How The FDA Works to Suppress Knowledge about Nutritional Supplement Benefits

What follows is an actual letter sent by the FDA to owners of a health food store in upstate NY. By reading it, you can see how the FDA literally uses words to make it a crime to share actual, scientifically-verified facts about nutritional and botanical supplements. I explain more about this after the letter.

From the FDA:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website..and has determined that the products "Kyolic Original Formula 100" (200 cap), "Nature's Way Sarsaparilla Root" (100 cap), "Nutrition Now PB 8 Pro-Biotic Acidophilus" (60 cap), and "Nature's Way Alfa-Max" (100 cap) are promoted for conditions that cause the products to be 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)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. (emphasis added) The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Kyolic Original Formula 100 (200 cap)

• "Kyolic Formula 100 ... may be beneficial for ... blood pressure, cholesterol levels, heart disease ... arteriosclerosis, arthritis, asthma, cancer ... infections of the eyes, ears, throat, respiratory infections ... flu ... fungal infections, viral infections ...."

Nature's Way Sarsaparilla Root (100 cap)

• "Sarsaparilla [an ingredient in your product] may help in the treatment of congestive heart failure, high blood pressure impotence ... swelling and discomfort from rheumatism and arthritis ... psoriasis ... syphilis ...."

Nutrition Now PB 8 Pro-Biotic Acidophilus (60 cap)

• "Acidophilus [an ingredient in your product] ... has anti-fungal activity ... and play [sic] a role in yeast infections, urinary tract infections, cancer prevention, cholesterol levels ...."

Nature's Way Alfa-Max (100 cap)

• "Alfalfa [an ingredient in your product] ... may be used for allergies, anemia, arthritis, asthma, blood disorders ... high cholesterol and diabetes ...."

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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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. Furthermore, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, your products "Kyolic Original Formula 100" (200 cap), "Nature's Way Sarsaparilla Root" (100 cap), "Nutrition Now PB 8 Pro-Biotic Acidophilus" (60 cap), and "Nature's Way Alfa-Max" (100 cap) are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.


My Comments

Note this sentence from the FDA's letter: "The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease." By claiming the definition and usage of the word "drug", the FDA makes it illegal for any nutritional supplement company to share any health benefits related to their supplements without prior permission from the FDA (permission that will not be granted).

Also note that in the majority of examples the FDA cites, the website only said "may" in terms of the potential health benefits that the products might provide. More importantly, science does support the benefits attributed to the product. Kyolic, for instance, is a garlic supplement, and garlic has been shown to be beneficial for the conditions the website cites.

But as soon as someone shares these facts in conjunction with selling supplements, the FDA accuses them of a crime because doing so, they claim, means they are marketing "drugs."

But it's perfectly OK for drug companies to hawk their drugs to anyone without such FDA interference. Despite the fact that drugs, properly prescribed and taken, kill over 100,000 Americans each and every year, hospitalize another 2 million people, and cause additional harm to 20 million more, and these are conservative estimates.

This abominable double standard is just one example of how deeply the FDA is in bed with Big Pharma.