November 2, 2017

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Loosing status “Soy” will no longer be heart healthy.

On Oct 31st, the FDA announced a new proposed ruling, to revoke 21 CFR 101.82 ” Health claims: Soy protein and risk of coronary heart disease (CHD).”


The announcement is carefully worded and long winded, to say the FDA has the right to re-evaluate data, and revoke claims when the data no longer supports the claim.


The FDA certainly has to be careful since soy beans are  a multi-billion dollar industry, and the U.S. is the world’s leading producer [Source: USDA Soybeans and oil crops].


The FDA knows what its up against.  So its no wonder,  they take 20 pages to list in detail their position, and cite 230 bibliographic sources!!!


Its conjecture, but it seems like soy health two health  claims will be gone:


  1. 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.
  2. Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein.


Interested parties have until January 16, 2018 to submit written or electronic comments on the proposed rule.  Massive comments will certainly  delay the process, as the FDA compiles them and systematically responds to them.  But unless their is actual new research that hasn’t yet been published it seems unlikely the outcome will change.




November 2, 2017

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“Local” — “Naturally” the next big fight?

Kelley Drye & Warren LLP, “Ad Law Access” bring us an article “Local” Means Something, but What?


According to BakingBusiness, “A jury in the U.S. District Court for the District of Utah, Central Division, on Oct. 6 awarded Bimbo Bakeries USA $2,105,256 after determining the company suffered damages from trade secret misappropriation and false advertising.”


The lawsuit dates back to August 2013 — US Bakery’s Grandma Emilie’s bread was too similar to Bimbo Bakeries USA’s [BBU] Grandma Sycamore’s bread. US Bakery had acquired the Grandma Emilie’s brand as part of its acquisition of certain assets of Hostess Brands, Inc.” BBU filed suit for trademark infringement, trade secrets misappropriation, false designation of origin, and false advertising.


Although the $2.1M award covers many areas, the suit alleged “the US Bakery’s “Fresh. Local. Quality.” tagline was false in Utah because U.S. Bakery neither maintained a baking facility in Utah nor contracted with a Utah facility to manufacture its products.” [Baking Business]


“The jury attributed over $8 million in profits to the false advertising and awarded over $2 million in total damages (including the trade secret claims). Because the Special Verdict form simply asked for “Yes” or “No” responses, we don’t have any insights into the analysis or a clear answer as to what “local” means.” [Ad Law Access]


In other words, “Local” joins “Natural” and other ill defined words, fully exposed for to private lawsuits.

October 24, 2017

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Stay Alert to Wrigley’s relaunch of Caffeinated Alert Gum

Perhaps you have seen the news:


After 4 years, caffeinated gum relaunches to the public.  Certainly the military dispenses caffeinated gum to its troops, but health risks and concerns are yet to be tested.  Cleary with the FDA on the sidelines and without a formal guidance, Mars Wrigley is taking a calculated risk.


The FDA through policy and regulation, has defined “Energy” as coming from  “carbs, fats, and protein.”  Consumers of central nervous system stimulants like caffeine, experience effects as a boost in  “energy”.


More over caffeinated gum that “confers energy to a human” enters the grey area, and becomes a questionable structure/function claim. This is a particularly interesting situation for FDA enforcement because gum is not a significant source of carbs, fats or proteins.


In all cases, develop your business strategy first, and consider all the risks.  For most companies without the Mars Wrigley resources,  we expect them to choose a  “wait and see what happens strategy.”  Only for the most fearless entrepreneurs with absolutely nothing to loose (i.e. no existing brand, not sales, no reputation) might try and carve out a small niche, and even then you might ask why enter a market that’s decreasing 4% a year. [“U.S. gum sales declined 4% in the first half of 2017, according to IRI data reported by Food Navigator-USA. While Wrigley dominates the category by a wide margin — owning 72% share”]



October 24, 2017

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FDA Releases Convenient Graphic for FSMA Deadlines

The Food and Drug Administration has posted a new webpage that consolidates information on FSMA (Food Safety Modernization Act.)


