Inspections, Compliance, Enforcement, and Criminal Investigations
Health Freedom Nutrition, LLC 16-Oct-07
Department of Health and Human Services
Public Health Service
San Francisco District
October 18, 2007
RETURN RECEIPT REQUESTED
Dale T. Fowkes
Chief Executive Officer
Health Freedom Nutrition, LLC
255 Bell St., Second Floor
Reno, NV 89503
Dear Mr. Fowkes:
The Food and Drug Administration (FDA) conducted an inspection at your dietary supplement and drug manufacturing facility located at 255 Bell Street, Reno, Nevada on January 30, 2007, February 2 and 6, 2007. This inspection was 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). In addition, the FDA reviewed your web site at http://www.health-freedom-nutrition.com (also accessible through http://www.hfn-usa.com) on January 31, February 8, May 31, and June 1, 2007. Based on the above referenced inspection and our review of your website, we have concluded that the labeling, marketing and distribution of your products violate the Federal Food, Drug and Cosmetic Act. You can find the Act and implementing regulations through links on FDA's Internet home page at http://www.fda.gov.
Under section 201(g)(1)(B) [21 U.S.C. § 321 (g)(1)(8)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Moreover, under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)], articles other than food that are intended to affect the structure or any function of the body of man are drugs. Based on the claims found in your labeling and on your web site, we have determined that many of your products are promoted for conditions that cause them to be drugs under section 201 (g)(1)(B) and/or 201(g)(1)(C) of the Act. Statements establishing that your products are intended to cure, mitigate, treat, or,prevent disease, or to affect the structure or function of the body, include, but are not limited to, the following:
"Helps treat Alzheimer's disease and memory loss."
"It has been approved as a drug in China to treat Alzheimer's disease and
other age-associated memory impairments."
"Loss of acetylcholine function is a primary feature of several types of brain dysfunction, including Alzheimer's disease. In Alzheimer's disease and senile-dementia, acetylcholine is destroyed too quickly....[h]uperzine inhibits the activity of acetyicholinesterase, so the breakdown of acetylcholine is slowed and the strength and duration of the nerve impulse is improved."
Notoginseng Extract (capsules)
"Aids against angina, lowers cholesterol. . ."
"The herb also reduces cardiac load, lowers arterial pressure, and improves microcirculation in and around damage heart tissue."
"Key antidepressant formula, enhances serotonin levels."
"Prosera enhances serotonin levels. . . .[f]ollowing are just some of the problems that can be caused by low levels. If you have any of these you could have what is known as "Serotonin Deficiency Syndrome"?
Depression; Fibromyalgia; Anxiety; Insomnia;. . .Migraine; Alcoholism; Bulimia; . . .OCR (obsessive-compulsive disorder)"
Emblica Extract (capsules)
"Reduces cholesterol and aortic plaque."
"In a world in which cardiovascular disease is the number one killer, this fruit extract might very well be named the modern day protector."
Cranberry Extract (capsules)
"Cranberry extract has been shown to:
Prevent Bladder Infections
Prevent Tooth Decay
Inhibits Cancer Cell Growth"
Banaba Leaf Extract (capsules)
"[T]he leaves are traditionally used as an herbal medicine to treat diabetes and hyperglycemia (elevated blood sugar)."
"Corosloic acid, a triterpenoid found in the leaves, helps regulate blood sugar by stimulating glucose uptake. This blood sugar lowering effect is similar to that of insulin. . . .[a]nimal studies have shown it to be effective both for treating diabetes and obesity."
In a study of humans with type 2 diabetes, Banaba Extract showed a 30% reduction in blood glucose levels.
Magnolia Extract and Magnolia Max™ (capsules)
"Reduces inflammation and pain."
"Protects against seizures."
"Acts as an antidote for pesticide poisoning."
"Plays a significant role in alleviating and controlling asthma"
"Magnolia has also been traditionally used to treat breast cancer."
"Amazingly, extremely small doses of magnoloi and honokiol are safe and effective for anxiety and depression."
