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Product Misleading Advertising: Balance of Nature

Review of Balance of Nature: What is it really?
Flat-out Scam or Merely Exaggerated Claims?

Spoiler alert, Our opinion:  It's Overpriced Dried Food Pellets with massively exaggerated health claims!

You may have seen an advertisement for "Balance of Nature" on tv, radio or in a newspaper or magazine? You may have thought that the commercial sounded like a scam and the claims seemed exaggerated and wondered why the government was allowing them to get away with it. In this case, there have been complaints to the FTC about the claims made in the advertising. Below is the text of the FTC's (Federal Trade Commission) warning letter to Balance of Nature's manufacturers.

The Advertisements

Balance of Nature, Inc. represents that its dietary supplement provides the nutrition of over 10 servings of whole fruits and vegetables per day, enhances the immune system, and has numerous other health benefits. They rely almost exclusively on testimonials.

Balance of Nature does not explicitly claim to cure or treat any disease. Instead they use testimonials from people making claims - which are highly subjective and cannot be substantiated - like "Since taking Balance of Nature, I have more energy." Guess what? If you ate a cup of sugar every day, you'd "have more energy", but that does mean that is a good thing to do?

Nonstop absurd claims

The phrase, "I feel like since taking Balance of Nature..."

followed by some absurd claim is heard over and over in their commercials, like:

• "I feel better".
• "I can hit the ball farther".
• "So I started taking Balance of Nature, and I could coach better."
• "With Balance of Nature, I noticed immediately my energy levels picked up"
• "Even with not a lot of sleep, I could function and be the mom I needed to be."
• "It helps you see better."
• "It helps you think better."
• "I've noticed my dreams are better"
• After taking Balance of Nature.. "I can do a kick flip ... and the next day, I wasn't even sore.

 

And they frequently use deceptive attempts to present their (presumably PAID) testimonials are more credible than they are:

• "As an optometric physician" - that's an optometrist, only qualified to fit eyeglasses and detect eye problems; Not a medical doctor. More exaggeration and misleading gobbledygook

 

Really? How could ANY of the benefits in these claims be caused by eating capsules of freeze-dried fruit or vegetables?

Were any of these claims examined objectively? Was any of this measured, independently and objectively? We sure cannot find any such studies conducted by independent researchers at major universities. This is just people who already like the product promoting it. We assume they are paid for their testimonials. If you pay most people enough, they'll go on a commercial and say anything.

It would make as much sense to say "I feel like hitting myself in the head with a hammer makes my joint pain go away" or "Since I started eating fresh, natural dirt from the garden, I have more energy, my bowels are more regular and my dog is better behaved".

In their commercials, they claim they are making it easier to get the vital nutrients fruits and vegetables by freeze-drying the foods and compressing them into a capsule for you to swallow. If you ask us, they are asking you to swallow a lot more than that! Look at their own labels: there are no claims made to nutrients, vitamins, minerals; just calories and total carbohydrates. Hey, nothing is more "fresh and natural" than taking fruit and vegetables, freeze-drying them, grinding them into a powder then compressing them into a capsule for you to eat weeks or months later.

Any child could tell you it's better to eat a fresh apple, banana, orange, etc. And that's not hard to do. Fresh fruit are inexpensive and sold almost everywhere, even in gas stations!

Balance of Nature's "From the Beginning" says Dr. Howard researched

"which fruits and vegetables, when combined, were most effective in 1) Strengthening your Immune System, 2) Cell Protection, and 3) DNA Repair and Apoptosis. Finally in 1997, tireless hours of research culminated in a unique formulation or 31 fruits and vegetables."

OK, Doc Brown reviewed time travel and made a flux capacitor..No one independently reviewed that either. Humor intended for Back to the Future fans; but the point is, Balance of Nature makes "claims"... has anyone else, without a connection to the company reviewed those claims, scientifically and objectively?

Are the Testimonials on the Commercials real?

