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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Heartland Products, Inc. 22-Oct-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612)758-7114
FAX: (612) 334-4142


October 22, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 08 - 03

Richard J. Dietrich
President
Heartland Products, Inc.
849 14th Street SW
Valley City, North Dakota 58072

Dear Mr. Dietrich:

This letter is in reference to your firm's manufacturing, distribution and promotion of various products documented by our inspection conducted on February 1-2, 2007, of your facility located at Valley City, North Dakota, and a review of your internet web sites on September 13, 2007, www.heartlandnatural.com, www.flaxnaturally.com, www.uberbalance.com, and www.licearrest.com. These activities were conducted to determine your firm's compliance with the Federal Food, Drug and Cosmetic Act (the Act) and applicable implementing regulations contained within Title 21 of the Code of Federal Regulations (21 CFR) Part 101. You can find the Act and implementing regulations through links on the FDA's Internet and home page at www.fda.gov.

Our review of your product labeling, promotional materials and your internet web sites shows serious violations of the Art in the label and labeling of these products.

Drugs

Under the Act, articles intended for use in the, diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs.[section 201(g)(1)(B) of the Act, 21 USC § 321(g)(1)(B)].

Examples of claims in your product labeling, including your web site, that promote your products as drugs are as follows:

Flax naturally TM Concentrated Lignans (powder, 5.3 ounce and 90 capsule packages):

www.heartlandnatural.com

• "Studies indicate these Lignans have tremendous health benefits that include anti-viral, anti-bacterial, anti-fungal, and anti-cancer properties."
• "Lignans can help support: . . .Anti-fungal functions, Anti-viral functions, Anti-parasitical functions, Anti-carcinogenic functions (Lignans have been shown to have anticancer properties. Breast and prostate cancers are the most affected by lignan activity)."

Furthermore, your web site also contains references to selected publications that are implied disease claims for the product Flax Naturally Concentrated Lignans in the context they are used (21 CFR 101.93(g).(2)(iv)(C)]. Examples include:

• "Reactive oxygen species (ROS), have been implicated in the development of diabetes mellitus. SDG isolated from flaxseed is an antioxidant. An investigation was made of the effects of SDG on the development of diabetes in rates, to determine if SDG can prevent/reduce the development of diabetes and if this prevention/reduction is associated with reduction in oxidative stress. RESULTS: SDG prevented the development of diabetes by75%." (Prasad K, et al, Mol Cell Biochem 206(1-2):2000; Prasad, K. Mol Cell Biochem, 209(1-2) 89: 2000).

• "Flaxseed SDG may have a therapeutic effect in lupus nephritis." (Clark, W.et al. Lupus 9(6): 429, 2000).

• "Dietary estrogens, such as lignan-rich flaxseed, are similar in structure to endogenous sex steroid hormones and act in vivo to alter hormone metabolism and reduce subsequent cancer risk in postmenopausal women." (Hutchins A, Cancer Epidemiol Biomarkers Prev, 9(10): 1113, 2000).

• "Research suggests that SDG reduces hypercholesterolemia atherosclerosis and that this effect is associated with a decrease in serum cholesterol, LDL-C...." (Prasad K. Circulation, 99(10): 1355, 1999).

• "Flaxseed is high in secoisolariciresinol diglycoside (SDG), the precursor of mammalian lignans, which can affect mammary gland structure. Lifetime or gestation and lactation exposure to 5 or 10% flaxseed induce structural changes in the mammary gland that may potentially reduce mammary cancer risk." (Tou J & Thompson L. Carcinogenesis, 20(9): 1831, 1999).

• "Because flaxseed and its lignans are colon cancer protective, it is concluded that, in contrast to other studies, beta-glucuronidase activity may play a beneficial role in their presence by increasing mammalian an lignan absorption and enterohepatic." (Jenab M, et al. Nutr Cancer, 33(2): 154, 1999).

• Dietary supplementation with secoisolariciresinol diglycoside (SDG), a lignan precursor isolated from flaxseed, significantly reduced pulmonary metastasis cells and inhibited the growth of metastatic tumors that formed in the lungs. (Li D. et al, Cancer Lett, 14 2(1): 91, 1999).