Most notably they have provided a graphic with key compliance deadlines.  The new FDA webpage does a good job of collecting the definitions in one place, but also highlights the complexity these regulations impose.


Be careful when reading the deadlines!!!  “Small” in one category is not the same “Small” in another category.  Different regulation sections have different definitions!!!

Download the Compliance Dates (PDF: 97KB)



October 23, 2017

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Is a “Healthy” food label claim now just puffery?

Keller and Heckman LLP in their blog, alerted us to a recent Wall Street Journal interview of FDA Commissioner, Dr. Scott Gottlieb. Both the original interview and K&H’s take aways are worth reading, but here’s some key points.

  • A Healthy claim might simply be a commercial claim, and thus not a FDA regulated claim.
    • “We might make a decision that that [healthy] claim is more of a commercial claim and doesn’t really convey something important from a public-health standpoint to a consumer.” (Gottlieb)
    • This begs the question if its not a claim and just a commercial claim, then will “Healthy” simply be a type of puffery. Remember puffery is just a grand claim that the public would never actually consider to be true….such as the phrase “The worlds greatest hamburgers!” So is the phase “The worlds healthiest hamburgers!” just a commercial claims and ok to use? Short answer – consult your attorney.
  • The FDA considers claims (i.e. label and labeling claims) to be a matter of public health.
    • “This [food label regulation] isn’t just an issue of transparency. This is an issue of public health.” (Gottlieb)
    • “You [WSJ Editor, Jacob Bunge]  talk about them as transparency initiatives. I look at them as public-health initiatives.” (Gottlieb)
    • Its worth noting the phrase “public-health” is repeated 9 times, which only emphasizes how much the FDA’s mission, which begins “The Food and Drug Administration is responsible for protecting the public health by…”,  is engrained into their culture,
  • The FDA doesn’t like that states, like California,  end up regulating.
    • ““Healthy”…is a subject of litigation in California.
    • “When certain claims that might be important to providing information to consumers get made in the absence of a scientific framework and get litigated in state courts and torts, outside our review, I think that isn’t what was intended.” (Gottlieb)
  • “Healthy” generates a bunch of industry angst.
    • Keller and Heckman point out, “In September 2016, FDA issued a request for comments on the use of the term “healthy” on food labels, and by April 26, 2017, the Agency received over 1,000 comments.”

Bottom line: The word “healthy” is clearly defined by FDA’s current 21CFR101.55, open to consumer’s interpretation, and subject to litigation on many fronts.


October 4, 2017

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Four Gluten Free Icons

Gluten Free – Three Years after the new standards

The FDA just posted an interview “Taking a Look at the Real-World Impact of the Gluten-Free Labeling Standard

Background: Manufacturers had until August 5, 2014 to properly use and label “gluten free.”  Which means, the product should meet one of the following (see 21 CFR 101.91 Gluten Free Labeling of Food.)

  • inherently gluten free or does not contain an ingredient that is: a gluten-containing grain;
  • derived from a gluten-containing grain that has not been processed to remove gluten;
  • or derived from a gluten-containing grain that has been processed to remove gluten if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.
  • Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

The interview looks at the impact of the gluten-free labeling requirements.  For the full interview see: “Taking a Look at the Real-World Impact of the Gluten-Free Labeling Standard

Here are two of the more interesting questions:

Q: After the rule went into effect, did the FDA do anything to ensure that products with gluten-free labels were in fact gluten-free?

D’Lima: Yes. Earlier this year we released the results of a sampling assignment (FDA Finds 99.5% of foods sampled comply with “gluten free”) in which 702 samples from more than 250 products labeled “gluten-free” were analyzed. Only one of those products did not comply with our labeling requirements. That product was recalled and subsequent sampling did not find any products that violated the regulation. We were very encouraged by these findings.