Only Balance of Nature (or a court inquiry) can tell us that, but does it matter?  There are plenty of self-deluded people who "believe" that wearing tin foil on their heads keeps the government from listening to their thoughts.

Other factors causing the changes reported

Even if we are to believe that these testimonials are truthful, there is NO evidence, ZERO objective, independently reviewed evidence provided, and none we can find, to prove that these claims are true and are not due to something else!  For example, did these people start exercising and losing weight at the same time they started taking Balance of Nature? What other changes occurred in their diet, health or lives during this time? This is why independent studies are done, using a control group and carefully selecting the subjects to limit variables.

We have seen no evidence that this has been done.  Just some very questionable "Russian studies".  See this review.

The Placebo Effect

Anyone who took an intro to psychology course in college is familiar with the placebo effect; simply put,  an improvement of symptoms is observed, despite taking a sugar pill that has no active ingredients at all. due to the person's expectation that it will help. So, even if the people in the commercials are telling us what they believe, it may just be that, their expectation or belief, not objective truth.

FDA Reviews

Dietary supplements, like "Balance of Nature" are not reviewed or approved by the FDA. As a dietary supplement, the manufacturers do not need FDA approval prior to marketing the product. It is the company's responsibility to make sure its products are safe and that any claims are true. There are no government agencies testing or reviewing the product, nor did we find any independent labs or universities (who do not have a connection to the company) conducting any tests or reviews of Balance of Nature, nor validating the claims made in the commercials. The only accountability is if a consumer or other party chooses to take them to court in a lawsuit..

The National Advertising Division (NAD) had its own concerns over Balance of Nature's advertising claims and requested substantiation for the product's health claims, but did not receive any written response. Balance of Nature, Inc. declined to participate in the NAD's self-regulatory process, and so NAD referred the matter to the FTC for review in 2018. The FTC declined to investigate, but NOT because they did not feel the charges were valid, but rather because of "a number of factors related to resource allocation and enforcement priorities," etc. In other words, they had bigger fish to fry and this is just a dietary supplement.

What's in the capsules?

On their commercials, they tell you it is basically freeze-dried fruit and vegetable supplement products. There is a separate bottle for fruits, vegetables, a "Fiber and Spice dietary fiber supplement". The labeling required by law, tells you, in order from most to least, what's in it. The Fruits capsules label says: Aloe Vera, Apple, Banana, Blueberry, Cherry, Cranberry, Grape, Grapefruit, Lemon, Mango, Orange, Papaya, Pineapple, Raspberry, Strawberry, and Tomato.
The Veggies label says: Broccoli, Cabbage, Carrot, Cauliflower, Cayenne Pepper, Celery Stalk, Garlic, Kale, Onion, Shiitake Mushroom, Soy Bean, Spinach, Wheat Grass, Yam, and Zucchini.

Balance of Nature also contains soybeans. Some people avoid soy since it is an estrogenic ingredient that can lead to health issues n some people. Soybeans are high in protein, but obviously there's not enough in a capsule (or even 10 capsules) to be significant on a daily basis)

Who is "Dr. Howard"

The first thing that comes to our mind, is the "Three Stooges" (Moe Howard, Shemp Howard, Curly Howard, Larry Fine). Remember the hospital episode, where they posed as doctors in a hospital? "Paging Dr. Howard! Paging Dr. Fine. Dr. Howard". Humor aside,

Dr. Howard is a chiropractor. 

That's right, a chiropractor.  Not a research epidemiologist, dietitian or even a U.S. medical doctor.

The Balance of Nature Twitter account tells us:

"Dr. Howard earned his Doctor of Chiropractic degree at Cleveland Chiropractic College and had a very successful practice. He was invited to study medicine at Pavlov first Medical Institute in Saint Petersburg, Russia."

and

"Howard became Dean of Foreign Student affairs and finished his medical degree here. Dr. Howard has never practiced in the medical field and has never claimed to."