• "Flaxseed the richest source of lignans reduces metastasis and inhibits the growth of the metastatic secondary tumors in animals. Flaxseed may be a useful nutritional adjuvant to prevent melanoma metastasis in cancer patients." (Yan L, et al, Cancer Lett, 124(2):181, 1998).

Flax Naturally brochure

(Under "Health Benefits of Flak" section)

• "Lignans have been shown to have anticancer, antibacterial, antifungal and antiviral properties. Breast and prostate cancers are the most affected by lignan activity."

•"Omega-3 fats are important in modifying the body's inflammatory response, making them very helpful to people with inflammatory diseases."

• "It has been shown to be of benefit to people with attention deficit disorder, depression, and bipolar disorder in adults and children."

• "Soluble fiber has shown to lower cholesterol and regulate blood sugars, thereby helping both heart disease and diabetes. Those with in-somnia may find that flax seed may help stabilize blood sugars for a more restful sleep."

• "Insoluble fiber...plays an important role in the prevention of colon cancer."

(Under Flax 'Seed Lignans section )

• "[L]igans have tremendous health benefits which help boost the immune system to fight off viruses, bacteria and fungus."

•"Lignans can help support: . . .Anti-fungal functions, Anti-viral functions, Anti-parasitical functions, Anti-carcinogenic functions (Lignans have been shown to have anticancer properties. Breast and prostate cancers are the most affected by lignan activity)."

Aqua MinTM Concentrate:

www.heartlandnatural.com

(Under the heading "Aqua Min Concentrate")

• "Silver has been used for thousands of years as a natural antibiotic remedy. . . [I]t served as a powerful aid in fighting disease and preventing infections."

• "Use Aqua Min as a dietary supplement. . . . Using daily can help your body fight away bad bacteria. . ."

Agua Min brochure

• "Aqua Min used as a dietary supplement. . .may help your body fight off harmful bacteria.. . ."

• "Silver has been used for thousands of years as a natural antibiotic remedy. . . [I]t served as a powerful aid in fighting disease and preventing infections."

•"Silver is reputed to be effective against over 650 types of bacteria, viruses and diseases."

Coconut Oil and Coconut Cream ConcentrateTM:

www.heartlandnatural.com

(Under the heading "Why Choose Coconut Oil?")

• "Reduce the risks of cancer and heart disease"
• "Help prevent bacterial, fungal, and viral infections"
• "Stabilize blood pressure"


Uber Greens™:

www. heartlandnatural. com.

• "Aids in Balancing Blood Sugar"
• "Uber GreensTM contain . .. flax lignans. Studies indicate these lignans have tremendous health benefits. . .to fight off viruses, bacteria and fungus."
• "[Apple Pectin] has. . .been shown to increase the body's ability to rid itself of cholesterol. . . and reduce serum cholesterol levels."
• "[Lecithin] has. . . been shown to reduce the absorption of dietary cholesterol and block it from re-absorption into the blood stream."
• "Licorice. . .has been shown to be greatly useful in the treatment of ulcers and as an expectorant/cough suppressant. This herb is also postulated to possess hypolipidemic (cholesterol . . . lowering), anticariogenic (antiplaque and anti-tooth decay), antimicrobial and antiviral, immunosuppressive, antianemia, and antihepatotoxic properties."
• L. Acidophilus is widely used. . . . Many studies have confirmed its beneficial effects for. . . inhibiting growth of harmful bacteria. . . and increasing the bodies [sic] natural resistance to infection."
•"Enzymes help our body break-down undigested food. This undigested food causes a problem because it manifests itself as high cholesterol... arthritis.... "

Uber Greens™ brochure

• "Aids in Balancing Blood Sugar"
•"Uber GreensTM contain... flax lignans. Studies indicate these lignans have tremendous health benefits...to fight off viruses, bacteria and fungus."

Topical Drugs

Uber Balance Progesterone:

The ingredient statement for Ober Balance reads, in part: "...Ingredients: Purified Water. . . Natural Progesterone (USP), Aloe Vera, . . .Saw palmetto, Cramp Bark. . . Lemon Grass Oil. . ."

