Dietary Supplements – Strategies to Reduce FDA Risk

Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.

Previously on the Cohen Healthcare Law Blog

OK, so I am riffing off 24 (and every show that came after it).  Our Health Care and & FDA Law blog has all the thrills and none of the violence.

In a previous post, Dietary Supplement Legal Review Could Save Your Company, we canvassed some key legal rules governing dietary supplement marketing and sales, including:

• Avoiding misbranding
• Creating good structure/function claims as opposed to prohibited, dietary supplement disease claims
• Understanding the 10 ways FDA can consider a statement in your marketing materials, a prohibited dietary supplement disease claim
• Heightened FDA and FTC regulatory scrutiny of weight loss claims for dietary supplement products
• Understanding how OTC drug regulation affects review of dietary supplement marketing materials, websites, and label claims
• Flagging a New Dietary Ingredient (NDI) problem
• Understanding substantiation requirements that both FDA and FTC impose on dietary supplement manufacturers and distributors
• Ensuring you have competent and reliable evidence for health claims
• Understanding basics of applicable state law governing dietary supplements, medical devices, and cosmetics

Now let’s resolve the cliffhanger by applying these principles to some examples.

3 Things Your FDA Lawyer Should Do with Every Dietary Supplement Product

Your FDA lawyer should review each claim separately.

Each claim should be:

• vetted to be sure it is a proper structure/function claim, and not a disease claim;

• tested for substantiation; and

• tested against any special regulatory sensitivity (including by review of guidance and warning letters)—for example, false or misleading weight loss claims.

Ideally, slim the number of claims before getting FDA legal review.

Some distributors make only one or two claims; others like to throw in the kitchen sink.

In a slightly different arena of healthcare care, concierge medicine, read about how use of the descriptor, “exceptional care,” resulted in a multi-million dollar verdict. (Does your concierge medicine advertising create legal jeopardy and liability?)

This is why we say “less is more.”

Case Study of “Less Is More:” A Tribal Formula Raises FDA Specter with Aggressive Claims

The more claims, the more targets for FDA, FTC, or private plaintiffs.

If you read FDA warning letters sent to dietary supplement companies, you’ll see that FDA mentions anything it can.  It’s hard to tell exactly where the violation occurred.  We certainly cannot tell the weight of each violation raised by FDA.

The more claims, the more an FDA lawyer must review – and the more exposed the company … the more opportunity for FDA to knock down more claims in a warning letter.

The number of claims as well as what they say should be reviewed before putting a dietary supplement on the market.

To illustrate, our firm recently reviewed a “miracle” supplement. The product formulation was handed down orally for thousands of years by the client’s representative, who received the formula from the Chief of her tribe.

It’s a bad idea to use the term “miracle” anyway, since this will probably red flag the product with FDA and/or FTC.

At any rate, the “miracles” involved cures of various specific, degenerative diseases.  Now, the supplement, made of rare plants only available in certain jungles or on the Eastern face of certain mountains, perhaps did and could achieve all these results.  But these are disease claims, and at any rate, anecdotal evidence is not enough for substantiation.

Badly Formulated Claims

Here are some of the claims we’ve seen proposed by dietary supplement companies – on mock labels that FDA would probably view as disease claims.

• “Used for colds…staving off the common cold”
• “Lower blood pressure and cholesterol”
• “Lift depression… treat anxiety and depression”
• “Curb migraines”
• Avoid “obesity”

Colds, depression, anxiety, migraines, and obesity are all diseases; references to these diseases make the statements, disease claims.

. As well, references to studies about the effect of the product or one of its ingredients on obesity, will likely be considered disease claims. Such statements need to have qualifying information; however, this FDA also looks to the totality of the evidence to determine whether a disease claim has been made.

Similarly, references to lowering blood pressure and cholesterol are also disease claims, because they imply that a person already has high blood pressure and cholesterol, which are characteristics of disease or disease states. Potentially such references could be shaped into structure/function claims—for example, “helps maintain healthy cholesterol levels already within a normal range” (instead of “lowers cholesterol”).

Substantiation Issues

Dietary supplement companies rarely grasp the fact that every claim must be supported by competent and reliable scientific evidence.  As a result, dietary supplement companies leave themselves open to enforcement action from either FDA or FTC.

Substantiation issues can arise, for example, with these kinds of claims:

• Claims that the product is “clinical proven“
• Claims that the product is supported by evidence that it has certain specific results (in this case, the evidence has to be carefully analyzed to see if it shows what the company says it shows
• Claims about a miracle or magical result
• Claims that are exaggerated (“no need to exercise; pounds melt away!”)
• Claims about a mechanism of action that are made up or hypothetical (they sounds like Doc explaining something in Back to the Future)
• Claims that are so generalized as to be meaningless (“with just one pill, you’ll completely heal!)

Typical Structure/Function Claims

Typical structure/function claims use terms such as:

• stimulates
• maintains
• supports
• regulates
• promotes

in association with a:

• body system
• organ
• or body function

Or a general wellness claim can be made, such as this one: “Use as part of your weight loss plan”

Concluding Thoughts

Remember that you must notify FDA of the proposed (compliant) claim for each product, no later than 30 days after the first marketing of the product.

For a full substantiation review, have studies evaluated evaluated on two grounds: not only (1) to determine whether they substantiate the claims on the website, but also (2) to assess whether they make disease claims (for example, references to studies of the product’s effect on obesity), or, whether suitable qualifying language can be introduced.

What To Do

Be proactive.  Find an FDA and FTC lawyer who can navigate the regulatory thicket.  Invest in legal and regulatory before the regulatory hammer gets thrown.