It is reported on other websites that Dr Douglas Howard (born 1960) earned his Doctor of Chiropractic degree at Cleveland Chiropractic College in 1986. He is reported on other websites and the Dr. Howard Biography website here to have a medical degree from Pavlov first Medical Institute in Saint Petersburg, Russia and studied homeopathy in Germany.

Balance of Nature - the company

Balance of Nature is owned by Dr Douglas Howard, started in 1997. It is a privately owned and operated and based in St George, Utah. The company was started in 1997 by Dr Howard.

Balance of Nature is not accredited by the Better Business Bureau, but there are reviews on their website. Out of 96 reviews there, it had a rating of 3.9 out of 5.

Balance of Nature

PO Box 27740
Las Vegas, NV 89126-7740

Phone: (435) 688-7454.

Organic?

In answer to a question online about whether the product is Organic, Balance of Nature did not answer the question, instead they said:

At Balance of Nature we do everything it takes to produce the very best product. No shortcuts. We go beyond the "USDA Organic" seal. Our products contain produce grown, handled, processed, and certified in a way that meets and exceeds the requirements for using the USDA Organic seal.

Hmm, exactly  HOW does a product go "beyond the USDA Organic seal"?  They don't say. That implies the product is NOT certified organic under the federal NOP program. Only foods and products that are certified organic under this program are allowed to label or market their products as organic in the United States.. Notice that the word organic does not appear anywhere on the label.

The Bottom Line

We rate this product a nonsensical waste of money, based on:

1. GROSSLY exaggerated CLAIMS - The testimonial claims are subjective, exaggerated and not verifiable
2. Expensive, grossly over-priced for freeze-dried vegetables and fruit
3. Fresh fruit and vegetables are better
4. The FDA sent them a letter demanding they cease making medical claims;
5. The Better Business Bureau has numerous complaints from customers (see below)

For all we can tell, Dr. Howard is a nice guy and intelligent. But so was Moe Howard. Dr. Howard's advice in his video is excellent, talking about taking accountability for your own health, fitness, emotional and spiritual health. That's good advice. But paying about $100 for a 30 day supply of freeze-dried food pills is simply insane. You are wasting your money and buying positively absurd hype.

Go buy a bag of apples, some bananas, peaches or eat a salad instead. You don't have to be a food scientist to know that unprocessed, fresh foods are always better for you than a manufactured freeze-dried pill. Eating these pills probably won't do you any harm, but their present prices, they sure will harm your wallet!

If you live in a desert and have loads of money (hmm, another Howard, Howard Hughes comes to mind), okay, buy the dried food pills..

And if you REALLY want to buy them, we won't stop you. In fact, You can click here and buy them and we will earn a small commission from the sale, so go right ahead and buy Balance of Nature!

We do not rate this product as an out-and-out scam; just over-hyped, overpriced dried food pills. Like those little green tablets we used to feed our pet rabbits and guinea pigs as children.  And in our opinion, the testimonial claims are grossly exaggerated nonsense.

Other complaints, reviews and reports

1. The Better Business Bureau gives the Balance of Nature company a D rating (Sept 2021) upgraded to a "B" rating October 2022, but you should REALLY read the complaints. It says on the BBB website "THIS BUSINESS IS NOT BBB ACCREDITED" and adds the footnote: "This rating reflects BBB's opinion about the entire organization's interactions with its customers, including interactions with local locations."
   The BBB customer reviews gave them 1.5 stars out of 5.
2. "Supplements maker Balance of Nature making false coronavirus claims, watchdog says"
   By Lisa Fickenscher, April 15, 2020, NY Post
   Excerpt:
   "Supplements maker Balance of Nature is making phony claims that its products can ward off the coronavirus, a consumer watchdog claimed in federal complaints filed Tuesday.
   The Utah-based company - which touts its "Fruits and Veggies" supplements on radio programs hosted by comedian Joe Piscopo and political commentator Kevin McCullough among others - falsely claims that they can "prevent and help treat the coronavirus by boosting a person's immune system," according to the complaints filed with the Federal Trade Commission and to the Food and Drug Administration."
3. Illuminate Labs - A medical doctor's review - Excerpt below:
   ' "the page on their website titled "Our Process" makes very strange claims about the benefits of powdered food: " The scientific blend, or recipe, developed by Dr. Howard does not use a full serving of each fruit and vegetable. Through trial and error, research, and experimentation, a precise and balanced combination was discovered. This balance is what gives us the wonderful results we enjoy today."
   
