitor patients with schizophrenia – Ars Technica

“Meat” grown in a lab is a hot trend right now, with manufacturers jumping over each other in a quest to be in on the next big food craze. Scientists, environmentalists, and entrepreneurs are extremely excited by the prospect of meeting the world’s growing demand for meat with only a fraction of the resources needed by our current factory farming system. One company, Impossible Foods, has been carried away in that excitement. They began selling their soy leghemoglobin derived Impossible Burger in 2016, despite not being generally recognized as safe by the Food and Drug Administration.

Putting Sustainability First

Cultured “meat” is an enticing proposition. The Impossible Burger uses 95% less land, 74% less water, and creates 87% less greenhouse gas emissions than its cow-sourced counterparts. It’s also free of antibiotics, artificial ingredients, and hormones. This particular cultured meat is made from soy leghemoglobin genes and a genetically modified yeast not unlike that found in common Belgian beers.

Leghemoglobin is a hemoprotein found in the root nodules of leguminous plants – in this case, soy. Once these hemoproteins are broken down, they release heme. Heme contains iron and carries oxygen in the blood, making the veggie burger “bleed” and giving it a meaty texture and flavor. Making the burger entirely out of these root nodules would be expensive and would increase its negative environmental impact, but Impossible Foods, the company behind Impossible Burger, combines the soy leghemoglobin gene to a yeast strain and then grows the yeast via fermentation.  

Can You Eat It?

Sustainable? Yes. But is it safe?

Impossible Foods says yes. The burger has been reviewed by a panel of experts, with scientists from the University of Nebraska, University of Wisconsin and Virginia Commonwealth University generally recognizing it as safe. Rats studies have been conducted, and there were no adverse effects from the soy leghemoglobin protein, even when feeding the rats 200 times the amount a human is expected to consume.

But the magical yeast that allows the company to produce their burger causes other problems. There are more than 40 other unidentified proteins in the impossible burger. In the words of Michael Hansen, a senior scientist at Consumer’s Union, “It’s only 73 percent pure, the other 27 percent is from proteins from the genetically engineered yeast that produces it, and these [proteins] have an unknown function…” Due to these unidentified proteins, the FDA told Impossible Foods that the burger was unlikely to be recognized as safe.

What is Progress?

The Impossible Burger has been available at select restaurants since 2016. Impossible Foods does not need the FDA to categorize the burger as generally recognized as safe to sell it. This isn’t actually illegal, as the FDA’s self-affirmation program does not require new ingredients to be approved. We only have any of this information because Impossible Foods tried to go one step further in the regulation process, applying for the FDA’s GRAS (generally recognized as safe) status.

Impossible Foods has a mission, and that mission is an admirable and necessary one. Forget about figuring out if it’s real or not, climate change is here. Factory farming is not sustainable, even as the demand for meat is still growing. More consumers are looking for quality sustainable or vegan/vegetarian options, and Impossible Foods wants to serve that market. Their website emphasizes their sustainability.

They also make a point to push transparency and encourage questions. That will be crucial for a generation that is looking for corporations to step in where the government is not addressing their needs and concerns.

The food system has to change or it will collapse. Many companies have been stepping up their environmental bona fides in response the Environmental Protection Agency’s current irresponsibility. It remains to be seen if the FDA can cope with the demands of the rapidly evolving demands and realities of a sustainable food system. 

Sources:

• Impossible Burger’s ‘Secret Sauce’ Highlights Challenges of Food Tech – NY Times
• Untested GMO Ingredient Illegally Sold Without FDA Approval – Cornucopia Institute
• Frequently Asked Questions – Impossible Foods
• Silicon Valley’s Bloody Plant Burger Smells, Tastes And Sizzles Like Meat – NPR

The answer to an age-old question in advertising used to be simple. Got milk? Yes, America answered. But that is not our new reality. The question remains the same. The answer now? What kind of milk?

Milk is no longer something your local milkman drops off in a crate on your front porch. Milk comes in many different varieties. There are dairy versions like cow, goat, sheep, or buffalo (though the last two milks usually end up as cheeses). If you’re vegan or lactose-intolerant, there are options like almond milk, soy milk, coconut milk, rice milk, hemp milk, oat milk, pea milk…yeast milk? At this point, it’s safe to say milk is a both a universal and incredibly niche item. Cow milk is everywhere, but if you know where to look, the options magically open up.

Protecting the People from Reading Labels

More than thirty congressional members have signed a letter to the Food and Drug Administration to ask that the FDA take “appropriate action” in regards to milk labels. While their idea of appropriate action is not specified in the letter, it’s clear that the dairy industry considers plant-based milk products a threat. Unfortunately for the current food establishment, this is not the first or last time customer demand will force them to adapt or die.

Americans are eating less meat. They’re more environmentally conscious. Allergies are also on the rise, and more people are beginning to see the correlation between what they eat and their overall health. Half of Americans consume non-dairy milk, and over one-third of them are open to plant-based eating in general. This is naturally going to open up the food market for healthy competition from alternatives to traditional meat and dairy. The “appropriate reactions” from big food companies so far have been to run to the FDA, claiming a product label like almond milk has the potential to fool customers into thinking they are buying dairy milk. Another example is Hellman’s Mayonnaise claiming consumers needed to be protected from vegan mayonnaise because it isn’t “real” mayonnaise.

Is This the System We Want?

Large corporations often handicap their competition while pretending to play the part of the consumer’s champion. Pay no attention to the fact that the vegan mayo behind the curtain is serving a growing population looking for healthier and more environmentally friendly options while egg costs have never been higher. You, the consumer, have been wronged by their confusing label. The language in the letter to the FDA from dairy state congressmen seems altruistic…until you realize they have claimed the consumer is not capable of reading a label. Why on earth does this box of milk have almonds on it? This is sooooo confusing!

Consumers have more access to information than ever before, and they’ve changed. Questioning the status quo is now the thing to do. Tactics like letters released and lawsuits filed over “misleading labels” are a system that believes people aren’t able to see the bias, and it’s also one of the reasons these industries are floundering right now. Consumers want healthier options and product accountability. Hellmann’s may have figured something out… their new vegan mayo line launched in 2016, 2 years after they tried to shut down Just Mayo.

Further Reading:

• Hellmann’s Vs. Just Mayo – The Very Interesting Battle Within the Mayo Industry
• Cheap and Easy Detox Diet Plans (and more)
• 6 Food Industry Tricks You Don’t Know About

Sources:

• Dairy Industry has a Cow over Plant-based Milks – Grist.com
• Your Breakfast is About to Take a Weird Turn – Mother Jones
• Welch-Simpson Letter – National Milk Producers Federation
• Vegan is Going Mainstream, Trend Data Suggests – foodnavigator-usa.com
• Hellmann’s Vs Just Mayo – Who Knew Mayonnaise Could Be Such a Hot Topic – Natural News