Examples of disease prevention and treatment claims for Uber Balance Progesterone found on your web site www.heartlandnaturals.com include:

• "When do I use Natural Progesterone Cream?. . .Premenopause...Irregular Periods. . . . Hysterectomies, Menopause, or Post menopause or Osteoporosis.... "

• "Natural hormones in a cream base can be used intra vaginally and has [sic] been very successful in treating vaginal dryness and vulvar atrophy . . . ."

• "Are there any other benefits of Natural Progesterone use? Additional benefits for women include: . . .improvement of skin problems including acne, seborrhea, rosacea, psoriasis and keratoses. . ."

• "Progesterone Effects: . ..Protects against fibrocystic breasts. . . Natural diuretic. . . Natural antidepressant. . . Facilitates thyroid hormone... Normalizes blood clotting. . . Norrualizes blood sugar levels. . . Prevents endometrial cancer. . .Helps prevent breast cancer. . . . "

(Under the heading "Ingredients: . . . Ober Balance Progesterone Cream")
•"Aloe Vera. . .healing, and anti-inflammatory properties . . . Saw Palmetto Berries. . .reduce inflammation and prostatic enlargement for men . . . . .Lemon Grass Oil- is an astringent . . ."

Examples of disease prevention and treatment claims for Ober Balance Progesterone found in your promotional brochure include:

•"Are there any other benefits of natural progesterone use? Additional benefits for women may include: . . .diminished muscular aches and pains. . improvement of skin problems including acne, seborrhea, rosacea, psoriasis and keratoses... ."

•"When do I use natural progesterone cream? . . .Premenopause. . .Irregular Periods. . . . Hysterectomies, Menopause, or Post menopause or Osteoperosis. . ." "[P]rogesterone may eliminate fibrocystic breasts . . . . "

•"Natural hormones in a cream base can be used intra vaginally and has [sic] been very successful in treating vaginal dryness and vulvar atrophy . . . ."

NaturGesic™ Cream:

The ingredient statement for NaturGesicTM reads, in part: "Menthol, Aloe Vera, Carbomer, Decyl Polyglucose, Emu Oil, Glycerine, Grape Fruit Seed Extract, Orange Peel Extract, Witch Hazel, Yucca Extract... ."

Examples of disease prevention and treatment claims for NaturGesicTM Cream found on your web site www.heartlandnaturals.com, include:

• "NaturGesic™
• . . .Relieves Pain! Relieves Muscle Soreness! Reduces Inflammation!"

(Under the heading "NaturGesic")

• "NaturGesic is an all-natural analgesic blend of plant extracts. . . ."
• "MENTHOL. . . .is also a mild local anesthetic."
• "ALOE VERA. . . .is used to treat burns and mild abrasions. . . ."
• "GRAPEFRUIT SEED EXTRACT - An organic anti-microbial and fungicidal agent. . ."
• "ORANGE PEEL EXTRACT. . . .works as an anti-inflammatory agent."
• "YUCCA EXTRACT. . . .Used to treat burns and mild abrasions, works as an anti-inflammatory and reduces erythema. . . ."
• "Suggested Uses: • Arthritic Pain • Bruises. . . ."
• "NaturGesic. . .relieves pain and muscle soreness and reduces inflammation."
• "Emu Oil does have the ability to reduce inflammation of the joints."

Joint and Pain Cream:

The ingredient statement for Heartland Naturals™ Joint & Pain Cream reads: "Arnica 1X, Gluosamine Sulfate in liposome base, Emu Oil."

Examples of disease prevention and treatment claims for Heartland Joint & Pain Cream found on your web site www.heartlandnaturals.com, include:

• "...Natural Anti-Inflammatories
Arnica is known for its analgesic, antiseptic and anti-inflammatory properties. Arnica is widely used as a topical treatment to help...arthritis pain."

Examples of disease prevention and treatment claims for Heartland Joint & Pain Cream found on your promotional brochure include:

• "Heartland Natural™ Joint & Pain Cream may be used to help relieve pain and inflammation caused by arthritis. . . ."

• "Arnica is known for its analgesic, antiseptic and anti-inflammatory properties. Arnica is widely used as a topical treatment to help. . . arthritis pain."