   The above quote seems to suggest that the proprietary formula is more effective than the equivalent doses of whole foods, but that claim is not cited nor does it make any logical sense.
   The third claim on this page is even stranger: " With some of the fruits and vegetables you eat, as little as 5 percent of the available nutrition will be absorbed because it has not been properly masticated, or chewed. For example, when we eat an apple we chew it; but it'
   s still swallowed in chunks. To some degree this inhibits the absorption of the nutrients within the apple.
   This set of "clinical research" is some of the strangest that we've reviewed, and we fail to understand how a study on lactation in rats has anything to do with human general health maintenance, or why Balance of Nature shares this information"
   '
   

FTC Warning letter to Balance of Nature

August 20, 2019

WARNING LETTER

Ref: # HAF4W (DEN)-19-09-WL

Dear Mr. Howard:

On February 4 - 8, 2019, the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 785 E. Venture Dr., St. George, UT. During the inspection, our investigator collected product labels and written material accompanying your products. In addition, we reviewed labeling on your firm's website at www.balanceofnature.com and your YouTube channel at www.youtube.com/user/balanceofnature1. The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and its implementing regulations through links on FDA's home page at www.fda.gov.

We acknowledge receipt of your response to the FDA-483, Inspectional Observations, dated February 18, 2019, and we address your response below.

Unapproved New Drugs/ Misbranded Drugs

FDA reviewed your website at the Internet address www.balanceofnature.com and your YouTube channel at www.youtube.com/user/balanceofnature1 in July 2019 and has determined that you take orders on your website for your Whole Food Fruits, Whole Food Veggies, and Whole Food Fiber & Spice products. Your website links to your YouTube channel and your YouTube channel links back to your website. In addition, we reviewed the product labels and written material accompanying your shipments collected during the inspection. The claims on your product labeling, including your website and YouTube channel, establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. - 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the labeling claims that provide evidence that your products are intended for use as drugs include:

Whole Food Veggies capsules:

• Product pamphlet titled "Quick Tips for Quick Relief" that accompanies the product in shipping boxes: "Do you have an itchy, sore, or scratchy throat? Sprinkle the contents of 3-6 Veggies capsules into a cup of warm broth, stir together and drink. Also, keep a few extra fruit capsules in your pocket to chew on when you feel symptoms coming on . . . . These two tricks will . . . soothe your throat and ease coughing . . . When flu, cold, or allergy seasons come around double up at the beginning and throughout the season . . . You'll be amazed at how fast you'll kick it!"

Whole Food Fiber & Spice:

Statements on the product label:

• "Diabetics: Proven safe and effective for diabetics. Studies demonstrate that polyphenol compounds found in Fiber & Spice improve insulin sensitivity leading to improved insulin function."
• "Arthritis: Many of the phytochemicals found in Fiber & Spice have been shown to possess anti-inflammatory properties."
• "Lower cholesterol: Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in Fiber & Spice, may reduce the risk of heart disease by lowering cholesterol."