Q: How much of a difference does it make to have a standard definition of what is called “gluten-free?”

Fasano: It’s been a game changer. At the beginning, many of us were worried about whether the promise of this new standard would truly be realized. But the food industry took this seriously and did an exceptional job with the new labels, aided by the fact that the FDA spelled out exactly what was required.





October 2, 2017

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Snail racing to finish line

Finish line moved, racing forward.

The New Nutrition Facts Final Rules Deadline Extended!!!


Technically the FDA is “proposing to extend the Compliance Dates for the New Nutrition Facts Label Final Rules.”



The new deadline might be Jan. 1, 2020


The FDA posted the announcement in the Federal Register  and as a constituent update on their site at


Specifically the are proposing, “to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until Jan. 1, 2021.”


You now have 30 days, Starting Oct 2nd 2017, to make any comments.  For example, perhaps it should be effective after the New Year’s holiday.

September 15, 2017

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The Scott Gottlieb Ooops Tweet

Dr. Scott Gottlieb, the new FDA head, is creating confusion about the UPDATED Nutrition Facts compliance date.


Food Navigator broke the story and well worth the read.


He spoke at a politico summit and suggested one date…then tweeted a different date.  Once the date is officially published in the Federal Register, then we will have a new target.Scott Gottlieb, The 23rd Commissioner of the U.S. Food and Drug Administration, tweeted an oops.

….this hour’s thinking is that the new date is 18 months out….mid-2019.

This would likely coincide with the required disclosure of genetically engineered ingredient content on foods and supplements.

Knowledge Bank’s next courses for labeling and Nutrition Facts update are next week!


The key takeaway  — “TWEETS” are like “water cooler” gossip.    Tweets and stories must be carefully considered and suspect until proven otherwise.  Tweets are not “legal” announcements of regulations.  The Federal Register remains the only way a regulation can become official.  Even the eCFR (Electronic Code of Federal Regulations) states “It is not an official legal edition of the CFR.”  Only the printed Federal Register remains the official mechanism.

September 12, 2017

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Eat your peanuts!

Moms are always saying to their kids – “eat your veggies.”  Now add “Eat your Peanuts!” to the list.  But read the fine print before you go off and make any new claims.

The FDA now acknowledges that there is sufficient evidence”Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy

As a new qualified health claim you may now start saying:

For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study.

If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.

Clearly this is not a broad blanket statement. But this is a great step forward for the food industry. First, Assured Bites, proves that a company can petition for a qualified claim; and secondly they serve as a real example as to what’s needed to meet the FDA’s rigorous standards.

This also provides the starting point to become  an authorized health claim.

The FDA provides a nice explanation between the “qualified” versus “authorized” health claim:  “The qualified health claim was in response to a petition filed by Assured Bites, Inc. Qualified health claims are not the same as “authorized health claims,” which must be supported by significant scientific agreement among experts in the field. Qualified health claims are supported by credible scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. As such, they are accompanied by qualifying language or a disclaimer so that the level of scientific evidence supporting the claim is accurately communicated.”



September 11, 2017

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The Paradox of Federal Paperwork Reduction – Your Chance to Be Heard!

Few real paradoxes exist. Is it the Chicken or the Egg?


The federal government has no problem with paradoxes. The government passed laws (or rather an executive order), and thus increased the paperwork.  Ironically this executive order aims to reduce paperwork.


Once again the adage, that you have to move backwards to move forward applies. In this case, it is a very good thing.


It’s your chance to be heard. Specifically the FDA and USDA are  formally “seeking seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.”

Here is the FDA and USDA’s list of requests for paperwork reduction:


Some sample questions include:

  • Is the regulation still current, or is it outdated or unnecessary in some way?
  • Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
  • Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority?
  • If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
  • Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
  • Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.</bullet

If you are curious about President Trump’s executive order 13771, “Reducing Regulation and Controlling Regulatory Costs” the full text is here.