An example of a disease prevention and treatment claim for Heartland Joint & Pain Cream found on the immediate product label includes:

• "Relieves Pain & Inflammation Caused By: Arthritis"

Lice Arrest™:

The composition of Lice Arrest™ reads, in part, "botanic soap composed of a proprietary blend of a natural plant based alcohol, purified water and saponified fatty acids derived from plant sources. There are no animal ingredients or derivatives nor medicinal ingredients in Lice Arrest. . ."

Examples of disease-prevention and treatment claims for Lice Arrest™ found on your web site www.heartlandnaturals.com include:

• ". .harmlessly remove these pests with out the risks associated with pediculicides (poisonous pesticides). . . ."
• ". . .is quick acting in washing away head lice and their nits..."
•"To help prevent re-infestation, dilute 1 (one), part Lice Arrest™ with 1(one) part water, put in spray bottle. Use 3-4 sprays to wash hair daily for 2-4 weeks."

•"Lice must be killed in order to stop infestation. . . . The most popular method used is poisoning by the use of extremely toxic pesticide and insecticide chemicals. . . . Is there a better way to deal with lice? Yes, find a safe botanical soap such as Lice Arrest™. Since soap does not use poisoning as a method of killing the lice, the lice cannot grow immune, nor is there any chance of also poisoning the humans using the product."

These claims cause your products to be drugs as defined in section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act [21 U.S.C. §321(p)]. Under section 505 of the Act (21 U.S.C. § 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new Drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Further, these products are misbranded within the meaning of section 502(f)(1) [21 U.S.C. § 352(f)(1)] of the Act in that the labeling for these drugs fails to bear adequate directions for use.

OTC topical hormone-containing products labeled or promoted for use as drugs are subject to the final rule under 21 CFR § 310.530(b). This rule states that any OTC drug product, other than hydrocortisone, that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use, as noted above, is regarded as a new drug. Your Ober Balance Progesterone product falls within this rule because its labeling promotes it as a topical hormone product for drug use. In order to be legally marketed in the United States, all new drugs must be the subject of approved applications, 21 U.S.C. § 355(a). Since Ober Balance Progesterone is not the subject of an approved new drug application, its marketing in the United States violates section 505(a) of the Act, 21 U.S.C. § 355(a).

Drug products intended for indications such as those promoted for NaturGesic Cream and Joint and Pain Cream are being evaluated under the developing monograph for OTC External Analgesics within the overall OTC Drug Review. The Tentative Final Monograph (TFM), published in the Federal Register on February 8, 1983 (48 Fed. Reg. 5852), did not include the particular combination of ingredients used in your products. Additionally, the indications for use for the NaturGesic Cream and Joint and Pain Cream, such as reduces inflammation, are not included in the developing monograph for OTC external analgesics. Furthermore, we are unaware of products with these indications for use having been marketed OTC in the United States at the inception of the OTC Drug Review. Therefore, these products are not deferred to that Review. Additionally, they have not been recognized by qualified scientific experts as safe and effective for their labeled external analgesic uses. Accordingly, your NaturGesic Cream and Joint and Pain Cream products are new drugs as defined by section 201(p) of the Act, 21 U.S.C. 321(p). Since your NaturGesic Cream and Joint and Pain Cream products are not the subjects of approved new drug applications, their marketing in the United States violates section 505(a) of the Act, 21 U.S.C. § 355{a).

The labeling for NaturGesic Cream also promotes one of its components as a "fungicidal agent." Therefore, NaturGesic Cream is also subject to the OTC Final Rule for Topical Antifungal Drug Products at 21 CFR Part 333, Subpart C. None of the labeled ingredients for NaturGesic Cream are included as active ingredients for any use in the Antifungal products Final Rule {see 21 CFR 333.210). NaturGesic Cream is not generally recognized as safe and effective as a fungicidal agent, causing it to be a "new drug" as defined in section 201(p) of the Act, 21 U.S.C. § 321(p). Because your NaturGesic Cream product is not the subject of an approved new drug application, its marketing in the United States violates section 505(a) of the Act, 21 U.S.C. § 355(a).