Whole Food Fruits, Whole Food Veggies, and Whole Food Fiber & Spice:

• From the webpage "Whole Health System" on your website www.balanceofnature.com: "By taking these supplements consistently, you'll begin to feel the positive effects of . . . Fiber consumption and its cholesterol reducing properties"
• From the video posted to your YouTube channel, How to Help Overcome Relapsing MS:
  • The name of the video constitutes a claim that your products are intended for use in the cure, mitigation, treatment, or prevention of Multiple Sclerosis (MS).
  • From the video description: "Marie explains her daughter's situation with MS and how Balance of Nature's Fruits and Veggies have helped her with the energy and strength to fight her condition. Please share this with people you know fighting this same condition. . . Balance of Nature will give you over 10 servings of fruits and vegetables every day. 'The American Institute for Cancer Research' and the 'USDA' have confirmed that eating 9 to 11 servings of fruits and vegetables every day is the key to preventing cancer and other lifestyle diseases."
• From Real Balance of Nature Customer with MS video page posted to YouTube channel:
  • The name of the video constitutes a claim that your products are intended for use in the cure, mitigation, treatment, or prevention of Multiple Sclerosis.
• From No More Inhalers for Her Asthma video posted to YouTube channel:
  • The name of the video constitutes a claim that your products are intended for use in the cure, mitigation, treatment, or prevention of asthma.
  • From the video description: "Balance of Nature has helped Janna with her allergies. She no longer needs her Asthma inhaler . . . . [S]he has also seen improvements in her skin as she visited her dermatologist for quarterly skin cancer checkups."
• From How to Stay Healthy & Physically Active at 80 Years Old video posted to YouTube channel:
  • From the video description: "Now, with the 'wheelbarrow fulls' of real food that she gets with Balance of Nature, she hasn't had pneumonia in 5 years."

Your YouTube channel also contains additional evidence of intended use in the form of personal testimonials recommending or describing the use of the products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

• From the video posted to your YouTube channel, How to Eat Natural Healthy Whole Food with a Busy Lifestyle - Prostate PSA Success Story:
  • (4:15) "Aside from cancer I know Balance of Nature helps with the smaller illnesses the kind of the day-to-day illnesses. For myself in two years that I've been on it I don't even think I've had a cold not never mind the flu not even nothing close to the flu."
• From Real Balance of Nature Customer with MS video page posted to YouTube channel:
  • (1:42) "after maybe three years I think that was look [sic] was that the first time I had an MRI without any new active lesions being on balance of nature"
• From How to Stay Healthy & Physically Active at 80 Years Old video posted to YouTube channel:
  • (1:10) "I've had some health issues...I've had pneumonia I can't even tell you how many times... I did not even have a bad cold this whole last winter and I think that's due to my being very diligent in taking my Balance of Nature..."
• From No More Inhalers for Her Asthma video posted to YouTube channel:
  • (2:06) "One of the best things about these [Balance of Nature products] is people with asthma, they say it goes away."
  • (2:29) "Went from all this asthma medication to none . . . no more asthma symptoms."
  • (2:41) "The second benefit [of Balance of Nature], I had skin cancer when I was 21, a melanoma . . . every three months I would go into the dermatologist and, you know, get moles removed . . . within a year after taking this [Balance of Nature products] my dermatologist [said] . . . well, you're fine, you don't need to come back every 3 months"

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. - 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. -- 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. - 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. - 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Whole Food Fruits, Whole Food Veggies, and Whole Food Fiber & Spice are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Whole Food Fruits, Whole Food Veggies, and Whole Food Fiber & Spice products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. - 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. - 331(a)].

Adulterated Dietary Supplements

Even if the labeling of your Whole Food Fiber & Spice, Whole Food Veggies, and Whole Food Fruits products did not have therapeutic claims that make them unapproved new drugs, the products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. - 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111), as follows:

1. You failed to implement a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, you have not established and implemented a system of production and process controls.

As a distributor that contracts with other manufacturers to manufacture, package, and label dietary supplements for distribution under your firm's name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery of, the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.