Joint Freedom™ (capsule)
"Reduces pain and inflammation of the joints."
"Arthritis damage stopped or even reversed in as little as 30 to 60 days."
"Cartilage loss halted and cartilage rebuilt."
"Less problems with allergies and asthma."
(Testimonials) "[M]y doctors told me I should expect to have arthritis pain in my ankle for the rest of my life. They were wrong. Thanks to these supplements, which I continue to take, there is no pain at all."
Glucosagen OneTM (capsule)
• "Reduces pain and inflammation due to arthritis damage."
Devil's Claw Extract (capsule)
"Relieves pain of osteoarthritis and lower back pain."
"Devil's Claw extract has been shown to provide relief that is equal to or better than traditional over-the-counter and prescription pain relievers."
TransMist™ (Natural Progesterone Spray)
"Natural progesterone is a supplement for age-related progesterone loss and for balancing estrogen excess."
"I have been on the Transmist for a few years now. The hot flashes were reduced dramatically - mood swings and crying have vanished. The vaginal dryness is also gone. I truly am happy now and enjoy life!"
Linolenic Ester Cream
"This anti-inflammatory topical cream quickly relieves pain and inflammation associated with sore joints or muscles."
"Fast Acting Relief of Pain and Inflammation. This anti-inflammatory cream quickly relieves pain and inflammation associated with sore joints or muscles."
"Ant-inflammatory topical cream reduces pain."
As noted above, these claims cause your products to be drugs, as defined in section 201(g)(1)(B) and 241(9)(1)(C) of the Act [21 U.S.C. §§ 321 (g)(1)(B) and (C)]. Because these products are not generally recognized as safe and effective when used as labeled, they are new drugs as defined in section 201(p) of the Act [21 U.S.C., § 321 (p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). In addition, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that they lack adequate directions for use.
Further, some of the above products are intended to be used in some manner other than ingestion, such as the TransMist natural Progesterone Spray and the Linolenic Ester Cream. Because they are not ingested, they fail to meet the definition of food or dietary supplement under sections 201 (q and 201 (ff)(2)(A) of the Act [21 U.S.C. § § 321 (f) and 321 (ff)(2)(A)].
TransMist Natural Progesterone Spray is subject to final regulations covering topically applied hormone-containing drug products for over-the-counter (OTC) human use. Under 21 C.F.R. Part 310.530(b), a therapeutic claim for the product, or a claim that the product will affect the structure or function of the body, causes the product to be a new drug.
Based on the labeling claims, the product Linolenic Ester Cream is intended for use as a topical analgesic. The website and label emphasize that the product is "formulated with linolenic esters, a new patented compound which uses the powerful anti-inflammatory effects of omega-3 fatty acids." These ingredients are not being evaluated as topical analgesics under the OTC Drug Review, nor are we aware of any OTC marketing history in the U.S. for these ingredients as topical analgesics. Therefore, this product falls outside of the OTC Review and is a new drug within the meaning of section 201(p) of the Act.
Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. As noted above, your products are new drugs that do not have approved applications, and their introduction and delivery into interstate commerce violates sections 301(d) and 505(a) of the Act.
In addition, your products are further misbranded within the meaning of section 502(o) of the Act [21 U.S.C. § 352(o)) in that they are drugs manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act [21 U.S.C. 360] and these products have not been listed as required by section 510(j) of the Act [21 U.S.C. 360(j)].
This letter is not intended to be an all-inclusive list of deficiencies of your products and their labeling. It is your responsibility to ensure that labeling and promotional materials for all products distributed by your firm are in compliance with the Act and its implementing regulations. 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 and/or civil money penalties.
Furthermore, this letter is not intended to be an all-inclusive review of the products your firm markets. You are responsible for ensuring that your facility operates in compliance with the Act and its implementing regulations.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Your reply should be sent to the attention of Compliance Officer Marshalette O. Edwards at the address on the letterhead.
San Francisco District