Further, the claims for Lice Arrest establish that the product is intended for use in the cure, mitigation, treatment; or prevention of pediculosis in man. Accordingly, Lice Arrest is a drug under section-201(g) of the Act, 21 U.S.C. § 321(g). OTC human pediculicide products are subject to a final regulation at 21 CFR Part 358, Subpart G. Under those regulations, the only acceptable ingredients for OTC pediculicide drug products are pyrethrum extract and piperonyl butoxide. The Lice Arrest product does not comply with this final rule. Additionally, because there is no evidence that Lice Arrest is generally recognized as safe and effective for these claims indications, Lice Arrest is a new drug as defined by section 201(p) of the Act, 21 U.S.C. § 321(p). Therefore, your Lice Arrest product is an unapproved new drug that may not be legally marketed since it does not have an approved application, under section 505 of the Act, 21 U.S.C. § 355.

Misbranded Foods

Your Flax naturally™ Concentrated Lignans Powder, Flax naturally™ Capsules, and Flax naturally™ Real Cold~Milled Flax Seed products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] for bearing unauthorized nutrient content claims. For example, your products bear the claims "High in SDG Lignans" and "High Lignan Content." However, authorized nutrient content claims are limited to substances that have a Reference Daily Intake (RDI) or Daily Reference Value (DRV), and there are no RDI or DRV for Lignans. In addition, your Flax Seed product bears the claim "Excellent Source of Omega 3." However, omega-3 nutrient content claims may only be made in the labeling of conventional foods and dietary supplements based on authoritative statements (See Dockets 2004N-0217, 2005P-0189, and 2006P-0137) as provided for in section 403(r)(2)(G) of the Act. Each of the omega-3 fatty acid nutrient content claims authorized under 403(r)(2)(G) of the Act require the claims to identify the specific omega-3 fatty acid, and the amount of omega-3 fatty acid in the food. The omega-3 claim on this product does not meet these requirements. In addition, your product Flax naturallyTM Concentrated Lignans Powder bears the claim "Excellent Source of Dietary Fiber," however, your product does not declare the amount and "percent daily value (DV)" of fiber in the nutrition labeling to determine if you meet the requirement to make this claim. The nutrient content claims for "excellent source or and "high in" may be used if the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed 121 CFR 101.54(b)].

Your Flax naturally™ Real Cold-Milled Flax Seed is misbranded within the meaning of section 403(r)(1)(B) for making an implied health claim. Specifically, your product bears the claim "Heart Healthy." "Heart Healthy" is a health claim implying a relationship of flaxseed or a component of flaxseed to heart disease risk. However, there is no authorized health claim or qualified health claim characterizing a relationship of flax seed and heart disease.

Your Ober Green Dietary Supplement product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)]. For-example, you declare the ingredient "Concentrate™ Ionic Trace Minerals (Proprietary. Blend)" in your "Greens Blend", but do not list the individual ingredients and the total amount of the "Concentrate™ Ionic Trace Minerals (Proprietary Blend)" as required by 21 CFR 101.36(c). Further, the product label lists ingredients in the "Supplement Facts" panel that are not -dietary ingredients (i.e., stevia, natural flavor). These ingredients must be listed outside of the "Supplement Facts" panel as required by 21 CFR 101.4(g). Further, your products do not list vitamins and minerals as individual ingredients as required by 21 CFR 101.36(b)(2) and (3).

Bioterrorism Act

Additionally, the Food and Drug Administration has determined that your facility is subject to the registration requirement in § 415 of the Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H.

During an inspection of your facility located at Valley City, North Dakota, on February 1-2, 2007, you were advised of this requirement. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act 121 U.S.C. § 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.

As the responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this-facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301)575-01'56, or by writing to the agency at the following address:

U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857


When completed, the form may be faxed to (301)210-0247 or mailed to the Rockville, MD, address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.

This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all labels and labeling for products distributed by your firm are in compliance with the Act and its implementing regulations. FDA regulations are available of FDA's web site at www.fda.gov.

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration: without further notice. The Act provides for the seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products.

Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. Include in your response any documentation showing the corrective actions taken or proposed to be taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

TCD/ccl