During the inspection, management stated that your firm distributes proprietary dietary supplement products under your brand names and that these dietary supplement products are manufactured for your firm by a contract manufacturer. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. [See United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has "a responsible share in the furtherance of the transaction which the statute outlaws"); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that "agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act" can be held accountable for violations of the Act)]. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)).

Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).

2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Specifically, you do not have written procedures for responsibilities of the quality control operations and you do not document any of the required quality control operations for the processes you perform, such as approval of contract manufacturers, approval of raw material suppliers, approval of formulations, and approval of labels.

We have reviewed your letter, dated February 18, 2018, which states that you are currently working on developing written quality control procedures. We are unable to evaluate the adequacy of your response because you did not provide any documentation of the quality control procedures.

3. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. Specifically, you do not have any written procedures for product complaints.

We have reviewed your letter dated February 18, 2019, which states that you are currently working on procedures for how each complaint is reviewed and investigated. We are unable to evaluate the adequacy of your response because you did not provide any documentation of the product complaint procedures.

Once you have established the procedures required by 21 CFR 111.553 and 21 CFR 111.560, you must maintain written records of every complaint related to good manufacturing practice and records of the findings of any investigation and follow-up action when an investigation is performed, as required by 21 CFR 111.570(b)(2).

Misbranded Dietary Supplements

Even if your Whole Food Fruits, Whole Food Veggies, and Whole Food Fiber & Spice products were not unapproved new drugs, they would still be misbranded foods within the meaning of section 403 of the Act [21 U.S.C. - 343]. Specifically, our review of your product labels revealed that your products are misbranded within the meaning of section 403 of the Act as follows:

1. Your Whole Food Fiber & Spice product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. - 343(a)(1)] in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. - 321(n))]. Specifically, the product contains dry or incompletely hydrated psyllium husk, and the product label bears the following health claim on the association between soluble fiber from psyllium husk and reduced risk of coronary heart disease: "Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in Fiber & Spice, may reduce the risk of heart disease." Under 21 CFR 101.17(f), foods containing dry or incompletely hydrated psyllium husk that bear a health claim on the association between soluble fiber and reduced risk of coronary heart disease, see 21 CFR 101.81, must bear a label statement informing consumers that the appropriate use of such foods requires consumption with adequate amounts of fluids, alerting them of potential consequences of failing to follow usage recommendations, and informing persons with swallowing difficulties to avoid consumption of the product. However, the label of your Whole Food Fiber & Spice bears no such required warning statement.
2. Your Whole Food Fiber & Spice powder, Whole Food Fruits capsules, and Whole Food Veggies capsules products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. - 343(q)(5)(F)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.9 and 21 CFR 101.36. For example:
   1. Your Whole Food Fiber & Spice product label fails to round the values for the (b)(2) ingredients in accordance with 21 CFR 101.9(c)(6). The label bears an incorrect %DV for total carbohydrate based on the quantitative amount declared per serving.
   2. Based on the declaration of total carbohydrate and total omega fatty acids on the Whole Food Fiber & Spice product label, the label is not in compliance with 21 CFR 101.36(b)(2): the (b)(2)-dietary ingredients to be declared, that is, total calories, calories from fat, and total fat, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 101.9(c). However, total calories, calories from fat, and total fat are not declared on the product label.
   3. Your Whole Food Fiber & Spice product label declares dietary fiber in an amount that is greater than the quantitative amount declared for total carbohydrate. Total carbohydrate must be greater than or equal to the sum of carbohydrate components including dietary fiber and total sugar.
   4. Your Whole Food Fiber & Spice product label's other 21 CFR 101.36(b)(3) dietary ingredients must bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement, "Daily Value not established." 21 CFR 101.36(b)(3)(iv).
   5. Your Whole Food Fruits capsules and Whole Food Veggies capsules product labels do not list the dietary ingredients in the proprietary blend in descending order of predominance by weight as required by 21 CFR 101.36(c)(2); and the quantitative amount of the proprietary blend is not placed on the same line to the right of the term "Proprietary Blend" as required by 21 CFR 101.36(c)(3).
   6. Your Whole Food Fiber & Spice product label presents the "Ingredients list" within the Supplement Facts label. The label must present the ingredient statement outside and immediately below the Supplement Facts box and the ingredients must be listed in descending order of predominance by weight in accordance with 21 CFR 101.4(a) and 21 CFR 101.4(g). Furthermore, the Supplement Facts box includes terms that are not permitted, such as "Ingredients," "no added sugars" and "no artificial sweetener," 21 CFR 101.9(c).
   7. Your Whole Food Fruits capsules and Whole Food Veggies capsules product labels bear a symbol (that is, an asterisk) which refers to the same symbol placed at the bottom of the nutrition label that is followed by the statement "Daily Value not established" in accordance with 21 CFR 101.36(c)(3), but the symbol is placed immediately after the term "Proprietary Blend." The symbol must be placed immediately following the quantitative amount by weight for the proprietary blend.
   8. Your Whole Food Fruits capsules, Whole Food Veggies capsules, and Whole Food Fiber & Spice powder products' formatting of the Supplement Facts label is not in accordance with 21 CFR 101.36(e), specifically with respect to the use of heavy bar, light bars, and hairline rules and/or the "Supplement Facts" type size.
3. Your Whole Food Fruits capsules and Whole Food Veggies capsules products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. - 343(r)(1)(A)] because the product labeling bears nutrient content claims but fails to comply with the requirements for making such claims. Specifically, the labels of the Whole Food Fruits capsules and Whole Food Veggies capsules products bear the claim, "More antioxidant power than any other brand."

Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to the nutrient content claim for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.

Nutrient content claims using the term "antioxidant" must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim, as required by 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, as required by 21 CFR 101.54(g)(2). Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity, as required by 21 CFR 101.54(g)(4). The above quoted antioxidant claim on your product labels is a nutrient content claim because it characterizes the level of antioxidants in your products, but they do not comply with 21 CFR 101.54(g)(4) because the label does not include the names of the nutrients that are the subject of the claim.

Additionally, the claim "More antioxidant power than any other brand" is a "relative claim." The claim fails to include the accompanying information for relative claims as required by 21 CFR 101.13(j). In order to bear a relative claim about the level of a nutrient, the amount of that nutrient in the food must be compared to an amount of nutrient in an appropriate reference food as specified under 21 CFR 101.13(j)(1) and the label or labeling must state the identity of the reference food under 21 CFR 101.13(j)(2).

4. Your products Whole Food Fruits capsules and Whole Food Veggies capsules are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. - 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the products are encapsulated but the labels fail to list the capsule ingredients.

Additionally, your Whole Food Veggies capsules product declares "yam" as part of the proprietary blend whereas the product's batch record for lot #20191401 (from (b)(4) inspection ending 2/8/2019) lists "wild yam." These are two different botanical ingredients - the label must state the common or usual name for the dietary ingredient used in the product.

5. Your Whole Food Fruits capsules, Whole Food Veggies capsules, and Whole Food Fiber & Spice powder products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. - 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, stalk, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
6. Your products Whole Food Fruits capsules, Whole Food Veggies capsules, and Whole Food Fiber & Spice powder products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. - 343 (e)(1)] in that their labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The street address may be omitted if it is shown in a current city directory or telephone directory.
7. Your Whole Food Fruits capsules and Whole Food Veggies capsules products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. - 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct all the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation, such as photographs, corrective actions taken to date, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.

Further, Section 743 of the Act, 21 U.S.C. - 379j-31, authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the inspection fees, 21 U.S.C. - 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; 6^th Ave. and Kipling St., P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.

Sincerely,

/S/
LaTonya M. Mitchell, PhD.
Denver District Director
Program Division Director
Office of Human and Animal Food Operations -
Division IV West

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